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An Open-label, Randomized Study to Develop a Screening Tool for Functional Capacity in Anemic Subjects With Nonmyeloid Malignancies Receiving Chemotherapy and Darbepoetin Alfa (NESP)


Phase 2
18 Years
N/A
Not Enrolling
Both
Anemia, Non-Myeloid Malignancies

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Trial Information

An Open-label, Randomized Study to Develop a Screening Tool for Functional Capacity in Anemic Subjects With Nonmyeloid Malignancies Receiving Chemotherapy and Darbepoetin Alfa (NESP)


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Proportion of subjects whose baseline score on the subjective FCST correctly estimates the baseline MHST score

Outcome Time Frame:

baseline

Safety Issue:

No

Principal Investigator

MD

Investigator Role:

Study Director

Investigator Affiliation:

Amgen

Authority:

United States: Food and Drug Administration

Study ID:

20000220

NCT ID:

NCT00540696

Start Date:

September 2001

Completion Date:

September 2003

Related Keywords:

  • Anemia
  • Non-Myeloid Malignancies
  • Anemia
  • Non-Myeloid Malignancies
  • darbepoetin alfa
  • chemotherapy
  • Anemia
  • Neoplasms

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