HKI-272 in combination with Vinorelbine in Metastatic Breast Cancer
Research type
Research Study
Full title
A Phase 1/2 Study of HKI-272 in Combination With Vinorelbine in Subjects With Solid Tumors and Metastatic Breast Cancer
IRAS ID
9107
Sponsor organisation
PUMA Biotechnology Inc
Eudract number
2007-007885-39
ISRCTN Number
N/A
Clinicaltrials.gov Identifier
Research summary
This research study will involve subjects with metastatic breast cancer (MBC). When breast cancer spreads beyond the breast, it is said to be metastatic meaning that it has travelled from the breast to another part of the body. Cancer cells can travel through either the lymphatic system or the blood vessels. As there is no cure for MBC, current therapy is palliative or at best, delays disease progression. The main purpose of this study is to continue to learn about the experimental drug HKI-272 when used in combination with the licensed drug vinorelbine. Safety and pharmacokinetic data will be obtained and other markers of efficacy will be assessed (i.e. the subject??s response / duration of the response to the combined therapies).The study is split into two parts, this application is for part 2 only. Eligible subjects must have HER-2 (eRB-b2) positive MBC and will be treated at the maximum tolerated dose of HKI-272 as identified in part 1 of the study.Subjects will sign an informed consent form before any tests or examinations are done and before any questions are asked. Each subject??s suitability for the study will be assessed during a screening visit. The objectives will be assessed throughout the study by physical examinations, laboratory tests on patient??s blood and urine samples, electrocardiogram and by bone, chest, abdomen and brain scans, and scans of any other site of disease.The treatment period will run to up to 12 cycles of treatment, each lasting 21 days. Subjects who either complete the treatment period or withdraw from the study prior to completion will be followed up 2 to 6 weeks after their last dose.
REC name
London - Fulham Research Ethics Committee
REC reference
08/H0711/134
Date of REC Opinion
9 Feb 2009
REC opinion
Further Information Favourable Opinion