Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:55 AM
Ignite Modification Date:
2025-12-25 @ 2:55 AM
NCT ID:
NCT03726333
Eligibility 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03726333
Study Brief:
Protocol Section:
NCT03726333