Study on Repotrectinib for Patients with Advanced Solid Tumors with ALK, ROS1, or NTRK Gene Changes

Sponsor: Turning Point Therapeutics, Inc.

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT03093116

Provider View

This clinical trial is testing a new drug, Repotrectinib, to see if it is safe and effective for treating advanced solid tumors with specific gene changes. The study will explore how well the drug works and its side effects.

Patient Parameters

Program Overview

The study aims to find the best dose of Repotrectinib for patients with advanced solid tumors that have specific gene changes (ALK, ROS1, or NTRK). It will also look at how the drug affects the body and how well it works in shrinking tumors. The trial is divided into two phases: Phase 1 will focus on finding the right dose, and Phase 2 will evaluate the drug's effectiveness in different groups of patients.

Description

In Phase 2, patients will be divided into six groups based on their previous treatments and the type of gene change in their cancer:

  • Group 1: Patients with ROS1-positive non-small cell lung cancer (NSCLC) who have not received ROS1-targeted therapy but may have had one prior chemotherapy or immunotherapy.
  • Group 2: Patients with ROS1-positive NSCLC who have had one ROS1-targeted therapy and one platinum-based chemotherapy.
  • Group 3: Patients with ROS1-positive NSCLC who have had two ROS1-targeted therapies but no chemotherapy.
  • Group 4: Patients with ROS1-positive NSCLC who have had one ROS1-targeted therapy but no chemotherapy or immunotherapy.
  • Group 5: Patients with NTRK-positive solid tumors who have not received TRK-targeted therapy.
  • Group 6: Patients with NTRK-positive solid tumors who have had one or two TRK-targeted therapies.

The study will assess how well Repotrectinib works in shrinking tumors, how long the response lasts, and the overall survival of patients. It will also monitor any side effects and how the drug interacts with other medications.

Eligibility Criteria

Inclusion Criteria

  • Have a confirmed diagnosis of advanced solid tumor with specific gene changes (ALK, ROS1, or NTRK).
  • Be 18 years or older (or 20 years or older if required by local regulations).
  • Be able to swallow capsules whole.
  • Have at least one measurable tumor.
  • Have previously received chemotherapy or immunotherapy.
  • Have stable lab test results and be in good overall health.
  • Have a life expectancy of at least 3 months.
  • For Phase 2, patients must have a confirmed ROS1 or NTRK gene change and meet specific testing requirements.
  • Be willing to provide informed consent and follow study procedures.

Exclusion Criteria

  • Currently participating in another clinical trial.
  • Have symptomatic brain metastases or leptomeningeal disease.
  • Have had another cancer requiring treatment in the past 2 years, except for certain skin cancers.
  • Have had major surgery or radiation therapy recently.
  • Have significant heart disease or abnormal heart rhythms.
  • Have active infections or gastrointestinal diseases affecting drug absorption.
  • Have severe nerve damage or lung disease.

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