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

Not Recruiting

Trial ID: NCT00445458


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

Stanford Investigator(s)

George A. Fisher Jr.
George A. Fisher Jr.

Colleen Haas Chair in the School of Medicine


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


drug: HKI-272

drug: HKI-272

drug: Paclitaxel

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Mary Chen

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