A Phase 1b/2 Trial to Assess SRA737 in Combination with Niraparib
Research type
Research Study
Full title
A Phase 1b/2, Open-label, Multicenter Dose-ranging Trial to Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of SRA737 in Combination With Niraparib in Subjects With Metastatic Castration-resistant Prostate Cancer
IRAS ID
240374
Contact name
Johann De-Bono
Contact email
Sponsor organisation
Sierra Oncology
Eudract number
2017-004927-56
Clinicaltrials.gov Identifier
N/A, N/A
Duration of Study in the UK
2 years, 0 months, 0 days
Research summary
This study is looking at whether SRA737 taken together with niraparib, will be safe and tolerable in patients with Metastatic Castration Resistant Prostate cancer, (mCRPC). Both SRA737 and niraparib are in the form of a capsule to be taken by mouth with water.
SRA737 is a type of drug called a kinase inhibitor. Kinase inhibitors are a new type of drug being used to try to stop the growth of cancers and to kill cancer cells. SRA737 blocks a protein messenger (enzyme) called checkpoint kinase 1 (Chk1) which is important in a cellular process to ensure that damaged DNA can be repaired properly. Some cancer cells rely on Chk1 to keep growing. SRA737 is thought to block Chk1 so the cancer cells that rely on Chk1 will die. SRA737 looks promising in research laboratory and animal studies. We now wish to find out if SRA737 will be safe and useful in treating patients with cancer.
Niraparib is a poly ADP ribose polymerase (PARP) inhibitor. PARP inhibitors are a new type of drug being used to try to stop the growth of cancers and to kill cancer cells. Like SRA737, niraparib blocks a protein messenger (enzyme) called poly ADP ribose polymeras, (PARP). The role of PARP is to notice and start a response to DNA damage. Some cancer cells rely on PARP to grow. By blocking PARP, repairing of DNA damage is prevented and the cancer cell dies. Niraparib is an approved medication in the US and EU for ovarian, fallopian tube, or primary peritoneal cancer.REC name
London - Surrey Borders Research Ethics Committee
REC reference
18/LO/0982
Date of REC Opinion
12 Jul 2018
REC opinion
Further Information Favourable Opinion