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#
Status
Purpose
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.
Official Title
A Phase 1/2 Study of HKI-272 in Combination With Paclitaxel in Subjects With Solid Tumors and Breast Cancer
Eligibility Criteria
- 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
- * 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
Investigator(s)
Contact us to find out if this trial is right for you.
Contact
Mary Chen
6507238686
View on ClinicalTrials.gov