Clinical Trial of BMS-754807 with Herceptin in Breast Cancer

• Research type

  Research Study

• Full title

  A Phase I/II Trial of BMS-754807 in Combination with Trastuzumab (Herceptin®) in Subjects with Advanced or Metastatic Her-2-positive Breast Cancer Revised Protocol Number 01 (version 2.0, dated 01-Jun-09), incorporating Administrative Letter 01 and Amendment 03. + Pharmacogenetics Blood Sample Amendment Number 01 - Site Specific (version 1.0 dated 13-Aug-08) + Administrative Letter 02, dated 01-Sep-09

• IRAS ID

  49964

• Sponsor organisation

  Bristol-Myers Squibb International Corporation

• Eudract number

  2009-013766-78

• Clinicaltrials.gov Identifier

  NCT00788333

• Research summary

  Breast cancer is a disease with a significant unmet need. The aim of this study is to evaluate the safety and tolerability and to determine the recommended dose or dose range of daily oral BMS-754807 in a combination with Trastuzumab. This is an open-label, multiple-ascending dose study. BMS-754807 will be taken in doses of 20mg to 100mg. Trastuzumab will be given intravenously weekly starting with an initial dose of 4mg/kg followed by weekly 2mg/kg doses. In addition, an oral anti-hyperglycemic agent may be given if hyperglycemia occurs to enhance the tolerability of BMS-754807. Throughout the study, participants will visit the site weekly for intravenous administration of Herceptin©. For tumour assessment, a CT (computed tomography) or MRI (magnetic resonance imaging) scan will be performed every 8 weeks. Other assessments include a 12-lead ECG, an echocardiogram or MUGA scan, vital signs, ECOG status, urine and blood samples, pregnancy testing and glucose meter monitoring. There are 2 parts to the study; dose escalation and dose expansion. The dose escalation part will determine the maximum tolerated dose (MTD) and a recommended Phase II dose or dose range of BMS-754807 and the dose expansion part will assess the anti-tumour activity of the combination. In the dose escalation part, participants will be enrolled in 3 cohorts with the starting dose based on data from study CA191002 at the time of first patient, first dose. In the dose expansion part, participants will receive BMS-754807 at the MTD or recommended phase II dose or at a lower dose agreed by the Investigator and Sponsor. Treatment will continue until disease progression, unacceptable toxicity or at participant's request. The study is expected to last approximately 24 months, with a total of 45-50 participants. 15 participants in the dose escalation part of the study and 30-35 participants in the dose expansion part of the study. The study is sponsored by Bristol-Myers Squibb Co., PO Box 4000, Princeton, NJ 08543

• REC name

  East of England - Essex Research Ethics Committee

• REC reference

  10/H0301/32

• Date of REC Opinion

  20 Jul 2010

• REC opinion

  Further Information Favourable Opinion