Study Evaluating Neratinib (HKI-272) In Combination With Vinorelbine In Subjects With Solid Tumors And Metastatic Breast Cancer
The purposes of this study are 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 (Tykerb®), 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 (Tykerb®) exposure are also planned to be enrolled in part 2 for exploratory analyses.
Advanced Malignant Solid Tumors
|Study Design:||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase 1/2 Study Of HKI-272 In Combination With Vinorelbine In Subjects With Solid Tumors And Metastatic Breast Cancer|
- Safety of the combination of neratinib with vinorelbine. [ Time Frame: continuous ]
- Overall Response Rate (ORR) in subjects without prior lapatinib exposure. [ Time Frame: every 6 weeks ]
- Clinical benefit (Complete Response [CR]+Partial Response [PR]+ Stable Disease [SD] > 24 weeks) for subjects without prior lapatinib exposure. [ Time Frame: every 6 weeks ]
- Progression-Free Survival [PFS] rate for subjects without prior lapatinib exposure. [ Time Frame: every 6 weeks ]
- Duration of response for subjects without prior lapatinib exposure. [ Time Frame: every 6 weeks ]
|Study Start Date:||April 2008|
|Estimated Study Completion Date:||December 2017|
|Primary Completion Date:||October 2009 (Final data collection date for primary outcome measure)|
neratinib 240mg daily plus vinorelbine 25 mg/m2 on day 1 and day 8 of a 21 days cycle.
Neratinib 240mg daily
Other Name: HKI-272Drug: vinorelbine
vinorelbine 25 mg/m2 on day 1 and day 8 of a 21 days cycle.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00706030
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