A Novel Erythropoiesis Stimulating Protein (NESP; Darbopoetin Alfa) for the Treatment of Anemia in Lung Cancer Patients Receiving Multi-cycle Platinum-Containing Chemotherapy

NCT03776032 | Completed Phase 3 FDA Drug

• 1 other identifier: 00980297
• Study Type: interventional
• Target: 320
• Locations: 0 countries
• Sites: N/A

Brief Summary

The primary objective of this study was to compare the effectiveness of darbopoetin alfa to placebo in the treatment of anemia in adults with lung cancer receiving multicycle platinum-containing chemotherapy, by assessing the percentage of participants who received red blood cell (RBC) transfusions during weeks 5-12 inclusive.

Conditions

Anemia

Keywords

Lung cancer

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants with a Red Blood Cell Transfusion During Weeks 5 to 12

  Weeks 5 to 12

Secondary Outcomes (15)

• Time to First Red Blood Cell Transfusion During Weeks 5 to 12

  Week 5 to week 12

• Percentage of Participants with a Hemoglobin Response by Week 12

  12 weeks

• Time to Hemoglobin Response

  12 weeks

• Percentage of Participants who Achieved a Sustained Hemoglobin Response by Week 12

  12 weeks

• Time to Sustained Hemoglobin Response

  12 weeks

Study Arms (2)

Darbepoetin alfa

EXPERIMENTAL

Participants received once a week darbepoetin alfa, administered by subcutaneous injection at a starting dose of 2.25 µg/kg for up to 12 weeks. The dose of darbepoetin alfa may have been adjusted based on hemoglobin levels to a maximum dose of 4.5 µg/kg /week.

Drug: Darbepoetin alfa

Placebo

PLACEBO COMPARATOR

Participants received once a week placebo, administered by subcutaneous injection for up to 12 weeks.

Drug: Placebo

Interventions

Darbepoetin alfa DRUG

Administered by subcutaneous injection once a week

Also known as: Novel Erythropoiesis Stimulating Protein (NESP), Aranesp

Darbepoetin alfa

Placebo DRUG

Placebo matching to darbopoetin alfa administered by subcutaneous injection once a week.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Lung cancer (either small cell \[SCLC\] or non-small cell \[NSCLC\])
• At least 12 additional weeks of platinum containing cyclic chemotherapy planned regardless of cycle length
• Anemia (hemoglobin ≤ 11.0 g/dL) as assessed by a local or central laboratory result within 7 days before study day 1 (the first scheduled day of on-study chemotherapy and the first day of study drug administration)
• Life expectancy of at least 6 months, and an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.
• Anemia predominantly due to the cancer or chemotherapy (i.e.. serum folate ≥ 4.5 nmol/L (≥ 2.0 ng/mL) and vitamin B 12 ≥ 148 pmol/L (≥ 200 pg/mL), no overt hemolysis, and no overt gastrointestinal bleeding or bleeding due to recent surgery)
• Adequate renal function (creatinine ≤ 177gmol/L (≤ 2.0 mg/dL) and adequate hepatic function (bilirubin ≤ 1.5 times central laboratory's upper limit of normal range)
• Available for 4 weeks post administration of the last dose of study drug
• Legal age for informed consent, and written informed consent must be obtained

You may not qualify if:

• History of any primary hematological disorder which could cause anemia (e.g., sickle cell anemia)
• Received prior whole pelvis radiation therapy
• Uncontrolled angina, congestive heart failure (New York Heart Association \> class II or known ejection fraction \< 40%)\], or uncontrolled cardiac arrhythmia.
• History of primary or metastatic malignancy involving the central nervous system (CNS). Subjects with a previous history of primary or metastatic malignancy involving the CNS will be eligible for the study providing they have had no clinical signs of nor treatment for CNS disease and no history of seizures within previous 2 years
• Uncontrolled hypertension (i.e., diastolic blood pressure \> 100 mm Hg)
• History of seizures. Subjects with a previous history of seizures will be eligible for the study providing they have had no evidence of seizure activity and have been free of anti-seizure medication for the previous 5 years
• Evidence of clinically significant systemic active infection or chronic inflammatory disease (e.g., rheumatoid arthritis)
• Iron deficiency (transferrin saturation \< 15% and ferritin \< 10 μg/L (\< 10 ng/mL))
• Received \> 2 RBC transfusions within 4 weeks before randomization or any RBC transfusion within 2 weeks before randomization
• Received erythropoietin therapy within 8 weeks before randomization
• Known positive test for human immunodeficiency virus (HIV) infection
• Receiving, or not yet 30 days past the end of receiving, another investigational agent or device not approved in any indication.
• Pregnant or breast feeding females.
• Not using adequate contraceptive precautions
• Prior treatment with NESP

Sponsors & Collaborators

• Amgen: lead

MeSH Terms

Conditions

Anemia; Lung Neoplasms

Interventions

Darbepoetin alfa

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Erythropoietin; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Proteins; Amino Acids, Peptides, and Proteins

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 13, 2018
• First Posted: December 14, 2018
• Study Start: September 14, 1999
• Primary Completion: November 8, 2000
• Study Completion: February 27, 2002
• Last Updated: December 20, 2018

Record last verified: 2018-12