- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00036023
Chemotherapy Related Anemia in Patients With Non-Myeloid Malignancies
May 7, 2009 updated by: Amgen
A Randomized, Open-Label, Dose-Timing Study of Darbepoetin Alfa Administered Once Every 3 Weeks (Q3W) by Subcutaneous (SC) Injection for Treatment of Anemia in Subjects With Non-Myeloid Malignancies Receiving Multicycle Chemotherapy
Chemotherapy can often cause anemia in patients with cancer.
Anemia is a low number of red blood cells.
The symptoms of anemia may include fatigue, dizziness, headache, chest pain, and shortness of breath.
Erythropoietin is a hormone made by the kidneys that signals the bone marrow to produce more red blood cells.
Recombinant human erythropoietin has been produced in the laboratory and has the same effect as the hormone produced by the body.
Use of recombinant human erythropoietin allows the body to produce more red blood cells, possibly eliminating or decreasing your symptoms and the need for a red blood cell transfusion.
Recombinant human erythropoietin is FDA approved to treat anemia in cancer patients receiving chemotherapy.
This clinical study is investigating the effectiveness of darbepoetin alfa for the treatment of anemia in patients with non-myeloid malignancies who are receiving chemotherapy every three weeks.
Darbepoetin alfa is a recombinant erythropoietic protein that stimulates the production of red blood cells.
This medication has not been approved to treat cancer patients with anemia, however it has been approved by the FDA to treat chronic renal failure patients with anemia.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Phase
- Phase 2
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
- Patients with non-myeloid malignancies * Patients receiving at least 12 weeks of chemotherapy on a 3-week cycle schedule * Patients with anemia (hgb >/= 9.0 and </= 11.0 g/dL)
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: None (Open Label)
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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.
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 Registration Dates
First Submitted
May 7, 2002
First Submitted That Met QC Criteria
May 7, 2002
First Posted (Estimate)
May 8, 2002
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
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Skin Diseases
- Respiratory Tract Diseases
- Immune System Diseases
- Neoplasms by Histologic Type
- Lymphoproliferative Disorders
- Lymphatic Diseases
- Immunoproliferative Disorders
- Lung Diseases
- Neoplasms by Site
- Hematologic Diseases
- Breast Diseases
- Hemorrhagic Disorders
- Respiratory Tract Neoplasms
- Thoracic Neoplasms
- Hemostatic Disorders
- Paraproteinemias
- Blood Protein Disorders
- Neoplasms, Plasma Cell
- Leukemia, Lymphoid
- Leukemia
- Leukemia, B-Cell
- Neoplasms
- Breast Neoplasms
- Lung Neoplasms
- Multiple Myeloma
- Leukemia, Lymphocytic, Chronic, B-Cell
- Hematinics
- Darbepoetin alfa
Other Study ID Numbers
- 20010162
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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