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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


Phase 3
18 Years
N/A
Not Enrolling
Both
Cancer

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

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

Principal Investigator

MD

Investigator Role:

Study Director

Investigator Affiliation:

Amgen

Authority:

Germany: Federal Institute for Drugs and Medical Devices

Study ID:

20040156

NCT ID:

NCT00135317

Start Date:

November 2004

Completion Date:

Related Keywords:

  • Cancer
  • oncology
  • darbepoetin alfa
  • Aranesp®
  • Amgen
  • Non-myeloid malignancy
  • Neoplasms

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