A Phase 1/2 Study of HKI-272 (Neratinib) in Combination With Paclitaxel (Taxol) in Subjects With Solid Tumors and Breast Cancer

Inclusion 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

Inclusion Criteria for Part 2 Only:

* Pathologically confirmed breast cancer
* HER2 positive tumor
* Prior treatment with Herceptin

Exclusion Criteria:

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