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A Phase 1/2 Study Of HKI-272 In Combination With Vinorelbine In Subjects With Solid Tumors And Metastatic Breast Cancer

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

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Trial Information

A Phase 1/2 Study Of HKI-272 In Combination With Vinorelbine In Subjects With Solid Tumors And Metastatic Breast Cancer

Inclusion Criteria:

- Confirmed pathologic diagnosis of a solid tumor that is not curable with available
therapies for which HKI-272 plus vinorelbine is a reasonable treatment option (part 1
only) or Confirmed pathologic diagnosis of ErbB-2-positive breast cancer (current
stage IV) in female subjects for which vinorelbine plus HKI-272 is a reasonable
treatment option (part 2 only).

- At least 1 prior antineoplastic chemotherapy treatment regimen for metastatic disease
and at least 1 prior treatment with a trastuzumab-containing regimen for at least 6
weeks, for metastatic disease or subject relapsing under adjuvant treatment (part 2

- At least 1 measurable lesion as defined by Response Evaluation Criteria in Solid
Tumors (RECIST).

Exclusion Criteria:

- More than 2 prior antineoplastic treatment regimens (excluding hormonotherapy) for
metastatic disease. Subjects who relapsed under adjuvant treatment shouldn't have
received more than one line of chemotherapy for metastatic disease (part 2 only).

- Prior treatment with vinorelbine for metastatic setting, or prior treatment with any
ErbB-2 targeted agents except trastuzumab (part 2 only). Up to 20 subjects with
ErbB-2-overexpressing metastatic breast cancer who have been previously exposed to
lapatinib but are not refractory to lapatinib may be enrolled in part 2.

- Prior treatment with anthracyclines with a cumulative dose of doxorubicin of greater
than 400 mg/m2, or of epirubicin dose of greater than 800 mg/m2, or the equivalent
dose for other anthracyclines or derivatives (part 2 only).

Type of Study:


Study Design:

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

Outcome Measure:

Safety of the combination of neratinib with vinorelbine.

Outcome Time Frame:


Safety Issue:


Principal Investigator


Investigator Role:

Study Director

Investigator Affiliation:



United States: Food and Drug Administration

Study ID:




Start Date:

April 2008

Completion Date:

December 2013

Related Keywords:

  • Breast Cancer
  • Advanced Malignant Solid Tumors
  • Metastatic breast cancer
  • Breast Neoplasms
  • Neoplasms



Pfizer Investigational Site Blendora, California  91740
Pfizer Investigational Site Bronx, New York  10461
Pfizer Investigational Site North Little Rock, Arkansas  72117
Pfizer Investigational Site Asheville, North Carolina  28801
Pfizer Investigational Site Kingston, Pennsylvania  18704-5535
Pfizer Investigational Site Lebanon, New Hampshire  03766