NCT03420742View on ClinicalTrials.gov

A Phase 1 Drug-Drug Interaction Study Between Brigatinib and the CYP3A Substrate, Midazolam, in Participants With ALK-Positive or ROS1-Positive Solid Tumors

PHASE1CompletedINTERVENTIONAL
Enrollment

24

Participants

Timeline

Start Date

June 26, 2019

Primary Completion Date

March 24, 2020

Study Completion Date

April 29, 2021

Conditions
Carcinoma, Advanced ALK+ or ROS1+Non-Small-Cell Lung, Neoplasm, Advanced ALK+ or ROS1+Solid Tumors
Interventions
DRUG

Midazolam

Midazolam syrup.

DRUG

Brigatinib

Brigatinib tablets.

Trial Locations (14)

8028

Hospital Universitario Dexeus, Barcelona

8035

Hospital Universitari Vall d'Hebron, Barcelona

13005

Hopital de la Timone, Marseille

20132

Ospedale San Raffaele, Milan

20141

Istituto Europeo di Oncologia, Milan

28034

Hospital Universitario Ramon Y Cajal, Madrid

28040

Hospital Universitario Fundacion Jimenez Diaz, Madrid

28050

HM Centro Integral Oncologico Clara Campal, Madrid

33081

Centro di Riferimento Oncologico di Aviano, Aviano

40138

Policlinico Sant'Orsola Malpighi, Bologna

43126

Azienda Ospedaliero Universitaria di Parma, Parma

48121

Ospedale Santa Maria delle Croci, Ravenna

75018

Groupe Hospitalier Bichat-Claude Bernard - Hopital Bichat, Paris

1066 CX

Netherlands Cancer Institute, Amsterdam

Sponsors

Lead Sponsor

Takeda
All Listed Sponsors
lead

Takeda

INDUSTRY

NCT03420742 - A Phase 1 Drug-Drug Interaction Study Between Brigatinib and the CYP3A Substrate, Midazolam, in Participants With ALK-Positive or ROS1-Positive Solid Tumors | Biotech Hunter | Biotech Hunter