Hepatic Impairment Study for Lorlatinib in Cancer Patients

PHASE1TerminatedINTERVENTIONAL
Enrollment

1

Participants

Timeline

Start Date

January 14, 2020

Primary Completion Date

July 8, 2021

Study Completion Date

July 8, 2021

Conditions
Advanced Cancers
Interventions
DRUG

lorlatinib

continued daily administration of 100 mg lorlatinib

DRUG

lorlatinib

continued daily administration of lorlatinib at the dose level same as Group C for the first 22 days and 100 mg QD afterwards

DRUG

lorlatinib

continued daily administration of 100 mg QD lorlatinib

DRUG

lorlatinib

continued daily administration of lorlatinib at 50 mg QD initially and may be adjusted based on PK and safety results from the initial several patients

DRUG

lorlatinib

continued daily administration of lorlatinib at the dose level determined based on preliminary PK and safety results from first several patients in Group C

Trial Locations (10)

30322

Emory University Hospital, Atlanta

Investigational Drug Service, Atlanta

The Emory Clinic, Atlanta

Winship Cancer Institute, Emory University, Atlanta

78229

Mays Cancer Center, San Antonio

University Health System, San Antonio

80045

University of Colorado Denver CTO (CTRC), Aurora

University of Colorado Hospital, Anschutz Cancer Pavilion (ACP), Aurora

University of Colorado Hospital, Anschutz Inpatient Pavilion (AIP), Aurora

University of Colorado Hospital, Anschutz Outpatient Pavilion (AOP), Aurora

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Pfizer

INDUSTRY

NCT03726333 - Hepatic Impairment Study for Lorlatinib in Cancer Patients | Biotech Hunter | Biotech Hunter