Trial Search Results

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

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.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Puma Biotechnology, Inc.

Stanford Investigator(s):

Intervention(s):

  • Drug: HKI-272
  • Drug: Paclitaxel

Phase:

Phase 1/Phase 2

Eligibility


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

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Mary Chen
6507238686
Not Recruiting