LOGS
Research type
Research Study
Full title
A randomized phase II/III study to assess the efficacy of trametinib (GSK 1120212) in patients with recurrent or progressive low-grade serous ovarian cancer or peritoneal cancer (GOG-0281)
IRAS ID
143994
Contact name
Charles Gourley
Contact email
Sponsor organisation
NHS Greater Glasgow and Clyde
Eudract number
2013-001627-39
Clinicaltrials.gov Identifier
Duration of Study in the UK
9 years, 8 months, 1 days
Research summary
The purpose of this study is to compare the effects of a new drug Trametinib with the standard treatments currently available for treating low grade serous ovarian or peritoneal cancer (either letrozole, tamoxifen, paclitaxel, Pegylated Liposomal Doxorubicin (PLD), or topotecan) to find out whether Trametinib is more effective than the current treatment options.
Trametinib is a drug that blocks a very important signal that controls the growth of cancer cells. It is thought that this signal is important in a variety of cancers, including low-grade serous ovarian and peritoneal cancers. Trametinib is experimental and has not yet been studied in patients with low-grade serous ovarian or peritoneal cancer.
In order to study this, a randomised controlled trial is being conducted. In this study half of the patients will be treated with standard chemotherapy or hormone drugs (the choice of this ‘standard’ agent will be advised by at the discretion of the patient's doctor) with the other half of patients entered to the study receiving the new drug Trametinib. A total of 250 patients will be recruited to the study globally.
In addition to the treatment part of this study, the researchers plan to test samples of patient's tumours and blood. The purpose of this research is to determine whether the presence of certain proteins and genes predict if this drug will be an effective treatment for ovarian or peritoneal cancer. The researchers will also use samples of blood to determine how much of the study drug (trametinib) is present in patients' blood which are receiving trametinib.
REC name
East of Scotland Research Ethics Service REC 2
REC reference
14/ES/1064
Date of REC Opinion
16 Oct 2014
REC opinion
Further Information Favourable Opinion