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Once Per Cycle Treatment of Anemia With Darbepoetin Alfa With Iron in Subjects With Non Myeloid Malignancies

Phase 2
18 Years
Not Enrolling
Anemia, Non-Myeloid Malignancies

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Trial Information

Once Per Cycle Treatment of Anemia With Darbepoetin Alfa With Iron in Subjects With Non Myeloid Malignancies

Inclusion Criteria:

- Subjects with active non myeloid malignancy(cies) including lymphocytic leukemias

- Received chemotherapy and expected to receive at least 8 additional weeks of cyclic
cytotoxic chemotherapy

- Anemia due to chemotherapy (screening Hgb
- at least 18 years of age at screening

Exclusion Criteria:

- Subjects with acute myelogenous leukemia (AML), chronic myelogenous leukemia (CML),
or myelodysplastic syndromes (MDS)

- Other underlying hematologic disorder, which could cause anemia, other than a non
myeloid malignancy

- Active bleeding

- Severe, unstable, active chronic inflammatory disease (eg ulcerative disease, peptic
ulcer disease, rheumatoid arthritis)

- Active, unstable systemic or chronic infection

- Planned elective surgery during the study where significant blood loss is expected

- Unstable angina, or uncontrolled cardiac arrhythmia

- Uncontrolled hypertension (diastolic blood pressure > 100 mmHg)

- History of pure red cell aplasia (PRCA)

- History of deep venous thrombosis

- Known positive human immunodeficiency virus (HIV) test or acquired immune deficiency
syndrome (AIDS) status

- Any RBC transfusion within 28 days before randomization and/or during screening

- Subjects currently receiving thalidomide or lenalidomide without prophylactic
anticoagulant therapy

- Subjects currently receiving or planned to receive myeloablative radiation therapy

- Subjects who have received bone marrow or stem cell transplant in the 6 months prior
to screening or planned during the study

- Received any erythropoietic therapy within 28 days before randomization and/or during
screening (eg rHuEPO or darbepoetin alfa)

- Subject has known sensitivity to any erythropoietic agents, the investigational
product or its excipients to be administered during this study

- Subject has known sensitivity to iron administration

- Subjects who are pregnant or breast feeding

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

The proportion of subjects who achieve the target hemoglobin (Hgb 11 g/dL) during the treatment period in the absence of a RBC transfusion within the prior 28 days

Outcome Time Frame:

3 months

Safety Issue:


Principal Investigator


Investigator Role:

Study Director

Investigator Affiliation:



Romania: Ministry of Health and the Family

Study ID:




Start Date:

December 2006

Completion Date:

March 2008

Related Keywords:

  • Anemia
  • Non-Myeloid Malignancies
  • anemia
  • chemotherapy induced anemia
  • darbepoetin alfa
  • cancer
  • Anemia
  • Neoplasms