A Phase 1/2 trial of oral SRA737 given in combination
Research type
Research Study
Full title
A Phase 1/2 Trial of Oral SRA737 (a Chk1 Inhibitor) Given in Combination with Gemcitabine plus Cisplatin or Gemcitabine Alone in Subjects with Advanced Cancer
IRAS ID
198606
Contact name
Udai Banerji
Contact email
Sponsor organisation
Sierra Oncology, Inc.
Eudract number
2015-004467-36
Duration of Study in the UK
2 years, 7 months, 0 days
Research summary
This clinical study is looking at a new drug called SRA737 which looks promising in laboratory studies when given with other cancer medicines (known as chemotherapy). We now wish to find out if it will be useful in treating patients with cancer when given with chemotherapy. The chemotherapy used in this study will be gemcitabine. This chemotherapy is currently used as a standard treatment for cancer, however in this study it is given in a lower dose.
SRA737 is a type of drug called a kinase inhibitor. It blocks a chemical messenger (enzyme) called checkpoint kinase 1 (Chk1) which is part of the signaling process within cells which can make cells produce chemicals that trigger and control cell growth and cell death. Chemotherapy agents are used to try to kill cancer cells however sometimes cancer cells can repair themselves using these signaling processes and continue to grow. Chemotherapy may help SRA737 to work better by preventing cancer cells from repairing themselves, so that more cancer cells will be killed.
Stage 1 is now closed to enrollment. In stage 2 patients will be given SRA737 to take in addition to receiving treatment with gemcitabine.
The study will be split into two parts: Part one will be a ‘dose escalation’ phase where groups of patients will receive increasing doses of SRA737 to find the best dose to treat patients with. Part two will be an ‘expansion phase’ where a larger group of patients will be treated at the highest dose level of SRA737 considered to be safe from part one to find out more about how the drug is working.REC name
London - Surrey Borders Research Ethics Committee
REC reference
16/LO/0422
Date of REC Opinion
25 Apr 2016
REC opinion
Further Information Favourable Opinion