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 - AIM 3: Anemia and Iron Management with every 3 week dosing

Phase 1

• Conditions: Chemotherapy induced anemia; MedDRA version: 7.0Level: PTClassification code 10049105

• Registration Number: EUCTR2004-001417-33-CZ
• Lead Sponsor: Amgen Inc

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2004-12-03
• Study Completion: 2006-08-01
• Last Update Posted: 4 January 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

- subjects with non-myeloid malignancy (Chronic Myeloid Leukemia [CML], acute leukemia [AML & 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 < 11 g/dL within 24 hours before randomization
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
- of legal age at the time written informed consent is obtained
- written informed consent must be obtained from the subject or legally accepted representative before any study-specific-procedure, including screening procedures, is performed
Are the trial subjects under 18?
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

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 (eg, 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 (eg, unstable angina, congestive heart failure, uncontrolled hypertension and/or unstable cardiac arrhythmia)
- chronic inflammatory disease that is not stable (eg, rheumatoid arthritis, Crohn’s disease, peptic ulcer, ulcerative disease, etc)
- active bleeding
- clinically significant systemic infection
- inadequate renal and/or liver function (creatinine >2X ULN and /or transaminases >5X ULN)
- nutritional deficiency (defined as serum folate < 4.5 nmol/L (< 2.0 ng/mL) or vitamin B12 <148 pmol/L (< 200 pg/mL))
- iron deficiency (transferrin saturation < 15% and serum ferritin < 10 ng/mL. (Subjects must have both to be excluded.)
- serum ferritin > 800 ng/mL (patients with serum ferritin > 500 ng/mL may only be enrolled if transferring saturation < 30%)
- known sensitivity to iron administration
- known (documented in medical records) positive HIV test
- previously suspected of or confirmed (documented in medical records) to have neutralizing antibodies to rHuEPO (eg, reasons to suspect including prolonged lack of response to previous erythropoietin therapy, pure red cell aplasia, inexplicably low reticulocyte counts following previous erythropoietin therapy, or other clinical evidence in the judgment of the investigator)
- 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 of randomization or any planned erythropoietic therapy between randomization and study day 1.
- other investigational procedures
- less than 30 days since receipt of any investigational drug or device (administered/used as part of an investigational study) that is not approved by the applicable regulatory authority (with the exception of Thalidomide)
- subject of reproductive potential is evidently pregnant (eg, positive serum HCG test) or is breast feeding
- subject of reproductive potential who is not using adequate contraceptive precautions
- subject has known sensitivity to any of the products to be administered during dosing.
- subject was previously randomized in this study
- 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

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To compare hematopoietic response after 16 weeks of treatment with 500 mcg once every 3 weeks (Q3W) darbepoetin alfa and either IV iron or following standard practice (oral iron or no iron supplementation).;Secondary Objective: Compare:<br>- impact on the time to hematopoietic response of 16 weeks of treatment with 500 mcg Q3W darbepoetin alfa with either IV iron or following standard practice.<br>- impact on RBC transfusions of 16 weeks of treatment with 500 mcg Q3W darbepoetin alfa with either IV iron or following standard practice.<br>- impact on change in hemoglobin of 16 weeks of treatment with 500 mcg Q3W darbepoetin alfa with either IV iron or following standard practice.<br>- assess safety of 500 mcg darbepoetin alfa administered Q3W administered via the auto-injector with IV iron or following standard practice.;Primary end point(s): The proportion of subjects achieving a hematopoietic response (hgb > 12 g/dl or rise in hgb of > 2 g/dl) during the treatment period.