Study Evaluating Neratinib (HKI-272) In Combination With Vinorelbine In Subjects With Solid Tumors And Metastatic Breast Cancer



Status:Completed
Conditions:Breast Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:8/11/2018
Start Date:April 29, 2008
End Date:June 7, 2018

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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

The purpose of this study is to identify the highest tolerable dose of neratinib (HKI-272) in
combination with vinorelbine and to assess the safety of the combination of the two drugs as
well as to obtain preliminary information on whether the combination of the two drugs has any
effect on solid tumors.

The study will be conducted in two parts. In the first part, testing will be done on up to 12
subjects to determine the highest tolerable dose of HKI-272 and vinorelbine in patients with
advanced solid tumors. In the second part of the study, approximately 60 additional subjects
with metastatic ErbB-2-positive breast cancer, with no prior exposure to lapatinib, are
planned to be added to better define the tolerability and preliminary activity of HKI-272 in
combination with vinorelbine. Up to 20 additional subjects with ErbB-2-positive breast cancer
with prior lapatinib exposure are also planned to be enrolled in part 2 for exploratory
analyses.


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
only).

- 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).
We found this trial at
9
sites
Philadelphia, Pennsylvania 19111
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Philadelphia, PA
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One Medical Center Drive
Lebanon, New Hampshire 03756
(603) 653-9000
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center Norris Cotton Cancer Center at DHMC in...
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Lebanon, NH
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Brasschaat,
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Brasschaat,
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Bronx, New York 10461
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Bronx, NY
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Charlotte, North Carolina 28203
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Charlotte, NC
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1500 East Duarte Road
Duarte, California 91010
626-256-HOPE (4673)
City of Hope National Medical Center City of Hope is dedicated to making a difference...
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Duarte, CA
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Fayetteville, Arkansas 72703
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Fayetteville, AR
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630 W 168th St
New York, New York
212-305-2862
Columbia University Medical Center Situated on a 20-acre campus in Northern Manhattan and accounting for...
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New York, NY
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Nyack, NY
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