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

Completed · Phase 1

Conditions studied: Solid Tumors

In brief

The purpose of this study is to evaluate the effect of trametinib once daily on the pharmacokinetics (PK) of a daily dosing oral contraceptives (OCs) containing norethindrone (NE) and ethinyl estradiol (EE) in female patients with solid tumors. The PK of trametinib and its metabolite M5 will also be assessed.

Key facts

Study ID: NCT02705963
Run by: Novartis Pharmaceuticals
People needed: 19
Starts: 2016-10-20
Expected to finish: 2019-08-29
Last updated by the study team: 2022-02-09

Who can join

Age: 18 and older, up to 59. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

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, must use 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.

You may not qualify if…

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.

Where it is running

Karmanos Cancer Institute Karmanos Cancer Institute — Detroit, Michigan, United States
University of Oklahoma — Oklahoma City, Oklahoma, United States
Novartis Investigative Site — Edegem, Belgium
Novartis Investigative Site — Namur, Belgium
Novartis Investigative Site — Maastricht, Netherlands
Novartis Investigative Site — Málaga, Spain
Novartis Investigative Site — London, United Kingdom

Full record on ClinicalTrials.gov

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