Clinical Trials

Date: 2012-01-12

Type of information: Initiation of the trial

phase: 2

Announcement:

Company: Cancer Research UK (UK)

Product: rucaparib (CO-338; formerly called AG-014699 or PF-01367338)

Action mechanism:

enzyme inhibitor/PARP inhibitor. Rucaparib is a PARP inhibitor. PARP inhibitors block PARP, a protein which is part of DNA's 'emergency repair kit' in cells - it prevents mistakes being passed on when cells grow and divide. An alternative 'repair kit' is also controlled by the BRCA1 and BRCA2 genes - these genes are faulty in some cancer cells. When both copies of the BRCA1 or BRCA2 genes are faulty, the cells rely on the PARP pathway to repair damaged DNA. By blocking PARP with drugs, cancer cells which have lost BRCA1 or BRCA2 can no longer repair DNA damage and they die. This is why PARP inhibitors are effective in treating the small percentage of cancers in which BRCA1 or BRCA2 is faulty. Because cancer treatments such as radiotherapy and chemotherapy kill cells by damaging DNA, PARP inhibitors also have the potential to increase the effectiveness of some of these treatments, even in cancers that do not have mutations in BRCA1 or BRCA2.

Disease: inherited breast and ovarian cancers

Therapeutic area: Cancer - Oncology

Country: UK

Trial details:

The Phase II clinical trial is led by The Sir Bobby Robson Cancer Trials Research Centre, Newcastle University and The Newcastle upon Tyne Hospitals NHS Foundation Trust, and also runs across The Beatson West of Scotland Cancer Centre, UCL, Plymouth Oncology Centre, University of Birmingham Hospital, Christie Hospital, Manchester; and St James’ University Hospital, Leeds. Women with advanced breast or ovarian cancer with faults in the known high-risk BRCA1 or BRCA2 genes will receive Rucaparib . The trial is also open to women with advanced serous ovarian cancer but unknown BRCA status. Patients take the drug as a daily tablet at home over a period of 21 days, only coming to hospital for check-ups and tests. This treatment plan replaces an earlier version of the trial of the drug where it was delivered intra-venously to patients on five days over the same period. The trial will initially establish the dosing schedule for the drug and evaluate whether it is effective for these patients.

Latest news:

Cancer Research UK’s Drug Development Office has re-launched a trial of a promising drug to treat inherited breast and ovarian cancer – but this time taken as a tablet by outpatients. This latest trial is being funded and managed by the charity’s Drug Development Office (DDO). This drug was developed through work led by Cancer Research UK scientists.