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Keep this study
Lead
Puma Biotechnology, Inc.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
\- Pathologically confirmed solid tumor not curable with available standard therapy
Pathologically confirmed breast cancer
HER2 positive tumor
Prior treatment with Herceptin
You may not be if
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
\- More than 1 (arm A) or 3 (arm B) prior cytotoxic chemotherapy regimen for metastatic disease
Clareo Health | A Phase 1/2 Study of HKI-272 (Neratinib) in Combination With Paclitaxel (Taxol) in Subjects With Solid Tumors and Breast Cancer
