Status:
COMPLETED
A Phase 1/2 Study of HKI-272 (Neratinib) in Combination With Paclitaxel (Taxol) in Subjects With Solid Tumors and Breast Cancer
Lead Sponsor:
Puma Biotechnology, Inc.
Conditions:
Advanced Breast Cancer
Advanced Malignant Solid Tumors
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 11 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 7 2018
Estimated Enrollment :
110 Patients enrolled
Trial Details
Trial ID
NCT00445458
Start Date
September 11 2007
End Date
February 7 2018
Last Update
July 26 2018
Active Locations (32)
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1
Scripps, Clinic General
La Jolla, California, United States, 92037
2
Moores UC San Diego Cancer Center
La Jolla, California, United States, 92093
3
Sharp Memorial Hospital
San Diego, California, United States, 92123
4
Boston University Medical Center
Boston, Massachusetts, United States, 02118