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

This study has been completed.
Sponsor:
Information provided by:
Amgen
ClinicalTrials.gov Identifier:
NCT00540696
First received: October 4, 2007
Last updated: April 24, 2013
Last verified: April 2013
  Purpose

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.


Condition Intervention Phase
Anemia
Non-Myeloid Malignancies
Drug: darbepoetin alfa
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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)

Resource links provided by NLM:


Further study details as provided by Amgen:

Primary Outcome Measures:
  • Proportion of subjects whose baseline score on the subjective FCST correctly estimates the baseline MHST score [ Time Frame: baseline ] [ Designated as safety issue: No ]
  • Relationship between hemoglobin (hgb) response and change in functional capacity [ Time Frame: week 1, week 9, week 17 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Estimates of the sensitivity and specificity of the FCST [ Designated as safety issue: No ]
  • Relationship between hgb variables and changes on the MHST score, the FCST and its components [ Time Frame: from baseline to end of treatment phase ] [ Designated as safety issue: No ]
  • Maximum change in hgb from baseline to any point during the study, excluding hgb measurements obtained within 28 days of a red blood cell (RBC) transfusion [ Time Frame: from baseline to any point during the study ] [ Designated as safety issue: No ]
  • Number and proportion of subjects who achieve a hgb response as defined by an increase of greater than or equal to 2.0 g/dL from the baseline hgb in absence of any RBC transfusion within the prior 28 days at any point during the study (hgb response) [ Time Frame: from baseline to any point during the study ] [ Designated as safety issue: No ]
  • Hgb improvement (defined as correction and/or response) [ Time Frame: from baseline to any point during the study ] [ Designated as safety issue: No ]
  • Change in hgb from baseline to week 17, or the subject's last hgb value excluding hgb measurements obtained within 28 days of a RBC transfusion [ Time Frame: from baseline to week 17 ] [ Designated as safety issue: No ]
  • Number and proportion of subjects who receive any RBC transfusions, the number of units of RBC transfused, and the number of days with at least 1 RBC transfusion from weeks 1 to end of treatment phase, weeks 1 to 4, and weeks 5 to end of treatment phase [ Time Frame: from weeks 1 to end of treatment phase, weeks 1 to 4, and weeks 5 to end of treatment phase ] [ Designated as safety issue: No ]
  • Safety of this dosing regimen of darbepoetin alfa by incidence of clinical adverse events [ Time Frame: throughout the study ] [ Designated as safety issue: Yes ]
  • Safety of darbepoetin alfa as determined by antibody formation [ Time Frame: throughout the study ] [ Designated as safety issue: Yes ]
  • Changes in concomitant medications [ Time Frame: throughout the study ] [ Designated as safety issue: Yes ]
  • Rapid rise in hgb (a greater than or equal to 2.0 g/dL increase in hgb concentration within a 28-day window during the treatment period) [ Time Frame: within a 28-day window during the treatment period ] [ Designated as safety issue: Yes ]
  • Proportion of subjects who achieve a hgb of greater than or equal to 12.0 g/dL at any point during the study (hgb correction) [ Time Frame: at any point during the study ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 300
Study Start Date: September 2001
Study Completion Date: September 2003
Primary Completion Date: June 2003 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: darbepoetin alfa Drug: darbepoetin alfa

Darbepoetin alfa 3.0mcg/kg every 2 weeks for 3 doses. At week 7, if the subject has not experienced an increase of at least 1.0g/dL in hgb from week 1, increase dose of darbepoetin alfa to 5.0mcg/kg every 2 weeks for 5 doses.

Otherwise, maintain darbepoetin alfa 3.0mcg/kg every 2 weeks for 5 doses.


  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00540696

Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen
  More Information

Additional Information:
Publications:
Responsible Party: Global Development Leader, Amgen Inc.
ClinicalTrials.gov Identifier: NCT00540696     History of Changes
Other Study ID Numbers: 20000220
Study First Received: October 4, 2007
Last Updated: April 24, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Amgen:
Anemia
Non-Myeloid Malignancies
darbepoetin alfa
chemotherapy

Additional relevant MeSH terms:
Anemia
Neoplasms
Hematologic Diseases
Darbepoetin alfa
Hematinics
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 20, 2014