Hepatic Impairment Study for Lorlatinib in Cancer Patients

• Status: Recruiting
• Trial end date: 2023-04-26
• Target enrollment: 0
• Participant gender: All

Summary

This is a phase 1 study in advanced cancer patients with varied hepatic fucntions 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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pfizer

Criteria

Inclusion Criteria:

• Histologically or cytologically confirmed solid malignancy or lymphoma that is metastatic or unresectable, and for which standard curative or palliative measures do not exist, or are no longer effective;

• Biliary obstruction with a biliary drain or stent;

• Neurologically stable gliomas and brain metastases;

• ECOG performance status of 0, 1, or 2;

• adequate bone marrow function;

• adequate pancreatic function;

• adequate renal function;

• female patients with negative pregnancy test

Exclusion Criteria:

• untreated esophageal varices; uncontrolled ascites;

• episodes of hepatic encephalopathy within the last 4 weeks;

• spinal cord compression; major surgery within 4 weeks prior to enrollment;

• radiation therapy within 2 weeks prior to enrollment;

• last anti-cancer treatment within 2 weeks prior to screening;

• previous high-dose chemotherapy requiring stem cell rescue;

• prior to irradiation to >25% of the bone marrow;

• gastrointestinal abnormalities;

• known prior or suspected hypersensitivity to lorlatinib or lorlatinib tablet;

• clinically significant bacterial, fungal or viral infections for non-liver cancer patients;

• clinically significant cardiovascular disease;

• uncontrolled hypertension; acute pancreatitis with predisposing characteristics;

• history of grade 3 or 4 interstitial fibrosis or interstitial lung disease;

• active hemoelysis or evidence of biliary sepsis;

• prior major gastrointestinal surgery;

• concurrent use of known strong CYP3A inhibitors, inducers and P-gp substrates with a narrow therapeutic index;

• concurrent use of CYP3A substrates with narrow therapeutic indices;

• prior treatment with lorlatinib; active bleeding disorder