Who is sponsoring NCT00706030?

NCT00706030 is sponsored by Puma Biotechnology, Inc..

What condition does NCT00706030 study?

NCT00706030 studies Breast Cancer, Advanced Malignant Solid Tumors.

What drugs are being tested in NCT00706030?

Interventions: neratinib, vinorelbine.

What is the status of NCT00706030?

NCT00706030 is currently COMPLETED.

Last reviewed 2018-07-11 · How we verify

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

NCT00706030 Phase 1/Phase 2 COMPLETED Results posted

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.

Details

Lead sponsor	Puma Biotechnology, Inc.
Phase	Phase 1/Phase 2
Status	COMPLETED
Enrolment	92
Start date	2008-04-29
Completion	2018-06-07

Conditions

Breast Cancer
Advanced Malignant Solid Tumors

Interventions

neratinib
vinorelbine

Primary outcomes

Overall Response Rate — From first dose date to progression or last tumor assessment, up to four years and six months.
Overall Response Rate (ORR), subjects with CR or PR by independent review in subjects with ErbB-2-positive breast cancer treated at the MTD of neratinib in combination with vinorelbine per Response Evaluation Criteria In Solid Tumors Criteria (RECIST) v1.0: Complete Response (CR), disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; and Non-PD for non-target lesions, and no new lesions.
Maximum Tolerated Dose — From Day 1 to Day 21.
Maximum Tolerated Dose (MTD) of Neratinib in combination with vinorelbine in subjects with advanced solid tumors.

Countries

United States, Belgium, China, France, Hong Kong, Netherlands, Poland, Spain, Sweden, Taiwan, United Kingdom