A Safety and Tolerability Study of Peginesatide in Anemic Cancer Patients Receiving Cytotoxic Chemotherapy.
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|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|
- Maximum tolerated dose. [ Time Frame: End of Treatment. ]
- Proportion of subjects who have 2 consecutive Hgb values of either an increase of ≥1 g/dL or a Hgb ≥11 g/dL in the absence of a red blood cell transfusion. [ Time Frame: At All Visits for every cycle. ]
- Proportion of subjects who have an increase in Hgb of ≥1 g/dL or a Hgb ≥11 g/dL in the absence of a red blood cell transfusion. [ Time Frame: Days 22 and 43 for every cycle. ]
- Proportion of subjects with 2 consecutive Hgb values increase of ≥1 g/dL or ≥11 g/dL during the Treatment phase absent of red blood cell transfusion within the prior 28 days and without excursion of Hgb values above 12 g/dL for ≥2 consecutive weeks. [ Time Frame: Within the prior 28 days of every cycle for a minimum of 2 consecutive weeks. ]
- Proportion of subjects who received at least 1 RBC transfusion. [ Time Frame: From Day 29 to End of Treatment for every cycle. ]
- Change from Baseline in Hemoglobin. [ Time Frame: At Each Visit for every cycle. ]
- Duration of maintaining Hgb values within the range of 10.5 g/dL and 12.0 g/dL. [ Time Frame: At Each Visit for every cycle. ]
- Pharmacokinetics of Peginesatide (PK Cohort Only). [ Time Frame: At Each Visit for every cycle. ]
- Adverse events and serious adverse events. [ Time Frame: At All Visits for every cycle. ]
- Physical examination (including weight, vital signs, and oral temperature). [ Time Frame: At All Visits for every cycle. ]
- Clinical Laboratory Tests and Electrocardiograms. [ Time Frame: At All Visits for every cycle. ]
- Electrocardiograms. [ Time Frame: At Final Visit for every cycle. ]
- Signs and symptoms for thromboembolytic events. [ Time Frame: At All Visits for every cycle. ]
- Proportion of subjects who have incidence of Hgb values >12 g/dL. [ Time Frame: At All Visits for every cycle. ]
- Proportion of subjects who have Hgb increases by more than 1 g/dL in a 2-week period. [ Time Frame: At All Visits for every cycle. ]
- Tumor progression. [ Time Frame: Every 2 cycles of chemotherapy. ]
|Study Start Date:||January 2008|
|Study Completion Date:||June 2008|
|Primary Completion Date:||June 2008 (Final data collection date for primary outcome measure)|
Peginesatide 0.075, 0.1, 0.125, 0.15, 0.175, 0.2, 0.225 or 0.25 mg/kg administered subcutaneously every 3 weeks for a total of at least 2 doses. Subsequent injections given every 3 weeks thereafter regardless of the schedule of subsequent chemotherapy cycles.
Following Study Day 43, subjects may continue on Peginesatide treatment, dosing every 3 weeks until 4 weeks after discontinuation of taxane-containing chemotherapy regimen, the occurrence of a dose limiting toxicity, documented disease progression or change in chemotherapy regimen.
Other Name: Hematide
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00629876
|United States, Florida|
|Jacksonville, Florida, United States|
|United States, Texas|
|Corpus Christi, Texas, United States|
|Study Director:||Vice President Clinical Science||Takeda|