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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

19 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-10-20

Study Completion Date

2019-08-29

Brief Summary

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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.

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Detailed Description

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Conditions

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Solid Tumors

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Oral Contraceptive / Trametinib

In treatment period 1 of the PK Phase patients will take the Oral Contraceptive once daily from Days 1-5. Period 2 of the PK Phase starts on Day 6 when patients take both the Oral Contraceptive and trametinib once daily from Days 6 to 21. Patients may continue dosing with trametinib only once daily from Day 22 onwards (post PK Phase).

Group Type EXPERIMENTAL

Trametinib

Intervention Type DRUG

Each tablet is 2mg trametinib to be taken orally once daily.

Trametinib

Intervention Type DRUG

Each tablet is 0.5mg trametinib to be taken orally once daily. 0.5mg tablets may be used if a dose reduction is required.

Oral Contraceptive (1mg norethindrone, 0.035mg ethinyl estradiol)

Intervention Type DRUG

Combined oral contraceptive to be taken orally once daily.

Interventions

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Trametinib

Each tablet is 2mg trametinib to be taken orally once daily.

Intervention Type DRUG

Trametinib

Each tablet is 0.5mg trametinib to be taken orally once daily. 0.5mg tablets may be used if a dose reduction is required.

Intervention Type DRUG

Oral Contraceptive (1mg norethindrone, 0.035mg ethinyl estradiol)

Combined oral contraceptive to be taken orally once daily.

Intervention Type DRUG

Eligibility Criteria

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Exclusion Criteria

* 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.

* 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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

59 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No