ATLAS
Research type
Research Study
Full title
A Phase 2, Open-label Study of Rucaparib in Patients with Locally Advanced or Metastatic Urothelial Carcinoma
IRAS ID
238388
Contact name
Simon Chowdhury, Dr
Contact email
Sponsor organisation
Clovis Oncology, Inc.
Eudract number
2017-004166-10
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
129840, IND Number:
Duration of Study in the UK
1 years, 8 months, 15 days
Research summary
The experimental drug being investigated in this study is called rucaparib (also known as CO338). Rucaparib is approved (trade name: Rubraca®) in the US as treatment for patients with advanced ovarian cancer who have been treated with two or more chemotherapies and who have a certain type of abnormal BRCA gene (also known as the breast cancer susceptibility genes).
Rucaparib belongs to a class of anti cancer agents known as PARP inhibitors (poly [adenosine diphosphate (ADP) ribose] polymerase inhibitors). PARP is a protein inside cells that helps repair damage to DNA, which is the genetic material that carries the instructions for your body’s growth and development and allows cells to continue on living. Cancer can result when there are changes in a person’s genetic material (called DNA mutations) that can cause cancer cells to grow out of control. Research has shown that PARP inhibitors stop the PARP protein from working and that can sometimes cause cancer cells to stop growing.
As part of this study, we will collect samples of tumour tissue and blood to look for biomarkers (substances such as genetic material (DNA) and proteins found in blood and tumour tissue that might show if a cancer patient will respond or will not respond to a treatment). Some cancer biomarkers are known. A change or mutation in one of the BRCA genes is a biomarker for some types of cancer, including breast and ovarian cancer. Research has shown that some patients with cancer and a BRCA mutation may benefit from treatment with a PARP inhibitor. It is possible that some patients with a mutation in a gene that is thought to be similar to BRCA can also benefit from treatment with a PARP inhibitor.
The goal of this study is to evaluate the efficacy (how well the study drug works) and safety of rucaparib, and the pharmacokinetics (PK) to determine whether rucaparib is a good treatment option in patients with urothelial carcinoma. PK is the way the body absorbs, distributes, and gets rid of a drug and provides information on the amount of study drug in the blood.
The study will enrol approx.200 patients who have received 1 or 2 prior standard of care treatment regimens.REC name
East Midlands - Nottingham 2 Research Ethics Committee
REC reference
18/EM/0147
Date of REC Opinion
19 Sep 2018
REC opinion
Further Information Favourable Opinion