A randomised phase II/III study to assess the efficacy of trametinib (GSK 1120212) in patients with recurrent or progressive low-grade serous ovarian cancer of peritoneal cancer (GOG-0281).
Study Description: This trial is an Intergroup Trial jointly conducted by Cancer Therapy Evaluation Program (CTEP)/Gynecologic Oncology Group (GOG) from USA and National Cancer Research Network [NCRN] United Kingdom. In the UK the trial is being run under the auspices of the NCRN/NCRI Gynaecology Clinical Study Group. This study is endorsed by Cancer Research UK (CTAAC), and is part funded by GlaxoSmithKline under the terms of their collaboration with the National Cancer Research Network.
The Cancer Research UK Clinical Trials Unit, Glasgow (CTU) is co-ordinating the UK participation in the trial on behalf of NCRI/NCRN, NHS GG C and GU.
Study Design: Prospective, multicentre, observational study incorporating a nested cross-sectional sub-study
Primary Objective: Prospective, multicentre, observational study incorporating a nested cross-sectional sub-study
- To determine the nature, frequency and maximum degree of toxicity as assessed by CTCAE v4 for each treatment arm
- To determine the quality of life, as assessed by the FACT-O
- To compare trametinib to the control arm with regard to patients' self-reported acute (up to post-cycle 6) quality of life as measured by the FACT-O-TOI.
- To compare trametinib to the control arm with regard to patients' self-reported acute (up to post-cycle 6) neurotoxicity as measured by the FACT-GOG-NTX.
- To estimate the objective response rate (RR) of patients in each treatment arm.
There are also exploratory and translational objectives for the study.
Study Design: This is an unblinded, randomized phase II\III study of comparing trametinib to 'standard therapy' (consisting of one of five commercially available agents) in patients with low-grade serous carcinoma of the ovary or peritoneum previously treated with platinum-based chemotherapy treated with in women with recurrent low-grade serous.
Patients will be randomized in a 1 : 1 ratio to receive Trametinib or standard of care (the control arm). The randomization will be stratified using minimization by the following factors: geographic region (UK or US), performance status (0 or 1), number of prior treatment regimens, and planned treatment regimen (if in the control arm).
Trial Status: Recruiting
Chief Investigator: Professor Charlie Gourley (UK Chief Investigator)
Sponsor: NHS Greater Glasgow Clyde and University of Glasgow (UK Sponsors)
Date Opened: 24 August 2015 for UK
Planned Closure Date: Expected June 2018
Target Recruitment: Globally 250 patients
Open to New Sites: Yes
Contact Details: Clinical Trial Unit (CTU), Glasgow
Karen Carty , (Project Manager)
Cancer Research UK Clinical Trials Unit, Glasgow
Level 0, The Beatson West of Scotland Cancer Centre
1053 Great Western Road, Glasgow, G12 0YN
Tel: 00 44 (0) 141 301 7197
Fax: 00 44 (0) 141 301 7946
E-mail: [email protected]
Investigator Initiation Slides
Pharmacy Initiation Slides
For queries concerning Pharmacovigilance, or the documents to refer to for the clinical management of trial patients or those that are acting as the Reference Safety Information please contact:
The Pharmacovigilance Team email: [email protected] or Telephone: 0141 211 0352/0203/3567/3968 or 0141 232 2068
Version of NCI Common Terminology Criteria for Adverse Events (CTCAE) being used for the study (if applicable): 4.03
Click here to download the CTCAE