← Back to Search

Tyrosine Kinase Inhibitor

Hepatic Impairment Study for Lorlatinib in Cancer Patients

Phase 1
Waitlist Available
Research Sponsored by Pfizer
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline up to approximately 1 year
Awards & highlights
No Placebo-Only Group

Summary

This is a phase 1 study in advanced cancer patients with varied hepatic functions to evaluate the potential effect of hepatic impairment on pharmacokinetics and safety of lorlatinib and provide dose recommendation for patients with hepatic impairment if possible.

Eligible Conditions
  • Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline up to approximately 1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline up to approximately 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Area Under Plasma Lorlatinib Concentration-Time Curve From Time 0 to Dosing Interval of 24 Hours (AUC24) at Steady State On Cycle 2 Day 1
Observed Maximal Plasma Concentration (Cmax) at Steady State on Cycle 2 Day 1
Secondary study objectives
Apparent Clearance (CL/F) at Steady State On Cycle 2 Day 1
Duration of Response (DR)
Lorlatinib Area Under Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) After Single Dose on Cycle 1 Day 1
+18 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

5Treatment groups
Experimental Treatment
Active Control
Group I: Group D severe hepatic impairmentExperimental Treatment1 Intervention
continued daily administration of lorlatinib in patients with severe hepatic impairment
Group II: Group C moderate hepatic impairmentExperimental Treatment1 Intervention
continued daily administration of lorlatinib in patients with moderate hepatic impairment
Group III: Group B mild hepatic impairmentExperimental Treatment1 Intervention
continued daily administration of lorlatinib in patients with mild hepatic impairment
Group IV: Group A1 Normal hepatic functionActive Control1 Intervention
continued daily administration of lorlatinib in patients with normal hepatic function
Group V: Group A2 Normal hepatic functionActive Control1 Intervention
continued daily administration of lorlatinib in patients with normal hepatic function
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
lorlatinib
2023
N/A
~550

Find a Location

Who is running the clinical trial?

PfizerLead Sponsor
4,675 Previous Clinical Trials
28,717,181 Total Patients Enrolled
Pfizer CT.gov Call CenterStudy DirectorPfizer
3,556 Previous Clinical Trials
25,758,037 Total Patients Enrolled
~0 spots leftby Jan 2026
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top