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

A Randomized, Double Blind, Active-Controlled Study of Darbepoetin Alfa for the Treatment of Anemia in Subjects With Non-Myeloid Malignancy Receiving Multicycle Chemotherapy

Sponsors

Lead Sponsor: Amgen

Source

Amgen

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.

Overall Status

Completed

Start Date

March 2004

Completion Date

January 2005

Primary Completion Date

December 2004

Phase

Phase 3

Study Type

Interventional

Primary Outcome

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

Secondary Outcome

Measure	Time Frame
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
Change in FACT-Fatigue subscale score from baseline to EOTP	from baseline to EOTP
Change in FACT-G total score from baseline to EOTP	from baseline to EOTP
Change in EQ-5D Thermometer from baseline to EOTP	from baseline to EOTP
Change in BSI Anxiety scale score from baseline to EOTP	from baseline to EOTP
Change in BSI Depression scale score from baseline to EOTP	from baseline to EOTP
Incidence and severity of adverse events	throughout study
Incidence of hemoglobin concentration greater than 13.0 g/dL at any time on study	at any time on study
Change in number of caregiver hours from baseline to EOTP	from baseline to EOTP
Incidence of an increase in hemoglobin concentration greater than or equal to 2 g/dL in a 28-day window and any negative clinical consequences	throughout study
Incidence of an increase in hemoglobin concentration of greater than or equal to 1 g/dL in a 14-day window and any negative clinical consequences	throughout study
Incidence of a confirmed antibody formation to darbepoetin alfa	throughout study

Enrollment

705

Condition

Intervention

Intervention Type: Drug

Intervention Name: Darbepoetin alfa - 2.25 mcg/kg

Description: Darbepoetin alfa 2.25 mcg/kg QW dosing/ placebo Q3W

Arm Group Label: Darbepoetin alfa 2.25 mcg/kg - Group B

Intervention Type: Drug

Intervention Name: Darbepoetin alfa - 500mcg

Description: Darbepoetin alfa 500mcg Q3W dosing / placebo QW

Arm Group Label: Darbepoetin alfa 500 mcg - Group A

Eligibility

Criteria:

Inclusion Criteria:

- 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

Exclusion Criteria:

- 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

- Concerns for subject's compliance with protocol procedures

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Overall Official

Last Name	Role	Affiliation
MD	Study Director	Amgen

Verification Date

April 2013

Responsible Party

Type: Sponsor

Keywords

Has Expanded Access

Condition Browse

Number Of Arms

Arm Group

Label: Darbepoetin alfa 500 mcg - Group A

Type: Experimental

Label: Darbepoetin alfa 2.25 mcg/kg - Group B

Type: Active Comparator

Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Source: ClinicalTrials.gov