NCT00706030

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

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

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 92 (actual)
• Sponsor: Puma Biotechnology, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Breast Cancer
• Advanced Malignant Solid Tumors

Interventions

Type	Name	Description
DRUG	neratinib
DRUG	vinorelbine

Timeline

• Start date: 2008-04-29
• Primary completion: 2009-10-01
• Completion: 2018-06-07
• First posted: 2008-06-27
• Last updated: 2018-08-09
• Results posted: 2018-05-08

Locations

35 sites across 11 countries: United States, Belgium, China, France, Hong Kong, Netherlands, Poland, Spain, Sweden, Taiwan, United Kingdom

Regulatory

• FDA-regulated drug study