Solid tumors Solid tumors with a BRAF V600 mutation
Conditions
Interventions
This study investigates the effect of trametinib once daily on the PK of a
daily dosing OC containing NE and EE in female patients with solid tumors.
Sponsors
Novartis
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Patients eligible for inclusion in this study have to meet all of the following criteria:;1. Is a female patient * 18 years but Grade 1 (except alopecia) at the time of enrolment.;8. Is able to
Exclusion criteria
Exclusion criteria: Patients eligible for this study must not meet any of the following criteria:;1. Had prior exposure to a MEK inhibitor.;2. Has one of the following excluded tumor types as trametinib therapy has been shown to have minimal benefit in these populations: - BRAF V600E mutant melanoma and failed prior BRAF inhibitor therapy. - Metastatic pancreatic cancer.;3. History or current diagnosis of cardiac disease indicating significant risk of safety for patients participating in the study such as uncontrolled or significant cardiac disease, including any of the following: - Recent myocardial infarction (within last 6 months). - Uncontrolled congestive heart failure. - Unstable angina (within last 6 months). - Clinically significant (symptomatic) cardiac arrhythmias (e.g., sustained ventricular tachycardia, and clinically significant second or third degree AV block without a pacemaker). Note: Patients with controlled atrial fibrillation for >30 days prior to enrolment are eligible.;- History of coronary angioplasty, or stenting within last 6 months.;- History or evidence of current * Class II congestive heart failure as defined by New York Heart Association (NYHA).;- Has an intra-cardiac defibrillator.;- Has a Fridericia-corrected QT (QTcF) interval *460 msec at Screening.;- Has a LVEF, as measured by ECHO (preferred) or MUGA scan, below the institutional LLN, or if a LLN does not exist at an institution,
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the effect of multiple daily dose of trametinib on the steady state PK of combination OC (NE and EE) in female patients with solid tumors. | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective 1: To characterize the steady state PK of metabolite M5 when trametinib is administered in combination with combination OC in female patients with solid tumors Objective 2: To evaluate the safety and tolerability of trametinib in female patients with solid tumors. | — |
Countries
Netherlands
Outcome results
None listed