Anemia Treatment for Advanced Non-Small Cell Lung Cancer (NSCLC) Patients Receiving Chemotherapy
A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Long-term Safety and Efficacy of Darbepoetin Alfa Administered at 500 µg Once-Every-3-Weeks in Anemic Subjects With Advanced Stage Non-small Cell Lung Cancer Receiving Multi-cycle Chemotherapy
2 other identifiers
interventional
2,549
37 countries
566
Brief Summary
This is a study in patients with chemotherapy induced anemia receiving multi-cycle chemotherapy for the treatment of stage IV non-small cell lung cancer (NSCLC). The primary objective of the study is to demonstrate that overall survival (OS) is not worse in participants on darbepoetin alfa treated to a hemoglobin ceiling of 12.0 g/dL compared to participants treated with placebo.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 nonsmall-cell-lung-cancer
Started Jul 2009
Longer than P75 for phase_3 nonsmall-cell-lung-cancer
566 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 5, 2009
CompletedFirst Posted
Study publicly available on registry
March 9, 2009
CompletedStudy Start
First participant enrolled
July 17, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 7, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
June 7, 2017
CompletedResults Posted
Study results publicly available
July 6, 2018
CompletedNovember 30, 2022
November 1, 2022
7.9 years
March 5, 2009
June 7, 2018
November 4, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Overall Survival (OS)
Overall survival (OS) was defined as the time from randomization to the date of death due to any cause. Participants were censored on the date of last contact (ie, the date the participant was last known to be alive) if they were not known to have died.
From randomization until death or end of study; maximum time on follow-up was 93.6 months.
Secondary Outcomes (7)
Progression-free Survival (PFS)
From randomization until disease progression or death; maximum time on follow-up was 87.23 months.
Percentage of Participants With a Red Blood Cell Transfusion or Hemoglobin ≤ 8.0 g/dL From Week 5 to End of the Efficacy Treatment Period
Week 5 (day 29) to end of the efficacy treatment period (EOETP; defined as 21 days after either the last dose of study drug or the last dose of chemotherapy, whichever was later); median (range) duration of dosing was 10 (1 to 106) weeks in both groups.
Number of Participants With Adverse Events of Special Interest
From first dose of study drug until 30 days after last dose; the median (range) duration of treatment was 10 (1 to 106) weeks in both groups.
Percentage of Participants With an Objective Tumor Response
Day 1 to end of the efficacy treatment period (EOETP; defined as 21 days after either the last dose of study drug or the last dose of chemotherapy, whichever was later); median (range) duration of dosing was 10 (1 to 106) weeks in both groups.
Number of Participants Who Developed Neutralizing Antibodies to Darbepoetin Alfa
Baseline and end of the efficacy treatment period (EOETP; defined as 21 days after either the last dose of study drug or the last dose of chemotherapy, whichever was later. the median (range) duration of treatment was 10 (1 to 106) weeks in both groups.
- +2 more secondary outcomes
Study Arms (2)
Placebo
PLACEBO COMPARATORParticipants received placebo once every 3 weeks (Q3W) administered subcutaneously until 3 weeks after the completion of chemotherapy or upon determination of disease progression, whichever occurred first.
Darbepoetin alfa
EXPERIMENTALParticipants received darbepoetin alfa 500 µg once every 3 weeks (Q3W) administered subcutaneously until 3 weeks after the completion of chemotherapy or upon determination of disease progression, whichever occurred first.
Interventions
Administered subcutaneously once every 3 weeks
Eligibility Criteria
You may qualify if:
- Subjects with stage IV NSCLC (not recurrent or re-staged).
- Expected to receive at least 2 additional cycles (at least 6 total weeks) of first line myelosuppressive cyclic chemotherapy after randomization. Subjects should not be expected to receive only maintenance chemotherapy.
- Eastern Cooperative Oncology Group performance status of 0 or 1 as assessed within 21 days prior to randomization.
- years of age or older at screening.
- Life expectancy greater than 6 months based on the judgment of the investigator and documented during screening.
- Hemoglobin level less than or equal to 11.0 g/dL as assessed by the local laboratory; sample obtained within 7 days prior to randomization (retest in screening is acceptable).
- Adequate serum folate (greater than or equal to 2 ng/mL) and vitamin B12 (greater than or equal to 200 pg/mL) levels assessed by central laboratory (supplementation and retest acceptable) during screening.
- Subjects must have had a baseline scan (computed tomography \[CT\], magnetic resonance imaging \[MRI\], or positron emission tomography-computer tomography \[PET/CT\]) of the chest to assess disease burden before starting on first line chemotherapy for NSCLC and those images must have been reviewed by the investigator prior to randomization. If the scan was performed more than 28 days prior to randomization, an additional scan must be performed and reviewed by the investigator to confirm that the patient has not progressed before randomization.
- Before any study-specific procedure, the appropriate written informed consent must be obtained from the subject or a legally accepted representative.
You may not qualify if:
- Known primary benign or malignant hematologic disorder which can cause anemia.
- History of, or current active cancer other than NSCLC, with the exception of curatively resected non-melanomatous skin cancer, curatively treated cervical carcinoma in situ, or other primary solid tumors curatively treated with no known active disease present and no curative treatment administered for the last 3 years.
- Received any prior adjuvant or neoadjuvant therapy for NSCLC.
- Subjects with a history of brain metastasis.
- Uncontrolled hypertension (systolic blood pressure \[BP\] \> 160 mmHg or diastolic BP \> 100 mmHg), or as determined by the investigator during screening.
- History of neutralizing antibody activity to recombinant human erythropoietin (rHuEPO) or darbepoetin alfa.
- Uncontrolled angina, uncontrolled heart failure, or uncontrolled cardiac arrhythmia as determined by the investigator at screening. Subjects with known myocardial infarction within 6 months prior to randomization.
- Subjects with a history of seizure disorder taking anti-seizure medication within 30 days prior to randomization.
- Clinically significant systemic infection or uncontrolled chronic inflammatory disease (eg, rheumatoid arthritis, inflammatory bowel disease) as determined by the investigator during screening.
- Known seropositivity for human immunodeficiency virus (HIV) or diagnosis of acquired immunodeficiency syndrome (AIDS), positive for hepatitis B surface antigen, or seropositive for hepatitis C virus
- History of pure red cell aplasia
- History of deep venous thrombosis or embolic event (eg, pulmonary embolism) within 6 months prior to randomization.
- Transferrin saturation \< 20% and ferritin \< 50 ng/mL as assessed by the central laboratory during screening. Subjects must have both to be excluded (supplementation and retest acceptable).
- Abnormal renal function (serum creatinine level \> 2X upper limit of normal \[ULN\]) as assessed by the central laboratory during screening.
- Abnormal liver function (total bilirubin \> 2X ULN or liver enzymes alanine aminotransferase \[ALT\] or aspartate aminotransferase \[AST\] \> 2.5X ULN for subjects without liver metastasis or ≥ 5X ULN for subjects with liver metastasis) as assessed by the central laboratory during screening. Subjects with documented Gilbert's Disease may be eligible.
- +9 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Amgenlead
Study Sites (566)
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Anniston, Alabama, 36207, United States
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Birmingham, Alabama, 35216, United States
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Anchorage, Alaska, 99508, United States
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Tucson, Arizona, 85704, United States
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Fayetteville, Arkansas, 72703, United States
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Hot Springs, Arkansas, 71913, United States
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Jonesboro, Arkansas, 72401, United States
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Little Rock, Arkansas, 72205, United States
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Anaheim, California, 92801, United States
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Arcadia, California, 91007, United States
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Berkeley, California, 94704, United States
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Burbank, California, 91505, United States
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Downey, California, 90241, United States
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Fountain Valley, California, 92708, United States
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Fresno, California, 93703, United States
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Fresno, California, 93720, United States
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La Verne, California, 91750, United States
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Lancaster, California, 93534, United States
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Long Beach, California, 90822, United States
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Los Angeles, California, 90024, United States
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Los Angeles, California, 90027, United States
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Los Angeles, California, 90048, United States
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Merced, California, 95348, United States
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Mission Hills, California, 91345, United States
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Montebello, California, 90640, United States
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Oxnard, California, 93030, United States
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Palm Springs, California, 92262, United States
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Pismo Beach, California, 93449, United States
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Pomona, California, 91767, United States
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Redlands, California, 92374, United States
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Salinas, California, 93901, United States
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San Diego, California, 92161, United States
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Santa Rosa, California, 95403, United States
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Simi Valley, California, 93065, United States
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Soquel, California, 95073, United States
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St. Helena, California, 94574, United States
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Torrance, California, 90501, United States
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Vallejo, California, 94589, United States
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West Covina, California, 91790, United States
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Denver, Colorado, 80210, United States
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Denver, Colorado, 80218, United States
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Englewood, Colorado, 80113, United States
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Bridgeport, Connecticut, 06610, United States
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Southington, Connecticut, 06489, United States
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Washington D.C., District of Columbia, 20037, United States
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Washington D.C., District of Columbia, 20060, United States
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Boynton Beach, Florida, 33426, United States
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Boynton Beach, Florida, 33435, United States
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Coral Springs, Florida, 33065, United States
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Daytona Beach, Florida, 32114, United States
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Fort Lauderdale, Florida, 33316, United States
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Holiday, Florida, 34691, United States
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Hollywood, Florida, 33021, United States
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Jacksonville, Florida, 32256, United States
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Kissimmee, Florida, 34741, United States
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Lake Worth, Florida, 33461, United States
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Lakeland, Florida, 33805, United States
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Lecanto, Florida, 34461, United States
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Miami, Florida, 33133, United States
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New Port Richey, Florida, 34652, United States
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New Port Richey, Florida, 34655, United States
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Orange City, Florida, 32763, United States
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Orlando, Florida, 32806, United States
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Pembroke Pines, Florida, 33029, United States
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Rockledge, Florida, 32955, United States
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Tamarac, Florida, 33321, United States
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The Villages, Florida, 32159, United States
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Titusville, Florida, 32796, United States
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Weston, Florida, 33331, United States
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Albany, Georgia, 31701, United States
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Augusta, Georgia, 30901, United States
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Stockbridge, Georgia, 30281, United States
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Thomasville, Georgia, 31792, United States
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Chicago, Illinois, 60616, United States
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Chicago, Illinois, 60640, United States
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Galesburg, Illinois, 61401, United States
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Gurnee, Illinois, 60031, United States
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Mount Vernon, Illinois, 62864, United States
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Skokie, Illinois, 60077, United States
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Indianapolis, Indiana, 46219, United States
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Michigan City, Indiana, 46360, United States
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Muncie, Indiana, 47303, United States
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Council Bluffs, Iowa, 51503, United States
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Dubuque, Iowa, 52001, United States
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Iowa City, Iowa, 52242, United States
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Sioux City, Iowa, 51101, United States
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Waterloo, Iowa, 50702, United States
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Hutchinson, Kansas, 67502, United States
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Wichita, Kansas, 67214, United States
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Ashland, Kentucky, 41101, United States
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Hazard, Kentucky, 41701, United States
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Louisville, Kentucky, 40202, United States
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Louisville, Kentucky, 40207, United States
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Morehead, Kentucky, 40351, United States
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Mount Sterling, Kentucky, 40353, United States
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Paducah, Kentucky, 42001, United States
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Paducah, Kentucky, 42003, United States
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Alexandria, Louisiana, 71301, United States
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Lafayette, Louisiana, 70503, United States
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Marrero, Louisiana, 70072, United States
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New Orleans, Louisiana, 70112, United States
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Ruston, Louisiana, 71270, United States
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Shreveport, Louisiana, 71103, United States
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Lewiston, Maine, 04240, United States
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Rockport, Maine, 04856, United States
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Baltimore, Maryland, 21215, United States
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Baltimore, Maryland, 21218, United States
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Baltimore, Maryland, 21237, United States
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Bethesda, Maryland, 20817, United States
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Chevy Chase, Maryland, 20815, United States
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Cumberland, Maryland, 21502, United States
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Frederick, Maryland, 21701, United States
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Hagerstown, Maryland, 21742, United States
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Towson, Maryland, 21204, United States
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Westminster, Maryland, 21157, United States
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Attleboro, Massachusetts, 02703, United States
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Boston, Massachusetts, 02130, United States
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Boston, Massachusetts, 02135, United States
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Brockton, Massachusetts, 02302, United States
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Cambridge, Massachusetts, 02138, United States
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Worcester, Massachusetts, 01608, United States
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Clarkston, Michigan, 48346, United States
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Grand Rapids, Michigan, 49503, United States
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Kalamazoo, Michigan, 49048, United States
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Southfield, Michigan, 48075, United States
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Southgate, Michigan, 48195, United States
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Willmar, Minnesota, 56201, United States
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Biloxi, Mississippi, 39531, United States
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Hattiesburg, Mississippi, 39401, United States
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Jackson, Mississippi, 39216, United States
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Tupelo, Mississippi, 38801, United States
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Columbia, Missouri, 65201, United States
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Jefferson City, Missouri, 65101, United States
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Kansas City, Missouri, 64111, United States
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Kansas City, Missouri, 64132, United States
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Springfield, Missouri, 65807, United States
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St Louis, Missouri, 63110, United States
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St Louis, Missouri, 63136, United States
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Great Falls, Montana, 59405, United States
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Kalispell, Montana, 59901, United States
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Grand Island, Nebraska, 68803, United States
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Omaha, Nebraska, 68105, United States
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Omaha, Nebraska, 68106, United States
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Henderson, Nevada, 89052, United States
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North Las Vegas, Nevada, 89086, United States
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Manchester, New Hampshire, 03102, United States
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Sparta, New Jersey, 07871, United States
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Teaneck, New Jersey, 07666, United States
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Vineland, New Jersey, 08360, United States
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Albuquerque, New Mexico, 87109-4397, United States
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Santa Fe, New Mexico, 87505, United States
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Albany, New York, 12208, United States
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Brooklyn, New York, 11212, United States
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Buffalo, New York, 14215, United States
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Glens Falls, New York, 12801, United States
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Goshen, New York, 10924, United States
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Lake Success, New York, 11042, United States
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Latham, New York, 12110-0610, United States
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Nyack, New York, 10960, United States
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Poughkeepsie, New York, 12601, United States
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Staten Island, New York, 10301, United States
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Staten Island, New York, 10310, United States
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Syracuse, New York, 13210, United States
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Valhalla, New York, 10595, United States
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Asheboro, North Carolina, 27203, United States
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Asheville, North Carolina, 28801, United States
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Burlington, North Carolina, 27215, United States
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Concord, North Carolina, 28025, United States
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Durham, North Carolina, 27704, United States
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Goldsboro, North Carolina, 27534, United States
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Greenville, North Carolina, 27834, United States
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Hendersonville, North Carolina, 28791, United States
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Hickory, North Carolina, 28602, United States
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High Point, North Carolina, 27262, United States
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Huntersville, North Carolina, 28078, United States
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Kinston, North Carolina, 28501, United States
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Pinehurst, North Carolina, 28374, United States
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Raleigh, North Carolina, 27607, United States
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Washington, North Carolina, 27889, United States
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Bismarck, North Dakota, 58501, United States
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Akron, Ohio, 44304, United States
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Columbus, Ohio, 43235, United States
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Dayton, Ohio, 45428, United States
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Massillon, Ohio, 44646, United States
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Middletown, Ohio, 45042, United States
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Port Clinton, Ohio, 43452, United States
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Sylvania, Ohio, 43560, United States
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Wooster, Ohio, 44691, United States
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Oklahoma City, Oklahoma, 73102, United States
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Tulsa, Oklahoma, 74104, United States
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Bethlehem, Pennsylvania, 18015, United States
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Gettysburg, Pennsylvania, 17325, United States
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Langhorne, Pennsylvania, 19047, United States
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Philadelphia, Pennsylvania, 19102, United States
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Philadelphia, Pennsylvania, 19106, United States
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Philadelphia, Pennsylvania, 19107, United States
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Philadelphia, Pennsylvania, 19140, United States
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Philadelphia, Pennsylvania, 19141, United States
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Pittsburgh, Pennsylvania, 15240, United States
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Upland, Pennsylvania, 19013, United States
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Willow Grove, Pennsylvania, 19090, United States
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Wynnewood, Pennsylvania, 19096, United States
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Pawtucket, Rhode Island, 02860, United States
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Providence, Rhode Island, 02908, United States
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Woonsocket, Rhode Island, 02895, United States
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Aiken, South Carolina, 29801, United States
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Charleston, South Carolina, 29406, United States
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Charleston, South Carolina, 29414, United States
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Columbia, South Carolina, 29210, United States
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Hilton Head Island, South Carolina, 29926, United States
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Myrtle Beach, South Carolina, 29572, United States
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Sumter, South Carolina, 29150, United States
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Aberdeen, South Dakota, 57401, United States
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Sioux Falls, South Dakota, 57105, United States
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Watertown, South Dakota, 57201, United States
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Johnson City, Tennessee, 37604, United States
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Knoxville, Tennessee, 37920, United States
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Memphis, Tennessee, 38104, United States
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Memphis, Tennessee, 38120, United States
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Nashville, Tennessee, 37203, United States
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Abilene, Texas, 79606-5208, United States
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Amarillo, Texas, 79106, United States
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Austin, Texas, 78731, United States
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Beaumont, Texas, 77702, United States
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Bedford, Texas, 76022, United States
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Bryan, Texas, 77802, United States
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Corpus Christi, Texas, 78405, United States
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Corpus Christi, Texas, 78412, United States
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Dallas, Texas, 75230-2510, United States
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Dallas, Texas, 75231, United States
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Dallas, Texas, 75237, United States
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El Paso, Texas, 79905, United States
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El Paso, Texas, 79915, United States
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Fort Worth, Texas, 76104, United States
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Garland, Texas, 75042, United States
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Harlingen, Texas, 78550, United States
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Houston, Texas, 77055, United States
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Irving, Texas, 75063, United States
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Longview, Texas, 75601, United States
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McAllen, Texas, 78503-1298, United States
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Mesquite, Texas, 75150, United States
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Midland, Texas, 79701-5946, United States
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Paris, Texas, 75460-5004, United States
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Richardson, Texas, 75082, United States
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Round Rock, Texas, 78665, United States
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San Antonio, Texas, 78217, United States
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San Antonio, Texas, 78229, United States
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Sherman, Texas, 75090, United States
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Southlake, Texas, 76092, United States
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Sugar Land, Texas, 77479, United States
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Temple, Texas, 76508, United States
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The Woodlands, Texas, 77380, United States
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Tyler, Texas, 75701, United States
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Tyler, Texas, 75702, United States
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Waco, Texas, 76712, United States
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Webster, Texas, 77598, United States
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Wichita Falls, Texas, 76310, United States
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Ogden, Utah, 84403, United States
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White River Junction, Vermont, 05009, United States
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Christiansburg, Virginia, 24073, United States
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Fairfax, Virginia, 22031, United States
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Lynchburg, Virginia, 24501, United States
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Newport News, Virginia, 23601, United States
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Portsmouth, Virginia, 23704, United States
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Bremerton, Washington, 98310, United States
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Burien, Washington, 98166, United States
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Edmonds, Washington, 98026, United States
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Seattle, Washington, 98133, United States
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Spokane, Washington, 99202, United States
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Spokane, Washington, 99208, United States
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Spokane, Washington, 99218, United States
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Tacoma, Washington, 98405, United States
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Vancouver, Washington, 98684, United States
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Yakima, Washington, 98902, United States
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Green Bay, Wisconsin, 54311, United States
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Janesville, Wisconsin, 53548, United States
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Milwaukee, Wisconsin, 53211, United States
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Quilmes, Buenos Aires, B1878DVB, Argentina
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Quilmes, Buenos Aires, B1878GEG, Argentina
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Córdoba, Córdoba Province, X5006HBF, Argentina
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Buenos Aires, Distrito Federal, C1019ABS, Argentina
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Buenos Aires, Distrito Federal, C1185AAT, Argentina
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San Salvador de Jujuy, Jujuy Province, 4600, Argentina
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Rosario, Santa Fe Province, S2000CVD, Argentina
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Rosario, Santa Fe Province, S2002KDS, Argentina
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San Miguel de Tucumán, Tucumán Province, T4000GTB, Argentina
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Buenos Aires, C1180AAX, Argentina
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La Rioja, F5300COE, Argentina
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Santa Fe, S3000FFU, Argentina
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Steyr, 4400, Austria
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Vienna, 1090, Austria
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Ieper, 8900, Belgium
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Libramont, 6800, Belgium
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Liège, 4000, Belgium
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Namur, 5000, Belgium
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Ottignies, 1340, Belgium
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Fortaleza, Ceará, 60336-045, Brazil
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Fortaleza, Ceará, 60430-230, Brazil
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Cachoeiro de Itapemirim, Espírito Santo, 29308-020, Brazil
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Salvador, Estado de Bahia, 40170-110, Brazil
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Brasília, Federal District, 72110-150, Brazil
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Campo Grande, Mato Grosso do Sul, 79010-050, Brazil
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Belo Horizonte, Minas Gerais, 30110-090, Brazil
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Belo Horizonte, Minas Gerais, 30150-281, Brazil
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Belo Horizonte, Minas Gerais, 30150-321, Brazil
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Belo Horizonte, Minas Gerais, 30285-000, Brazil
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Curitba, Paraná, 81520-060, Brazil
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Curitiba, Paraná, 80010-030, Brazil
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Curitiba, Paraná, 80530-010, Brazil
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Londrina, Paraná, 86050-190, Brazil
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Belém, Pará, 66053-000, Brazil
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Ijuí, Rio Grande do Sul, 98700-000, Brazil
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Passo Fundo, Rio Grande do Sul, 99010-260, Brazil
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Pelotas, Rio Grande do Sul, 96015-280, Brazil
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Porto Alegre, Rio Grande do Sul, 90035-001, Brazil
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Porto Alegre, Rio Grande do Sul, 90610-000, Brazil
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Porto Alegre, Rio Grande do Sul, 90840-440, Brazil
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Itajaí, Santa Catarina, 88301-220, Brazil
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Ribeirão Preto, São Paulo, 14015-130, Brazil
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Santo André, São Paulo, 09060-650, Brazil
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Santo André, São Paulo, 09090-780, Brazil
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São José dos Campos, São Paulo, 12245-750, Brazil
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São Paulo, São Paulo, 01221-020, Brazil
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São Paulo, São Paulo, 08270-070, Brazil
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Rio de Janeiro, 22260-020, Brazil
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Rio de Janeiro, 22640-000, Brazil
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Rio de Janeiro, 22793-080, Brazil
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São Paulo, 01246-000, Brazil
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Rousse, 7002, Bulgaria
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Sofia, 1233, Bulgaria
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Sofia, 1784, Bulgaria
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Varna, 9000, Bulgaria
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Moncton, New Brunswick, E1C 6Z8, Canada
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Oshawa, Ontario, L1G 2B9, Canada
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Toronto, Ontario, M9N 1N8, Canada
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Montreal, Quebec, H2W 1S6, Canada
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Saint-Jérôme, Quebec, J7Z 5T3, Canada
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Temuco, Cautín, 4810469, Chile
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Reñaca, Región de Valparaíso, Chile
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Santiago, 7500006, Chile
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Santiago, 7571831, Chile
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Santiago, 8380455, Chile
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Beijing, Beijing Municipality, 100191, China
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Chongqing, Chongqing Municipality, 400038, China
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Fuzhou, Fujian, 350001, China
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Fuzhou, Fujian, 350025, China
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Lanzhou, Gansu, 730050, China
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Guangzhou, Guangdong, 510010, China
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Guangzhou, Guangdong, 510060, China
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Guangzhou, Guangdong, 510120, China
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Zhongshan, Guangdong, 528403, China
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Haikou, Hainan, 570102, China
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Haikou, Hainan, 570311, China
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Shijiazhuang, Hebei, 050011, China
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Harbin, Heilongjiang, 150081, China
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Wuhan, Hubei, 430030, China
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Related Publications (1)
Gascon P, Nagarkar R, Smakal M, Syrigos KN, Barrios CH, Sanchez JC, Zhang L, Henry DH, Gordon D, Hirsh V, Kubota K, Orlov S, Thomas G, Steinmetz T, Kang JH, Tomita DK, Fleishman AN, Park JK, De Oliveira Brandao C. A Randomized, Double-Blind, Placebo-Controlled, Phase III Noninferiority Study of the Long-Term Safety and Efficacy of Darbepoetin Alfa for Chemotherapy-Induced Anemia in Patients With Advanced NSCLC. J Thorac Oncol. 2020 Feb;15(2):190-202. doi: 10.1016/j.jtho.2019.10.005. Epub 2019 Oct 16.
PMID: 31629060BACKGROUND
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study Director
- Organization
- Amgen Inc.
Study Officials
- STUDY DIRECTOR
MD
Amgen
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 5, 2009
First Posted
March 9, 2009
Study Start
July 17, 2009
Primary Completion
June 7, 2017
Study Completion
June 7, 2017
Last Updated
November 30, 2022
Results First Posted
July 6, 2018
Record last verified: 2022-11