A Phase 1/2 Study of HKI-272 (Neratinib) in Combination With Paclitaxel (Taxol) in Subjects With Solid Tumors and Breast Cancer
Trial ID or NCT#
The purpose of this study is to learn whether it is safe and effective to administer HKI-272 (neratinib) in combination with paclitaxel in patients with breast cancer.
A Phase 1/2 Study of HKI-272 in Combination With Paclitaxel in Subjects With Solid Tumors and Breast Cancer
- Inclusion criteria for both parts of clinical trial: - Good performance status - Normal ejection fraction - Adequate cardiac, kidney, and liver function - Adequate blood counts - At least one measurable target lesion - Negative pregnancy test for female subjects Inclusion Criteria for Part 1 Only: - Pathologically confirmed solid tumor not curable with available standard therapy Inclusion Criteria for Part 2 Only: - Pathologically confirmed breast cancer - HER2 positive tumor - Prior treatment with Herceptin
- Exclusion criteria for both parts of clinical trial: - Major surgery, radiotherapy, chemotherapy or investigational agents within two weeks of treatment day 1 - Subjects with bone or skin as the only site of disease - Active central nervous system metastases - Significant cardiac disease or dysfunction - Significant gastrointestinal disorder - Inability or unwillingness to swallow HKI-272 capsules - Prior exposure to HKI-272 or other HER2 targeted agents, except trastuzumab (Part 2 only). Prior lapatinib is permitted in arm B of part 2. - Treatment with a taxane within 3 months of treatment day 1 - Grade 2 or greater motor or sensory neuropathy - Pregnant or breast feeding women - Known hypersensitivity to paclitaxel or Cremophor EL - Prior treatment with anthracyclines with cumulative dose of >400 mg/m^2 - Any other cancer within 5 years with the exception of contralateral breast cancer, adequately treated cervical carcinoma in situ, or adequately treated basal or squamous cell carcinoma of the skin Exclusion Criteria for Part 2 Only: - More than 1 (arm A) or 3 (arm B) prior cytotoxic chemotherapy regimen for metastatic disease
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