Hepatic Impairment Study for Lorlatinib in Cancer Patients

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