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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

    NCT00706030

  • 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