Safey tolerability & efficacy of MK-8353 in subjects with solid tumors
Research type
Research Study
Full title
A Phase 1 Study to Evaluate the Safety, Tolerability and Efficacy of MK-8353 (SCH900353)in Subjects With Advanced Solid Tumours (Protocol 001 (formerly P06203)
IRAS ID
117229
Contact name
Daniel Hochhauser
Sponsor organisation
Merck Sharp & Dohme Corp.,subsidiary of Merck & Co.,Inc
Eudract number
2012-002696-33
Clinicaltrials.gov Identifier
Research summary
ERK growth (Extra cellular Kinase) plays a pivotal role in the control of cancer cell growth. The growth of cancer cells is regulated by a balance of action of oncogenes and tumour suppressor genes (genes that prevent cancer cells from growing). Two important Oncogenes called 'RAS and BRAF' which are expressed in human cancer, regain their function in inducing rapid cancer cell growth by interacting indirectly with ERK. SCH90035 (MK8353) is being developed as a novel oral anticancer agent which inhibits ERK (Extracellular Kinase). MK-8353 (SCH9000353) is anticipated to inhibit cancer cell growth in patients that have cancers which express the Oncogenes BRAF and RAF. This patient population has been selected to participate in part 1b & part 2 of this study. MK8353-001(P06203) is a global randomized study being conducted at approximately 20 global sites including 4 UK sites with a total of 117 patients. The study is divided into two parts (part 1 & Part 2). Part 1a: Dose escalation will evaluate safety & tolerability and select the highest tolerable dose (MTD) of MK-8353(SCH900353) to be administered to adults with advanced solid tumours. The UK will participate in Part 1b and Part 2.Part 1b: Confirmation of tolerability. A maximum of 64 patients will participate in Part 1. Part 2: Preliminary evaluation of efficacy of MK-8353 (SCH900353) (by evaluation of Progression free survival at 6 months) at the recommended phase 2 dose (RPTD).Part 1b and Part 2 will enroll only patients with either metastatic melanoma or Colorectal Cancer which express specific mutations that are likely to respond to treatment by MK-8353(SCH900353). Part 1 b will enroll metastatic melanoma patients with NRAS or BRAF and Colorectal Cancer patients with BRAF or KRAS mutations. Part 2 will enroll Metastatic melanoma patients with (NRAS or BRAF mutation previously treated with a MEK inhibitor and Colorectal patients with BRAF or RAS(NRAS or KRAS) mutations.
REC name
London - Surrey Borders Research Ethics Committee
REC reference
12/LO/1892
Date of REC Opinion
1 Feb 2013
REC opinion
Further Information Favourable Opinion