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Sponsored by: |
Affymax |
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Information provided by: | Affymax |
ClinicalTrials.gov Identifier: | NCT00272662 |
The purpose of this study is to evaluate the safety, pharmacodynamics (PD), and pharmacokinetics (PK) of multiple subcutaneously administered injections of Hematide™ in anemic cancer patients receiving chemotherapy.
Condition | Intervention | Phase |
---|---|---|
Chemotherapy Induced Anemia Cancer |
Drug: Hematide™ |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Phase 2, Open-Label, Multi-Center Dose Escalation Study of the Safety, Pharmacodynamics, and Pharmacokinetics of Subcutaneously Administered Hematide™ in Anemic Cancer Patients Receiving Chemotherapy |
Estimated Enrollment: | 90 |
Study Start Date: | December 2005 |
Estimated Study Completion Date: | September 2008 |
Estimated Primary Completion Date: | September 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
I: No Intervention |
Drug: Hematide™
Injection
|
II: No Intervention |
Drug: Hematide™
Injection
|
Ages Eligible for Study: | 18 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
If the patient is considered by the Investigator as iron-deficient and IV iron supplementation is required, patient must be re-screened weekly (no sooner than 7 days after iron administration) until hemoglobin has not increased more than 0.5 g/dL from the previous week.*
Exclusion Criteria:
Czech Republic | |
Research Facility | |
Brno, Czech Republic | |
Research Facility | |
Olomouc, Czech Republic | |
Research Facility | |
Hradec Kralove, Czech Republic | |
Research Facility | |
Pribram, Czech Republic, 261 01 | |
Research Facility | |
Praha 2, Czech Republic, 128 08 | |
Poland | |
Research Facility | |
Poznań, Poland | |
Research Facility | |
Szczecin, Poland | |
Research Facility | |
Opole, Poland | |
Research Facility | |
Krakow, Poland | |
Research Faciliy | |
Gdańsk, Poland | |
Research Facility | |
Krakow, Poland, 31-826 | |
Research Facility | |
Ul. Okolna 181, Poland, 91-520 Lodz | |
Research Facility | |
Warszawa, Poland, 00-909 | |
United Kingdom | |
Research Facility | |
London, United Kingdom | |
Research Facility | |
Manchester, United Kingdom |
Study Director: | Chief Medical Officer | Affymax, Inc |
Responsible Party: | Affymax, Inc. ( Chief Medical Officer ) |
Study ID Numbers: | AFX01-05 |
Study First Received: | January 5, 2006 |
Last Updated: | April 28, 2008 |
ClinicalTrials.gov Identifier: | NCT00272662 |
Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency |
Anemia cancer hemoglobin Anemia in cancer patients |
Hematologic Diseases Anemia |