A Study of Darbepoetin Alfa for the Treatment of Anemia in Subjects With Non-Myeloid Malignancy Receiving Multicycle Chemotherapy

NCT00118638 | Completed Phase 3

• 1 other identifier: 20030231
• Study Type: interventional
• Target: 705
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to evaluate the efficacy of darbepoetin alfa as 500ug once every 3 weeks to show that the dose and schedule are not inferior to darbepoetin alfa administered as 2.25ug/kg once per week in the treatment of anemia in subjects with non-myeloid malignancies.

Conditions

Anemia; Non-Myeloid Malignancies

Keywords

Non-myeloid malignancy; Darbepoetin alfa; Clinical Trial

Outcome Measures

Primary Outcomes (1)

• Incidence of at least one RBC transfusion from week 5 to End of Treatment Period (EOTP)

  from week 5 to EOTP

Secondary Outcomes (16)

• Incidence of achieving a hemoglobin concentration of 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

  from week 5 to EOTP

• Incidence of at least one RBC transfusion from week 1 (day 1) to EOTP

  from week 1 (day 1) to EOTP

• Incidence of 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 1 to EOTP

  from week 1 to EOTP

• Change in FACT-G Physical Well-being subscale from baseline to EOTP

  from baseline to EOTP

• Change in hemoglobin from baseline to EOTP

  from baseline to EOTP

Study Arms (2)

Darbepoetin alfa 500 mcg - Group A

EXPERIMENTAL

Drug: Darbepoetin alfa - 500mcg

Darbepoetin alfa 2.25 mcg/kg - Group B

ACTIVE COMPARATOR

Drug: Darbepoetin alfa - 2.25 mcg/kg

Interventions

Darbepoetin alfa - 2.25 mcg/kg DRUG

Darbepoetin alfa 2.25 mcg/kg QW dosing/ placebo Q3W

Darbepoetin alfa 2.25 mcg/kg - Group B

Darbepoetin alfa - 500mcg DRUG

Darbepoetin alfa 500mcg Q3W dosing / placebo QW

Darbepoetin alfa 500 mcg - Group A

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Non-myeloid malignancy
• At least 12 additional weeks of cyclic cytotoxic chemotherapy anticipated regardless of schedule
• Eastern Cooperative Oncology Group performance status of 0-2
• Hemoglobin concentration of less than 11 g/dL within 24 hours before randomization
• Of legal age at the time written informed consent is obtained

You may not qualify if:

• Known history of seizure disorder
• Known primary hematologic disorder, which could cause anemia, other than a non-myeloid malignancy
• Unstable or uncontrolled disease/condition, related to or affecting cardiac function
• Clinically significant inflammatory disease
• Inadequate renal and/or liver function
• Known positive HIV test
• Previously suspected of or confirmed to have neutralizing antibodies to rHuEPO
• Received more than 2 red blood cell (RBC) transfusions within 4 weeks before randomization or any RBC transfusion within 14 days before randomization, or any planned RBC 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
• Other investigational procedures
• Subject is currently enrolled in or less than 30 days since receipt of any investigational drug or device that is not approved by the applicable regulatory authority
• Pregnant or breast feeding
• Not using adequate contraceptive precautions
• Known sensitivity to any of the products to be administered during dosing
• Previously randomized in this study

Sponsors & Collaborators

• Amgen: lead

Related Publications (4)

• Canon JL, Vansteenkiste J, Hedenus M, Gascon P, Bokemeyer C, Ludwig H, Vermorken J, Legg J, Pujol B,

  BACKGROUND

• Canon JL, Vansteenkiste J, Hedenus M, Gascon P, Bokemeyer C, Ludwig H, Vermorken J, Legg J, Pujol B, Bridges K. Transfusion risk in cancer patients with chemotherapy-induced anemia when initiating darbepoetin alfa therapy at a baseline hemoglobin level of <9 g/dL versus 9 to <10 g/dL versus >/= 10 g/dL: an exploratory analysis of a phase 3 trial. Med Oncol. 2012 Sep;29(3):2291-9. doi: 10.1007/s12032-011-0103-x. Epub 2011 Nov 13.

  PMID: 22081263 RESULT

• Canon JL, Vansteenkiste J, Bodoky G, Mateos MV, Bastit L, Ferreira I, Rossi G, Amado RG. Randomized, double-blind, active-controlled trial of every-3-week darbepoetin alfa for the treatment of chemotherapy-induced anemia. J Natl Cancer Inst. 2006 Feb 15;98(4):273-84. doi: 10.1093/jnci/djj053.

  PMID: 16478746 RESULT

• Vansteenkiste J, Hedenus M, Gascon P, Bokemeyer C, Ludwig H, Vermorken J, Hamilton L, Bridges K, Pujol B. Darbepoetin alfa for treating chemotherapy-induced anemia in patients with a baseline hemoglobin level < 10 g/dL versus > or = 10 g/dL: an exploratory analysis from a randomized, double-blind, active-controlled trial. BMC Cancer. 2009 Sep 3;9:311. doi: 10.1186/1471-2407-9-311.

  PMID: 19728887 RESULT

Related Links

• AmgenTrials clinical trials website
• Notice regarding posted summaries of trial results
• To access clinical trial results information click on this link
• FDA-approved Drug Labeling

MeSH Terms

Conditions

Anemia

Interventions

Darbepoetin alfa

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Erythropoietin; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Proteins; Amino Acids, Peptides, and Proteins

Study Officials

• MD

  Amgen

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 30, 2005
• First Posted: July 12, 2005
• Study Start: March 1, 2004
• Primary Completion: December 1, 2004
• Study Completion: January 1, 2005
• Last Updated: April 29, 2013

Record last verified: 2013-04