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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE1

Study Classification

INTERVENTIONAL

Study Start Date

2022-07-28

Study Completion Date

2025-12-31

Brief Summary

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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.

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Detailed Description

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This is a Phase 1, multicenter, multiple-dose, open-label, nonrandomized study to evaluate the effect of moderate or severe hepatic impairment on the PK of repotrectinib following single and multiple dose administration of repotrectinib in patients with advanced cancer. This study will enroll 8 patients each with moderate hepatic impairment, severe hepatic impairment and normal hepatic function.

Conditions

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Locally Advanced Solid Tumor Metastatic Solid Tumor

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

repotrectinib (TPX-0005)

Intervention Type DRUG

Oral repotrectinib (TPX-0005)

Interventions

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repotrectinib (TPX-0005)

Oral repotrectinib (TPX-0005)

Intervention Type DRUG

Other Intervention Names

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Oral TPX-0005 capsules repotrectinib

Eligibility Criteria

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Inclusion Criteria

1. 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:

1. 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.
3. Tissue confirmation.
2. For patients with genetic ROS1 or NTRK 1-3 gene fusion, tissue-based local testing should be documented.
3. Biliary obstruction for whom a biliary drain or stent has been placed are eligible.
4. Eastern Cooperative Oncology Group Performance Status scores 0 to 2.
5. The patient must have no clinically significant change in hepatic disease status within the last 30 days before screening.
6. Patient with ascites must not have a paracentesis within 3 months of screening.
7. Protocol specified baseline hematology and kidney function laboratory values

Exclusion Criteria

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No