A Phase 1 Study to Assess the Effect of Hepatic Impairment on the Pharmacokinetics of Repotrectinib in Advanced Cancer Patients

Part of paid clinical trials in Canton, Ohio.

Sponsor
Turning Point Therapeutics, Inc.
Study ID
NCT05828277
Phase
PHASE1
Status
Withdrawn

Conditions

  • Locally Advanced Solid Tumor
  • Metastatic Solid Tumor

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

This is a Phase 1 study to evaluate the effect of moderate or severe hepatic impairment on the PK of repotrectinib in patients with advanced cancer.

Key Dates

Start date
Jul 28, 2022
Status verified
Sep 2023
Primary completion
Aug 31, 2025
Completion
Dec 31, 2025

Study Design

Enrollment
0 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Repotrectinib (TPX-0005)
    Oral repotrectinib (TPX-0005): Cohort 1: Patients with moderate hepatic impairment Cohort 2: Patients with severe hepatic impairment Cohort 3: Patients with normal hepatic function

Primary Outcome Measure

Area under the plasma concentration-time curve (AUC) of repotrectinib [ Time Frame: Within 22 days of first repotrectinib dose ]

Locations (1)

FacilityCityStateZIPSite coordinators
Gabrail Cancer Research CenterCantonOhio44718-

Find similar trials in Canton, OH

By research site
Gabrail Cancer Research Center· Canton, OH

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