Cytokinetics Reports Data for Ispinesib recurrent headache and / or neck squamous cell carcinoma
Cytokinetics, Incorporated (Nasdaq: CYTK) announced the results of an interim analysis after phase 1 of the two-stage Phase II clinical Ispinesib administered as monotherapy in the treatment of patients with recurrent head and / or metastatic cervical squamous cell carcinoma ( RMHNSC). This clinical study was conducted by the National Cancer Institute (NCI) in collaboration with GlaxoSmithKline (GSK).The head and neck squamous-cell was second at the European Society for Medical Oncology in Istanbul, Turkey Monday October, 2006 made by Patricia Tang, MD Princess Margaret Hospital Phase II Consortium, Toronto, Canada. This phase II clinical trial evaluating the safety and efficacy of ispinesib at 18 mg/m2 administered intravenously once every 21 hour days rate in patients
RMHNSC who receive more than one prior chemotherapy.designed to require a minimum of a partial or complete response confirmed the 19 evaluable patients in phase 1, to proceed to Step 2. The primary endpoint was response experiments, as determined using RECIST criteria. A total of 21 patients were enrolled, one patient was not evaluable because ispinesib disease progression before treatment, and another for safety, not effectiveness.
to move to Phase 2 The best overall response to date in this study was disease stabilization, which was observed in 5 of 19 patients evaluable for efficacy in cycle 2. Overall, the median time to disease progression of 5.9 (95% CI: 5.4 to 10.0) weeks. The safety and pharmacokinetics of Ispinesib in this study were evaluated in 20 patients
included in the study.) Treats, leukopenia (65%) and neutropenia (65%) were. Other common side effects were nausea (35%), hyponatremia (30%), fatigue (25%), lymphopenia (25%), anemia (20%), injection reaction (15%), vomiting (15% ) and bone pain (5%). The most common adverse event was neutropenia grade 3 or higher that 55% of patients. Two patients died during the study.
days of Grade 3-4 neutropenia, was
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