Breast Cancer Clinical Trial
Official title:
A Phase 1/2, Open-Label Study Of Neratinib (HKI-272) In Combination With Capecitabine In Subjects With Solid Tumors And ErbB-2 Positive Metastatic Or Locally Advanced Breast Cancer
This is a world wide phase 1/2, open-label, study of neratinib in combination with
capecitabine, conducted in 2 parts.
In Part 1, 3 to 9 subjects with solid tumors will be enrolled in each dose group of the
combination of neratinib and capecitabine. Each subject will participate in only 1 dose
group.
Additional subjects may be included at any dose level to further assess the safety and
tolerability at that dose level.
In Part 2, up to 60 subjects with erbB-2 positive metastatic breast cancer will receive
treatment with the combination of neratinib and capecitabine at the maximum tolerated dose
level, as determined in Part 1. In addition 20 subjects with prior lapatinib exposure will be
enrolled in Part 2.
Depending on the safety and activity profile observed during the dose escalation phase, the
dose selected for Part 2 may be adjusted, if appropriate. In case one test article of the
combination is discontinued due to intolerance the other test article can be administered
alone.
The primary objectives of Part 1 are to assess the safety and tolerability, and to define the
maximum tolerated dose (MTD) of neratinib in combination with capecitabine in subjects with
advanced solid tumors.
The primary objective of Part 2 of this study is to confirm the MTD determined in Part 1.
The secondary objective of Part 1 is to collect information on preliminary anti-tumor
activity of the combination of neratinib and capecitabine.
Secondary objectives for Part 2 are to collect pharmacokinetic information and to obtain
additional efficacy data, such as Objective Response Rate, for subjects with erbB-2 positive
breast cancer treated at the MTD of neratinib + capecitabine.
n/a
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