A Study of Darbepoetin Alfa in Anemic Subjects Not Receiving Chemotherapy Who Have Completed the 20010103 Study

May 7, 2009 updated by: Amgen

A Multicenter, Randomised, Double-Blind, Placebo-Controlled Roll Over Study to Protocol 20010103 of Darbepoetin Alfa for the Treatment of Anemia of Cancer

The purpose of this study is to determine the safety of darbepoetin alfa beyond 16 weeks of treatment in subjects with anemia of cancer who are not receiving chemotherapy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

371

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

- Subjects completing the planned 16 weeks of treatment on the 20010103 Anemia of Cancer protocol

Exclusion Criteria:

  • Subjects currently receiving or planned to receive cytotoxic chemotherapy or myelosuppressive radiotherapy
  • Subjects who have other diagnoses not related to the cancer which can cause anemia
  • Known history of seizure disorder
  • Cardiac condition: uncontrolled angina, congestive heart failure, known ejection fraction less than 40%, or uncontrolled cardiac arrhythmia
  • Uncontrolled hypertension
  • Clinically significant systemic infection or chronic inflammatory disease present at the time of enrollment
  • Subject of reproductive potential who is not using adequate contraceptive precautions
  • Concerns for subject's compliance with the protocol procedures

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
Q4W
Experimental: Darbepoetin alfa
Drug: Darbepoetin alfa
Q4W

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of adverse events
Time Frame: throughout study
throughout study

Secondary Outcome Measures

Outcome Measure
Time Frame
Confirmed antibody formation to investigational product
Time Frame: throughout study
throughout study
Deaths on study
Time Frame: on study
on study
Laboratory parameters
Time Frame: throughout study
throughout study
Vital signs (blood pressure)
Time Frame: throughout study
throughout study
Change in PRO scores
Time Frame: from baseline to end of treatment
from baseline to end of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Amgen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2004

Primary Completion (Actual)

January 1, 2007

Study Completion (Actual)

March 1, 2007

Study Registration Dates

First Submitted

June 21, 2005

First Submitted That Met QC Criteria

June 21, 2005

First Posted (Estimate)

June 22, 2005

Study Record Updates

Last Update Posted (Estimate)

May 11, 2009

Last Update Submitted That Met QC Criteria

May 7, 2009

Last Verified

May 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20020149

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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