TerminatedPhase 1NCT03726333

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.

Checked against the public recordLast updated Jun 21, 2024 · Source: ClinicalTrials.gov

StatusTerminated
PhasePhase 1
U.S. locations10
SponsorPfizer
01
Study overview

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
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

Treatment approach
03
Public criteria

Who may be able to participate

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

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

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.

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