Rollover Study: GSK2118436 Continued Treatment for BRAF+ Tumours

• Research type

  Research Study

• Full title

  BRF114144:A Rollover Study to Provide Continued Treatment with GSK2118436 to Subjects with BRAF Mutation-Positive Tumors.

• IRAS ID

  95276

• Contact name

  Hendrik-Tobias Arkenau

• Sponsor organisation

  ICON Clinical Research

• Eudract number

  2011-000883-83

• ISRCTN Number

  not issued

• Research summary

  BRAF is an oncogene that act as part of complex signaling cacades that control events such as cell growth. Aquired mutations in BRAF can cause cancer. By blocking the function of mutated BRAF in cancer patients we may be able to prevent events such as unregulated cell growth. GSK2118436 is an orally administered, potent and selective inhibitor of BRAF function whose safety and efficacy is being investigated by a number a clinical studies at present. One of those studies is a drug-drug interaction study evaluating a number of outcomes including: GSK2118436 ?? warfarin/ketoconazole/gemfibrozil interactions, repeat dosing of GSK2118436, and use of HPMC capsules (as an alternative to gelatin capsules). Consequently, this Phase I rollover study has been designed to provide BRAF mutation patients with continued access to GSK2118436 following their participation in the investigational study of GSK2118436 (parent study). These patients will have shown an acceptable safety profile with GSK2118436 in order to be considered, and patients will be enrolled into the appropriate cohort based upon the treatment received in the parent study. The safety assessments undertaken by participants will include: - physical examinations, - vital signs, - 12-lead electrocardiograms, - echocardiograms, - clinical laboratory assessments, - and monitoring of adverse events throughout the study. Clinical activity will be also assessed using local standard of care imaging practices and the appropriate assessment criteria as determined by the investigator. Participants can be enrolled in this study for treatment with GSK2118436 until they are no longer receiving clinical benefit, develop an unacceptable toxicity, withdraw consent, or have access to local commercial supply of GSK2118436.

• REC name

  London - West London & GTAC Research Ethics Committee

• REC reference

  12/LO/0191

• Date of REC Opinion

  30 Mar 2012

• REC opinion

  Further Information Favourable Opinion