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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 SiteBlendora, California  91740
Pfizer Investigational SiteBronx, New York  10461
Pfizer Investigational SiteNorth Little Rock, Arkansas  72117
Pfizer Investigational SiteAsheville, North Carolina  28801
Pfizer Investigational SiteKingston, Pennsylvania  18704-5535
Pfizer Investigational SiteLebanon, New Hampshire  03766