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

Phase 1/Phase 2
18 Years
Open (Enrolling)
Advanced Breast Cancer, Advanced Malignant Solid Tumors, Breast Neoplasms

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Trial Information

A Phase 1/2 Study of HKI-272 in Combination With Paclitaxel 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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Number of participants with adverse events

Outcome Time Frame:

At screening, then weekly (for HKI-272 + paclitaxel) or bimonthly (for HKI-272 alone)

Safety Issue:


Principal Investigator


Investigator Role:

Study Director

Investigator Affiliation:



United States: Food and Drug Administration

Study ID:




Start Date:

September 2007

Completion Date:

December 2013

Related Keywords:

  • Advanced Breast Cancer
  • Advanced Malignant Solid Tumors
  • Breast Neoplasms
  • cancer
  • HKI-272
  • neratinib
  • paclitaxel
  • Taxol
  • breast cancer
  • Breast Neoplasms
  • Neoplasms



Investigational Site Boston, Massachusetts  02118
Investigational Site Duarte, California  91010-3000
Investigational Site Lansing, Michigan  48912
Investigational Site New York, New York  10032
Investigational Site San Antonio, Texas  78229