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Tyrosine Kinase Inhibitor

Repotrectinib for Solid Tumors in Young Patients

Phase 1 & 2
Recruiting
Research Sponsored by Turning Point Therapeutics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Cohort 1: Subjects with NTRK fusion gene positive (NTRK+) advanced solid tumors (including primary CNS tumors), that are tropomyosin receptor kinase (TRK) TKI naïve
Adequate hematologic, renal and hepatic function
Timeline
Screening 3 weeks
Treatment Varies
Follow Up approximately three years
Awards & highlights

Study Summary

This trial is testing a new drug for safety and effectiveness in treating pediatric and young adult cancer patients.

Who is the study for?
This trial is for young individuals with advanced or metastatic cancers like brain tumors, solid tumors, and lymphoma that have specific genetic changes (ALK, ROS1, NTRK1-3). They should have had prior treatments but be in stable condition. It's not for those with certain heart risks, active infections, severe neuropathy or gastrointestinal conditions affecting drug absorption.Check my eligibility
What is being tested?
The study tests different doses of an oral drug called repotrectinib to find the safest and most effective amount for children and young adults. Phase 1 focuses on safety and finding the right dose; Phase 2 checks how well it works against their cancer.See study design
What are the potential side effects?
While specific side effects aren't listed here, common ones from drugs like repotrectinib could include fatigue, nausea, diarrhea, liver issues and potential heart problems. The exact side effects will be monitored closely during the trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My advanced solid tumor is NTRK fusion positive and I haven't taken TRK inhibitors.
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My blood, kidney, and liver functions are all within normal ranges.
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I am under 12 for Phase 1 or between 12-25 for Phase 2.
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I have previously received chemotherapy.
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My cancer has a confirmed ALK, ROS1, or NTRK1-3 genetic change.
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My brain tumor or cancer spread to the brain is stable, and I've been on a steady or reducing dose of steroids for over 2 weeks.
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My cancer can be measured by specific medical criteria.
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All side effects from my previous cancer treatments, except for hair loss, are mild or gone.
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My cancer has specific genetic changes but doesn't qualify for other study groups.
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I have previously received immunotherapy.
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I can do most activities but need help with some, regardless of my age.
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I have an advanced solid tumor with NTRK+ that has been treated with TRK TKI.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~approximately three years
This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately three years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Dose limiting toxicities (DLTs) (Phase 1)
Overall Response Rate (ORR) (Phase 2)
Pediatric Recommended Phase 2 Dose (RP2D) (Phase 1)
Secondary outcome measures
Area under the concentration versus time curve of repotrectinib in plasma (AUC)
Central Nervous System Progression-Free Survival (CNS-PFS) (Phase 2)
Clinical Benefit Rate (CBR) (Phase 1 and Phase 2)
+7 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Repotrectinib (TPX-0005)Experimental Treatment1 Intervention
Phase 1 Oral repotrectinib (TPX-0005): Safety and tolerability at different dose levels Phase 2 Oral repotrectinib (TPX-0005): 3 cohorts Cohort 1: TKI-naive NTRK fusion Cohort 2: Prior TKI NTRK fusion Cohort 3: ROS1 gene fusions or other ROS1 aberrations

Find a Location

Who is running the clinical trial?

Turning Point Therapeutics, Inc.Lead Sponsor
9 Previous Clinical Trials
827 Total Patients Enrolled
Turning Point Therapeutics, MDStudy DirectorTurning Point Therapeutics
3 Previous Clinical Trials
61 Total Patients Enrolled
Zachary Zimmerman, M.D.Study DirectorTurning Point Therapeutics

Media Library

Repotrectinib (Tyrosine Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04094610 — Phase 1 & 2
Central Nervous System Tumors Research Study Groups: Repotrectinib (TPX-0005)
Central Nervous System Tumors Clinical Trial 2023: Repotrectinib Highlights & Side Effects. Trial Name: NCT04094610 — Phase 1 & 2
Repotrectinib (Tyrosine Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04094610 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the desired outcomes of this research project?

"The goal of this trial is to assess dose-limiting toxicities (DLTs) in Phase 1. Secondary outcomes include overall survival (OS) in Phase 2, duration of response (DOR) in Phase 1 and 2, and time to response (TTR) in Phase 1 and 2."

Answered by AI

Are there any restrictions on who is eligible to participate in this research project?

"This study is investigating a new treatment for cancer in young people. Eligible participants must be between 0 and 25 years old, have lymphoma, and meet the following criteria: A genetic alteration in ALK, ROS1, or NTRK1-3 as confirmed by testing in an accredited laboratory; no active CNS tumors or metastases; prior cytotoxic chemotherapy and immunotherapy are allowed; resolution of all acute toxic effects of prior anti-cancer therapy; measurable disease by RECIST v1.1 or RANO criteria at time of enrollment; a Lansky or Karnofsky score of at least 50."

Answered by AI

Are we still looking for participants in this research?

"That is correct. The information available on clinicaltrials.gov clearly shows that this trial is open and recruiting patients. This specific study was posted on March 20th, 2020 with the most recent update being August 9th, 2020. They are looking for a total of 75 participants who will be spread out across 15 different locations."

Answered by AI

How many individuals are included in this research?

"The sponsor, Turning Point Therapeutics Inc., needs to recruit 75 individuals that meet the study's inclusion criteria from different hospital sites. For example, Stollery Children's Hospital in Edmonton, Alberta and Children's Hospital Los Angeles in Los Angeles, California are both participating locations."

Answered by AI

If a potential research subject is outside the age range of this investigation, can they still participate?

"This particular trial is only for children aged 0 to 25. Out of the 607 trials concerning patients under 18 and the 3800 trials for those over 65, this is one of the few that focuses on this age group."

Answered by AI

Are there different research facilities participating in this trial across Canada?

"Currently, this trial is taking place in 15 different locations including Edmonton, Los Angeles and Dallas. If you are interested in enrolling, it would be most convenient to choose a clinic closest to your home to limit travel requirements."

Answered by AI
~28 spots leftby Sep 2026