Spots Global Cancer Trial Database for A Safety and Tolerability Study of Peginesatide in Anemic Cancer Patients Receiving Cytotoxic Chemotherapy.

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Trial Identification

Brief Title: A Safety and Tolerability Study of Peginesatide in Anemic Cancer Patients Receiving Cytotoxic Chemotherapy.

Official Title: A Phase 1, Multicenter, Open-Label Dose Escalation Study Evaluating the Safety and Tolerability of Multiple Hematide Injections in Subjects With Refractory Non-Small Cell Lung Cancer, Breast Cancer, or Prostate Cancer Who Are Anemic and Receiving Cytotoxic Chemotherapy

Study ID: NCT00629876

Conditions

Anemia

Interventions

Peginesatide

Study Description

Brief Summary: The purpose of this study is to determine the safety and tolerability of peginesatide used to treat anemia in subjects diagnosed with recurrent non-small cell lung cancer, breast cancer or prostate cancer and who also receiving a taxane chemotherapy.

Detailed Description: Currently approved erythropoiesis stimulating agents have been used successfully to increase hemoglobin levels, reduce fatigue and other anemia-related symptoms, improve daily function, and alleviate the need for transfusions of red blood cells in subjects with chronic kidney disease-related anemia or in cancer subjects with chemotherapy-induced anemia. Peginesatide (hematide) Injection is a parenteral formulation for administration by intravenous or subcutaneous injection that is being developed for the correction of anemia in patients with chronic kidney disease, including patients on dialysis and patients not on dialysis, and for the treatment of patients with anemia due to concomitantly administered chemotherapy. This is a multicenter, open-label dose escalation study to evaluate the safety, tolerability, and efficacy of multiple doses of peginesatide Injection in subjects with refractory non-small cell lung cancer, breast cancer, or prostate cancer. These subjects must have anemia diagnosed as a result of taxane chemotherapy.