Alectinib Pharmacokinetic in Patients With NSCLC

PHASE1/PHASE2RecruitingINTERVENTIONAL
Enrollment

45

Participants

Timeline

Start Date

May 1, 2022

Primary Completion Date

December 1, 2025

Study Completion Date

December 1, 2025

Conditions
Non-small Cell Lung Cancer Stage IIIBALK Gene Mutation
Interventions
DRUG

Alectinib Oral Product

Alectinib is administered with a sequential dose escalation every 21 days from 300 to 600mg twice daily in the phase 1 portion. In phase 2, patients received an investigator-chosen dose based on the PK analysis.

Trial Locations (1)

14080

RECRUITING

Thoracic Oncology Unit and Personalized Medicine Laboratory, Instituto Nacional de Cancerología, Mexico City

All Listed Sponsors
lead

Instituto Nacional de Cancerologia de Mexico

OTHER