A Phase I, Multi-center, Open Label, Drug-drug Interaction Study to Assess the Effect of Ceritinib on the Pharmacokinetics of Warfarin and Midazolam in Patients With ALK-positive Advanced Tumors

PHASE1CompletedINTERVENTIONAL
Enrollment

33

Participants

Timeline

Start Date

October 23, 2015

Primary Completion Date

December 12, 2017

Study Completion Date

December 12, 2017

Conditions
ALK-positive Advanced Tumors
Interventions
DRUG

ceritinib

DRUG

warfarin

DRUG

midazolam

Trial Locations (11)

15006

Novartis Investigative Site, A Coruña

20089

Novartis Investigative Site, Rozzano

20133

Novartis Investigative Site, Milan

28046

Novartis Investigative Site, Madrid

28050

Novartis Investigative Site, Madrid

35100

Novartis Investigative Site, Padua

41124

Novartis Investigative Site, Modena

48201

Karmanos Cancer Institute Oncology Department, Detroit

78229

Cancer Therapy & Research Center UT Health Science Center SC-4, San Antonio

48202-2689

Henry Ford Hospital SC, Detroit

DK-2100

Novartis Investigative Site, Copenhagen

Sponsors
All Listed Sponsors
lead

Novartis Pharmaceuticals

INDUSTRY