drugset / Trial / NCT03726333
Hepatic Impairment Study for Lorlatinib in Cancer Patients
Non-randomizedParallel-groupOpen-labelTreatment
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.
Timeline
- Start
- 2020-01-14
- Primary completion
- 2021-07-08
- Completion
- 2021-07-08
Outcome
Outcome not reported
Stopped (Enrollment): “The study stopped due to lack of enrollment”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Lorlatinib | Small molecule | 50 mg | Oral |
| Subject | Lorlatinib | Small molecule | 100 mg | Oral |