Can Iron Lessen Anemia Due to Cancer and Chemotherapy: A Study to Investigate the Efficacy and Safety of Injectafer®

NCT02453334 | Completed Phase 3 Results

• 1 other identifier: 1VIT14039
• Study Type: interventional
• Target: 244
• Locations: 1 country
• Sites: 29

Brief Summary

Phase III, multicenter, randomized, double-blinded, prospective study with two parallel treatment groups. Patients who present to the hematologist/oncologist and satisfy all inclusion and exclusion criteria will be eligible for participation in this 18-week study.

Conditions

Cancer and Chemotherapy Related Anemia

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With a Decrease in Hemoglobin ≥ 0.5 g/dL From Week 3 to Week 18

  The following participants will be considered to have met the primary endpoint: * Participants with observed Hgb decrease from baseline between 0.5 g/dL to 1.0 g/dL on two consecutive visits between Weeks 3 and 18. * Participants with observed Hgb decrease from baseline ≥1.0 g/dL at one visit. * Participants who have a non-study intervention prior to Week 18. * Participants who discontinue prior to Week 18 for lack of efficacy or adverse events.

  Week 3 to Week 18

Secondary Outcomes (18)

• Change in Hemoglobin From Baseline to Week 18 or to Nonstudy Intervention

  Baseline to Week 18

• Percentage of Participants With Hemoglobin Increase From Baseline ≥ 1 g/dL at Any Postbaseline Visits Without Receiving a Nonstudy Intervention

  Baseline to Week 18

• Percentage of Participants Who Received Nonstudy Intervention

  Baseline to week 18

• Percentage of Participants With Hemoglobin > 12 g/dL in the Absence of Non-study Intervention

  Baseline to week 18

• Time to Hemoglobin Increase ≥ 1 g/dL in the Absence of Non-study Intervention

  Baseline to Week 18

Study Arms (2)

Injectafer

EXPERIMENTAL

2 doses of Injectafer at 15mg/kg for a maximum single dose of 750mg given 7 days apart for a total of up to 1500mg.

Drug: Injectafer

Normal Saline

PLACEBO COMPARATOR

Normal saline administered as an infusion of no more than 250mL infused over 15 minutes.

Other: Normal Saline

Interventions

Injectafer DRUG

Also known as: ferric carboxymaltose injection

Injectafer

Normal Saline OTHER

Normal Saline

Eligibility Criteria

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

You may qualify if:

• Subjects (male of female) ≥ 18 years of age able to give informed consent to the study.
• Subjects with non-myeloid malignancies
• Receiving chemotherapy as part of their cancer treatment with at least 4 weeks of treatment remaining.
• Screening visit central laboratory hemoglobin (Hgb) ≤11 g/dL, but ≥8 g/dL.
• Ferritin between 100 and 800 ng/mL and transferrin saturation (TSAT) =\<35%
• Subjects must have Eastern Coopertative Oncology Group (ECOG) performance status of 0-2.
• Life expectancy of at least 6 months.
• Demonstrate the ability to understand the requirements of the study, willingness to abide by study restrictions and to return for the required assessments.

You may not qualify if:

• Previous participation in a ferric carboxymaltose clinical trial.
• Known hypersensitivity reaction to any component of ferric carboxymaltose.
• Subjects with overt bleeding
• Subjects on erythropoiesis-stimulating agents.
• Requiring dialysis for the treatment of chronic kidney disease.
• Any non-viral infection.
• Known positive hepatitis with evidence of active disease.
• Received an investigational drug within 30 days of screening.
• Alcohol or drug abuse within the past 6 months.
• Hemochromatosis or other iron storage disorders.
• Any other laboratory abnormality, medical condition or psychiatric disorders which in the opinion of the Investigator would put the subject's disease management at risk or may result in the subject being unable to comply with study requirements.
• Pregnant or actively trying to become pregnant (Female subjects who are of childbearing age must have a negative pregnancy test at screening and be practicing an acceptable method of birth control during the study).

Sponsors & Collaborators

• American Regent, Inc.: lead

Study Sites (29)

Compassionate Care Research Group, Inc.

Corona, California, 92879, United States

Location

Compassionate Care Research Group, Inc.

Fountain Valley, California, 92708, United States

Location

Compassionate Care Research Group, Inc.

Riverside, California, 92501, United States

Location

University Cancer Institute

Boynton Beach, Florida, 33426, United States

Location

AR Development Solutions

Miami Lakes, Florida, 33014, United States

Location

Lakes Research

Miami Lakes, Florida, 33014, United States

Location

H. Lee Moffitt Cancer Center

Tampa, Florida, 33606, United States

Location

Bond Bond Clinic, P.A.

Winter Haven, Florida, 33880, United States

Location

Joliet Oncology Hematology Associates

Joliet, Illinois, 60435, United States

Location

MId-Illinois Hematology & Oncology Associates, Ltd.

Normal, Illinois, 61761, United States

Location

OSF Saint Anthony Medical Center for Cancer Care

Rockford, Illinois, 61108, United States

Location

Horizon Oncology Research, Inc.

Lafayette, Indiana, 47905, United States

Location

Michiana Hematology Oncology, PC

South Bend, Indiana, 46628, United States

Location

Northern Indiana Cancer Research Consortium

South Bend, Indiana, 46628, United States

Location

Ashland-Bellefonte Cancer Center

Ashland, Kentucky, 41101, United States

Location

Rcca Md, Llc

Bethesda, Maryland, 20817, United States

Location

Antietam Oncology and Hematology Group, P.C.

Hagerstown, Maryland, 21740, United States

Location

North Mississippi and Oncology Associates

Tupelo, Mississippi, 38801, United States

Location

The Brookdale University Hospital and Medical Center

Brooklyn, New York, 11212, United States

Location

Richmond University Medical Center

Staten Island, New York, 10310, United States

Location

Montefiore Medical Center

The Bronx, New York, 10467, United States

Location

East Chester Cancer Center

The Bronx, New York, 10469, United States

Location

Waverly Hematology Oncology

Cary, North Carolina, 27518, United States

Location

Kinston Medical Specialists

Kinston, North Carolina, 28501, United States

Location

Gettysburg Cancer Center

Gettysburg, Pennsylvania, 17325, United States

Location

Charleston Hematology/Oncology Associates, P.A.

Charleston, South Carolina, 29414, United States

Location

Carolina Blood and Cancer Care, PA

Rock Hill, South Carolina, 29732, United States

Location

Westchase Clinical Associates

Houston, Texas, 77042, United States

Location

Bon Secours St. Francis Medical Center

Midlothian, Virginia, 23114, United States

Location

MeSH Terms

Conditions

Neoplasms

Interventions

ferric carboxymaltose; Saline Solution

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Results Point of Contact

• Title: Mark A. Falone, MD MPH
• Organization: American Regent, Inc

mfalone@americanregent.com

631-772-3544

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

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

Study Record Dates

• First Submitted: May 21, 2015
• First Posted: May 25, 2015
• Study Start: May 23, 2015
• Primary Completion: January 1, 2018
• Study Completion: January 4, 2018
• Last Updated: May 11, 2021
• Results First Posted: May 10, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will share

Locations

US (29)