AIM 3: Anemia and Iron Management With Every 3 Week Dosing in Anemic Subjects With Nonmyeloid Malignancies

Cancer Clinical Trial

Official title:

A Randomized Open-Label Study of Darbepoetin Alfa Administered Every Three Weeks With or Without Parenteral Iron in Anemic Subjects With Nonmyeloid Malignancies Receiving Chemotherapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00135317
• Other study ID #: 20040156
• Status: Completed
• Phase: Phase 3
• First received: August 24, 2005
• Last updated: May 21, 2013
• Start date: November 2004

Study information

• Verified date: May 2013
• Source: Amgen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial Summary

The study is designed to assess if the addition of intravenous (IV) iron to 500 mcg every 3 week (Q3W) darbepoetin alfa treatment enhances response as compared to the standard practice (oral iron or no iron administration).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria: - Subjects with non-myeloid malignancy (chronic myeloid leukemia [CML], acute leukemia [acute myelogenous leukemia (AML) and acute lymphocytic leukemia (ALL)], hairy cell leukemia, Burkitt's lymphoma and lymphoblastic lymphoma are specifically excluded) - Planned to receive at least 8 weeks of cyclic cytotoxic chemotherapy regardless of schedule (chemotherapy may already be ongoing at time of screening) - Hemoglobin concentration less than 11 g/dL within 24 hours before randomization - Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 Exclusion Criteria: - Known (documented in medical records) history of seizure disorder (subjects with a previous history of seizure disorders will be eligible for the study, if they have had no evidence of seizure activity, and have not been taking anti-seizure medication for the previous 5 years) - Known (documented in medical records) history of thromboembolism - Known primary hematologic disorder which could cause anemia other than a non-myeloid malignancy (e.g., sickle cell anemia, thalassemia) - Radiotherapy within 4 weeks before randomization in which the radiation is administered to greater than 25% of the marrow - Unstable or uncontrolled disease/condition, related to or affecting cardiac function (e.g., unstable angina, congestive heart failure, uncontrolled hypertension and/or unstable cardiac arrhythmia) - Chronic inflammatory disease that is not stable (e.g., rheumatoid arthritis, Crohn's disease, peptic ulcer, ulcerative disease, etc) - Inadequate renal and/or liver function - Received any red blood cell transfusion within 14 days before randomization or any planned red blood cell transfusion between randomization and study day 1 - Received any erythropoietic therapy within 4 weeks before randomization or any planned erythropoietic therapy between randomization and study day 1 - Known sensitivity to iron administration - Subject of reproductive potential is evidently pregnant (e.g., positive serum HCG test) or is breast feeding - Subject of reproductive potential who is not using adequate contraceptive precautions - Subject has any kind of disorder that compromises the ability of the subject to give written informed consent and/or to comply with study procedures

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cancer

Intervention

Drug:
• darbepoetin alfa

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Amgen

References & Publications (1)

Bastit L, Vandebroek A, Altintas S, Gaede B, Pintér T, Suto TS, Mossman TW, Smith KE, Vansteenkiste JF. Randomized, multicenter, controlled trial comparing the efficacy and safety of darbepoetin alpha administered every 3 weeks with or without intravenous — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of subjects achieving a hematopoietic response (hemoglobin [hgb] greater than or equal to 12 g/dL or rise in hgb of greater than 2 g/dL) during the treatment period
Secondary	Time to hematopoietic response in days
Secondary	The proportion of subjects with at least one red blood cell (RBC) transfusion from week 5 (day 29) to end of treatment period (EOTP)
Secondary	Change in hemoglobin from baseline to EOTP
Secondary	The proportion of subjects achieving a hemoglobin concentration greater than or equal to 11.0 g/dL, in the absence of RBC transfusions in the preceding 28 days, from week 5 to EOTP
Secondary	The average hgb after achieving a hgb level greater than or equal to 11.0 g/dL
Secondary	Patient reported outcomes: Change in Functional Assessment of Cancer Therapy (FACT)-Fatigue subscale score from baseline to EOTP
Secondary	Change in FACT-G Physical Well-being subscale from baseline to EOTP
Secondary	Change in FACT-G total score from baseline to EOTP
Secondary	Change in EuroQoL (EQ-5D) thermometer and ED-5D scores from baseline to EOTP

External Links

•   AmgenTrials clinical trials website
•   FDA-approved Drug Labeling