NCT05828277

Brief Summary

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.

Trial Health

33
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jul 2022

Typical duration for phase_1

Geographic Reach
2 countries

2 active sites

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 28, 2022

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

March 28, 2023

Completed
28 days until next milestone

First Posted

Study publicly available on registry

April 25, 2023

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2025

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

September 26, 2023

Status Verified

September 1, 2023

Enrollment Period

3.1 years

First QC Date

March 28, 2023

Last Update Submit

September 22, 2023

Conditions

Locally Advanced Solid TumorMetastatic Solid Tumor

Outcome Measures

Primary Outcomes (2)

  • Area under the plasma concentration-time curve (AUC) of repotrectinib

    AUC0-t: Area under the plasma concentration-time curve from time 0 to the time of the last measurable concentration

    Within 22 days of first repotrectinib dose

  • Maximum Observed Plasma Concentration (Cmax) of repotrectinib

    Cmax: Evaluate the maximum plasma concentration

    Within 22 days of first Repotrectinib dose

Secondary Outcomes (1)

  • Evaluate safety and tolerability

    28 days after last dose of repotrectinib

Study Arms (1)

Repotrectinib (TPX-0005)

EXPERIMENTAL

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

Drug: repotrectinib (TPX-0005)

Interventions

repotrectinib (TPX-0005)DRUG

Oral repotrectinib (TPX-0005)

Also known as: Oral TPX-0005 capsules, repotrectinib
Repotrectinib (TPX-0005)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histologically or cytologically confirmed diagnosis of locally advanced or metastatic solid tumor for which standard curative or palliative measures do not exist or are no longer effective. In case of hepatocellular carcinoma, the diagnosis should be based on at least 1 of the following:
  • The presence of at least 1 lesion, measuring ≥2 cm, with characteristic arterial enhancement and venous washout in the setting of liver cirrhosis and/or hepatitis B or C infection.
  • Tissue confirmation.
  • For patients with genetic ROS1 or NTRK 1-3 gene fusion, tissue-based local testing should be documented.
  • Biliary obstruction for whom a biliary drain or stent has been placed are eligible.
  • Eastern Cooperative Oncology Group Performance Status scores 0 to 2.
  • The patient must have no clinically significant change in hepatic disease status within the last 30 days before screening.
  • Patient with ascites must not have a paracentesis within 3 months of screening.
  • Protocol specified baseline hematology and kidney function laboratory values

You may not qualify if:

  • Concurrent participation in another therapeutic clinical study.
  • Symptomatic brain metastases or leptomeningeal involvement.
  • Major surgery within 4 weeks.
  • Clinically significant cardiovascular disease.
  • History of non-pharmacologically induced prolonged QT interval corrected for heart rate interval.
  • Known active infections requiring ongoing treatment (bacterial, fungal, or viral, including human immunodeficiency virus positivity).
  • Gastrointestinal disease or other malabsorption syndromes.
  • Current use or anticipated need for drugs that are known to be strong cytochrome P450 (CYP) 3A inhibitors or inducers.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Gabrail Cancer Research Center

Canton, Ohio, 44718, United States

Location

Local Institution - 4103

Madrid, 28033, Spain

Location

MeSH Terms

Conditions

Neoplasm Metastasis

Interventions

repotrectinib

Condition Hierarchy (Ancestors)

Neoplastic ProcessesNeoplasmsPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Bristol-Myers Squibb

    Bristol-Myers Squibb

    STUDY DIRECTOR
0

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR
Expanded Access
Yes

Study Record Dates

First Submitted

March 28, 2023

First Posted

April 25, 2023

Study Start

July 28, 2022

Primary Completion

August 31, 2025

Study Completion

December 31, 2025

Last Updated

September 26, 2023

Record last verified: 2023-09

Locations

US(1)ES(1)