NCT02705963View on ClinicalTrials.gov

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

PHASE1CompletedINTERVENTIONAL
Enrollment

19

Participants

Timeline

Start Date

October 20, 2016

Primary Completion Date

August 29, 2019

Study Completion Date

August 29, 2019

Conditions
Solid Tumors
Interventions
DRUG

Trametinib

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

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.

DRUG

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

Combined oral contraceptive to be taken orally once daily.

Trial Locations (7)

2650

Novartis Investigative Site, Edegem

5000

Novartis Investigative Site, Namur

29010

Novartis Investigative Site, Málaga

48201

Karmanos Cancer Institute Karmanos Cancer Institute, Detroit

73104

University of Oklahoma, Oklahoma City

6229 HX

Novartis Investigative Site, Maastricht

W1G 6AD

Novartis Investigative Site, London

Sponsors
All Listed Sponsors
lead

Novartis Pharmaceuticals

INDUSTRY