CTMT212X2102 Study of Trametinib in female patients with solid tumours
Research type
Research Study
Full title
A Phase I, open-label study to determine the effect of\nrepeat dosing of trametinib on the pharmacokinetics of a\ncombined oral contraceptive (norethindrone plus ethinyl\nestradiol) in female patients with solid tumors
IRAS ID
233176
Contact name
ICON
Contact email
Sponsor organisation
Novartis Pharma Services AG
Eudract number
2015-004621-14
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 7 months, 27 days
Research summary
This is a phase I, open-label study to determine the effect of repeat dosing of Trametinib on the pharmacokinetics (PK) (how the study drug is absorbed, distributed, broken down and expelled by the body) of an oral contraceptive in female patients with solid tumours. This is a drug to drug interaction study and its purpose is to check if Trametinib (a cancer drug) will interfere with the function of the oral contraceptive.\nAbout 24 participants will join this study from about 10 hospitals throughout the Unites States of America and Europe.\nThe study will consist of a Screening Period followed by the PK phase which consists of Period 1 (5 days from Day 1 to Day 5) whereby patients will receive daily dosing of the oral contraceptive and Period 2 (17 days from Day 6 to Day 22) whereby patients will commence the administration of tramentinib while continuing with the oral contraceptive. After completing the PK phase of the study, patients will continue in the post-PK treatment (trametinib) part of the study unless they experience disease progression, intolerance of study drug, withdrawal of consent or lost to follow-up. An\nEnd of Treatment (EoT) visit will be performed within 7 days of the last dose of study treatment. The duration of the Screening and PK phase is expected to be approximately 52 days.\nThe following are some of the study procedures that will be performed during study visits: blood tests, urine tests, eye examination and physical examination.
REC name
South Central - Oxford A Research Ethics Committee
REC reference
17/SC/0438
Date of REC Opinion
15 Mar 2018
REC opinion
Further Information Favourable Opinion