Study to Develop a Screening Tool for Functional Capacity in Anemic Subjects With Nonmyeloid Malignancies Receiving Chemotherapy and Darbepoetin Alfa

Amgen

Status and phase: Completed; Phase 2

Conditions: Anemia; Non-Myeloid Malignancies

Treatments: Drug: darbepoetin alfa

Study type: Interventional

Funder types: Industry

Identifiers

NCT00540696

20000220

Details and patient eligibility

About

The purpose of this study is to develop a functional capacity screening tool (FCST) that estimates at baseline the functional capacity of anemic subjects with nonmyeloid malignancies receiving multicycle chemotherapy.

Sites will be randomly assigned in 1:1 ratio to 1 of 2 different subject-reported functional capacity questionnaires. The questionnaires will be used to develop the FCST. Subjects will participate in the Modified Harvard Step Test (MHST) at required timepoints and receive darbepoetin alfa once every 2 weeks for 15 weeks. All subjects will return for a follow-up visit 2 weeks after the last dose of darbepoetin alfa.

Enrollment: 300 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Non-myeloid malignancies
• Anemia (hgb less than or equal to 11.0 g/dL) related to cancer and chemotherapy
• Plan to receive cyclic chemotherapy for an additional 8 weeks
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
• Adequate renal and liver function
• Ability to participate in the MHST based on clinical judgement of investigator
• At least 18 years of age

Exclusion criteria

• Iron deficiency
• Received recombinant human erythropoietin (rHuEPO) therapy within 4 weeks prior to enrollment
• Unstable cardiac disease
• Current active condition creating clinical danger for the subject to participate in the MHST
• known positive test for HIV infection
• Previous hematologic disorder associated with anemia
• Currently receiving beta-blockers
• Use of drugs or devices not approved by the FDA for any indication
• Pregnant or breast feeding
• Known hypersensitivity to any recombinant mammalian-derived product

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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300 participants in 1 patient group

darbepoetin alfa

Experimental group

Treatment:

Drug: darbepoetin alfa