Treatment for Anemic Subjects With Non-Myeloid Malignancies Receiving Chemotherapy

NCT ID: NCT00120705

Last Updated: 2009-03-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 204 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-11-30
• Study Completion Date: 2003-09-30

Brief Summary

The purpose of this study is to assess the ability of darbepoetin alfa to maintain hemoglobin concentrations greater than or equal to 10 g/dL when administered every 3 weeks (Q3W).

Conditions

Neoplasms; Anemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

darbepoetin alfa

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

Inclusion Criteria: - Subjects with non-myeloid malignancies - Anemia (screening hemoglobin concentration greater than or equal to 10.5 g/dL but less than or equal to 12.0 g/dL) related to cancer and chemotherapy - At least 8 additional weeks of cyclic chemotherapy planned regardless of schedule - Karnofsky Performance Status of greater than or equal to 50% - Serum creatinine concentration less than or equal to 2.

Exclusion Criteria

0 mg/dL Exclusion Criteria: - Iron deficiency - Red blood cell (RBC) transfusion within 4 weeks of screening - Unstable cardiac disease

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Amgen

INDUSTRY

Sponsor Role: lead

Responsible Party

Amgen Inc.

Principal Investigators

MD

Role: STUDY_DIRECTOR

Amgen

References

Charu V, Saidman B, Ben-Jacob A, Justice GR, Maniam AS, Tomita D, Rossi G, Rearden T, Glaspy J. A randomized, open-label, multicenter trial of immediate versus delayed intervention with darbepoetin alfa for chemotherapy-induced anemia. Oncologist. 2007 Oct;12(10):1253-63. doi: 10.1634/theoncologist.12-10-1253.

Reference Type: RESULT

PMID: 17962619 (View on PubMed)

Related Links

http://www.amgentrials.com

AmgenTrials clinical trials website

Other Identifiers

20020167

Identifier Type: -

Identifier Source: org_study_id