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Hepatic Impairment Study for Lorlatinib in Cancer Patients

Last updated on June 6, 2019

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Study Location
University of Colorado Denver CTO (CTRC)
Aurora, Colorado, 80045 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Advanced Cancers
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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

NCT03726333
Pfizer
Not yet recruiting
Hepatic Impairment Study for Lorlatinib in Cancer Patients

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Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

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Advanced Cancers
NCT03726333
All Genders
18+
Years
Multiple Sites

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]

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