A Drug-Drug Interaction Study to Assess the Effect of Trametinib on the Pharmacokinetics of an Oral Contraceptive in Female Patients With Solid Tumors

Inclusion Criteria:

- Has a histologically or cytologically confirmed diagnosis of a solid tumor malignancy
(except for any excluded malignancies listed in the Exclusion Criteria) that is not
responsive to standard therapy(ies) or for which there is no approved therapy.

- Meets one of the following criteria: Is currently on a stable regimen of an oral
contraceptive containing 1mg NE and 0.035mg EE, or Is willing to switch to a regimen
of an oral contraceptive containing 1mg NE and 0.035mg EE from a stable regimen of an
alternate OC, or Is willing to start a regimen of an oral contraceptive containing 1mg
NE and 0.035mg EE.

- Meets one of the following criteria: Is post-menopausal, or, Women of child-bearing
potential, defined as all women physiologically capable of becoming pregnant, unless
they are using highly effective methods of contraception during dosing and for four
months after stopping medication.

- Has no prior treatment-related toxicities >Grade 1 (except alopecia) at the time of
enrolment.

- Patient must meet the following laboratory values at the screening visit: Absolute
Neutrophil Count ≥1.5 x 109/L. Platelets ≥75 x 109/L. Hemoglobin (Hgb) ≥9 g/dL. Serum
creatinine <1.5 mg/dL. Total bilirubin ≤1.5 x upper limit of normal (ULN) (isolated
bilirubin >1.5x ULN is acceptable if bilirubin is fractionated and direct bilirubin
<35%). Aspartate transaminase (AST) ≤ 3.0 x ULN, except for patients with liver
metastasis, who may only be included if AST ≤5.0 x ULN. Alanine transaminase (ALT) ≤
3.0 x ULN, except for patients with liver metastasis or tumor infiltration, who may
only be included if ALT ≤5.0 x ULN. Prothrombin time (PT)/International normalized
ratio (INR) and Partial thromboplastin time (PTT) ≤1.5xULN. Note: patients receiving
therapeutic anticoagulation agents prior screening are permitted. Albumin 2.5 g/dL.

- Patient has an Eastern Cooperative Oncology Group (ECOG) performance status 0-1.

Exclusion Criteria:

- 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

- Has had any major surgery, extensive radiotherapy, or anti-cancer therapy (e.g.,
chemotherapy with delayed toxicity, biologic therapy, or immunotherapy) within 21 days
prior to enrolment and/or daily or weekly chemotherapy without the potential for
delayed toxicity within 14 days prior to enrolment. Prolonged immobilization must have
resolved prior to enrolment.

- Has a known or suspected carcinoma that is excluded as administration of Oral
Contraceptive would be contraindicated.

- Has a history of another malignancy.

- Has a history of interstitial lung disease or pneumonitis.

- Has a history of RVO.

- Has a history of any of conditions that would contraindicate administration of an OC

- Has symptomatic or untreated leptomeningeal, brain metastases, or spinal cord
compression.

Other protocol-defined Inclusion/Exclusion criteria may apply.