Treatment of Anemia in Subjects With Non-Myeloid Malignancy Receiving Multicycle Chemotherapy

• Sponsor: Amgen (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00110955
• Collaborator: (none)
• Enrollment: 391
• Arms: 2
• Duration (Months): 14

Study Details

Study Description

Brief Summary

The purpose of this study is to compare the effect of darbepoetin alfa against placebo for the treatment of anemia in subjects with non-myeloid malignancies receiving multicycle chemotherapy.

Condition or Disease	Intervention/Treatment	Phase
Anemia; Non-Myeloid Malignancies	Drug: Darbepoetin alfa; Drug: Placebo	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 391 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Randomized, Double-Blind, Placebo-Controlled Study of Darbepoetin Alfa for the Treatment of Anemia in Subjects With Non-Myeloid Malignancy Receiving Multicycle Chemotherapy
• Study Start Date: Feb 1, 2004
• Actual Primary Completion Date: Mar 1, 2005
• Actual Study Completion Date: Apr 1, 2005

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Darbepoetin alfa - Group A	Drug: Darbepoetin alfa; Q3W 300 mcg darbepoetin alfa
Placebo Comparator: Placebo- Group B	Drug: Placebo; Q3W dosing of placebo

Outcome Measures

Primary Outcome Measures

1. Incidence of red blood cell (RBC) transfusion from week 5 to End of Treatment Period (EOTP) [from week 5 to EOTP]

Secondary Outcome Measures

1. Incidence of achieving a hemoglobin concentration of greater than or equal to 11 g/dL in the absence of RBC transfusions in the preceding 28 days from week 5 to EOTP [from week 5 to EOTP]

2. Number of RBC transfusions from week 5 to EOTP [from week 5 to EOTP]

3. Change in FACT-Fatigue subscale score from baseline to EOTP [from baseline to EOTP]

4. Change in FACT-G Physical Well-being subscale from baseline to EOTP [from baseline to EOTP]

5. Incidence and severity of adverse events [throughout study]

6. Incidence of hemoglobin concentration greater than 13.0 g/dL at any time on study [at any time on study]

7. Change in FACT-G total score from baseline to EOTP [from baseline to EOTP]

8. 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]

9. Change in EQ-5D Thermometer from baseline to EOTP [from baseline to EOTP]

10. Change in BSI Anxiety scale score from baseline to EOTP [from baseline to EOTP]

11. Change in BSI Depression scale score from baseline to EOTP [from baseline to EOTP]

12. Change in number of caregiver hours from baseline to EOTP [from baseline to EOTP]

13. Incidence of a confirmed antibody formation to darbepoetin alfa [throughout study]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Subjects with non-myeloid malignancy

• At least 12 additional weeks of cyclic cytotoxic chemotherapy anticipated regardless of schedule

• Hemoglobin concentration less than 11.0 g/dL within 24 hours before randomization

• Adequate serum folate and vitamin B12

• Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2

• Of legal age at the time written informed consent is obtained

Exclusion Criteria:

• Known history of seizure disorder

• Known primary hematologic disorder causing anemia other than non-myeloid malignancies

• Unstable/uncontrolled cardiac condition

• Clinically significant inflammatory disease

• Other diagnoses not related to the cancer which can cause anemia

• Inadequate renal and liver function

• Iron deficiency

• Known positive test for HIV infection

• Previously suspected of or confirmed to have neutralizing antibodies to rHuEPO

• Received more than 2 red blood cell (RBC) transfusions within 4 weeks of 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 of study day 1 or any planned erythropoietic therapy between randomization and study day 1

• Other investigational procedures

• Currently enrolled in or has not yet completed at least 30 days since ending other investigational device or drug trial(s), or subject receiving other investigational agent(s)

• Pregnant or breast feeding

• Not using adequate contraceptive precautions

• Previously randomized into this study

• Known hypersensitivity to any products to be administered

• Concerns for subject's compliance

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Amgen

Investigators

• Study Director: MD, Amgen

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• 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

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00110955
• Other Study ID Numbers: 20030232
• First Posted: May 17, 2005
• Last Update Posted: Jan 15, 2010
• Last Verified: Jan 1, 2010

• Keywords provided by , ,: Non-myeloid malignancy; Chemotherapy-induced anemia
• Additional relevant MeSH terms: Neoplasms; Anemia; Darbepoetin alfa

Study Results

No Results Posted as of Jan 15, 2010