Hepatic Impairment Study for Lorlatinib in Cancer Patients
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.
Ask AI to explain this studyKey things to know
This describes the study’s primary purpose.
Plus 3 other study approaches.
These are broad labels—not an eligibility decision.
Checked against the public recordLast updated Jun 21, 2024 · Source: ClinicalTrials.gov
Ask the study team to confirm whether enrollment is open.
Interventional
Locations may change over time.
Study sponsor
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 1
- Sponsor
- Pfizer
- Interventions being studied
- Drug: lorlatinib; Drug: lorlatinib; Drug: lorlatinib; Drug: lorlatinib; Drug: lorlatinib
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.
- 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
- 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
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- University of Colorado Denver CTO (CTRC)Aurora, Colorado
- University of Colorado Hospital, Anschutz Cancer Pavilion (ACP)Aurora, Colorado
- University of Colorado Hospital, Anschutz Inpatient Pavilion (AIP)Aurora, Colorado
- University of Colorado Hospital, Anschutz Outpatient Pavilion (AOP)Aurora, Colorado
- Emory University HospitalAtlanta, Georgia
- Investigational Drug ServiceAtlanta, Georgia
- The Emory ClinicAtlanta, Georgia
- Winship Cancer Institute, Emory UniversityAtlanta, Georgia
- Mays Cancer CenterSan Antonio, Texas
- University Health SystemSan Antonio, Texas
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jun 21, 2024. Always confirm current availability with the study team.