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Tyrosine Kinase Inhibitor

Entrectinib for Solid Tumors (STARTRK-NG Trial)

Phase 1 & 2
Waitlist Available
Research Sponsored by Hoffmann-La Roche
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Participants must have histologic/molecular diagnosis of malignancy at diagnosis or the time of relapse
Participants must have Lansky or Karnofsky score ≥ 60% and minimum life expectancy of at least 4 weeks
Must not have
Familial or personal history of congenital bone disorders, bone metabolism alterations or osteopenia
Receiving Enzyme Inducing Antiepileptic Drugs (EIAEDs) within 14 days of first dose
Timeline
Screening 3 weeks
Treatment Varies
Follow Up approximately 24 months
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a new cancer treatment in children with solid tumors that have come back or are not responding to other treatments. The treatment targets tumors with specific gene mutations.

Who is the study for?
This trial is for children and adolescents with advanced or metastatic solid tumors or primary CNS tumors that have specific gene fusions (NTRK1/2/3 or ROS1) and no satisfactory treatment options. They must have a certain level of physical function, recovered from previous treatments, adequate organ function, not be pregnant or breastfeeding, and agree to use contraception.
What is being tested?
Entrectinib is being tested in this study which includes two phases: Phase 1 focuses on dose escalation in patients with relapsed/refractory extracranial solid tumors; Phase 2 expands to include those with brain tumors harboring specific gene fusions. The goal is to determine the appropriate dosage and assess its effectiveness.
What are the potential side effects?
While not specified here, potential side effects of Entrectinib may include fatigue, dizziness, altered taste sensation, constipation/diarrhea, weight changes, muscle/joint pain. Serious side effects could involve heart rhythm problems or liver issues.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My cancer was confirmed by lab tests when diagnosed or at relapse.
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I can do most activities and am expected to live at least 4 more weeks.
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My cancer is advanced, can't be removed by surgery without severe side effects, and has no good treatment options.
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I have recovered from the side effects of my previous cancer treatments.
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My organs and nervous system are functioning well.
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My brain tumor has NTRK1/2/3 or ROS1 gene changes.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have a family or personal history of bone disorders or weak bones.
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I have not taken any seizure medications that affect enzymes in the last 14 days.
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I have been treated with TRK or ROS1 inhibitors before.
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My neuroblastoma is only in my bone marrow.
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I do not have any stomach or intestine problems that affect how drugs are absorbed.
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I have a diagnosed heart condition known as long QT syndrome.
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I currently have an active infection.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~approximately 24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately 24 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Cohort B: Objective Response Rate (ORR)
Cohort D: ORR
Maximum Tolerated Dose (MTD)
+4 more
Secondary study objectives
AUC at steady state (AUCss) using F06 Formulation administered via feeding tube
AUC at steady state (AUCss) using F06 Formulation given intact
AUC at steady state (AUCss) using F1 Formulation
+59 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

7Treatment groups
Active Control
Group I: CNS tumors harboring- NTRK1/2/3, ROS1, ALKActive Control1 Intervention
Arm closed for further enrollment molecular alterations, including gene fusions Oral entrectinib (RXDX-101)
Group II: Extracranial solid tumors harboring NTRK1/2/3,Active Control1 Intervention
Arm closed for further enrollment ROS1, ALK non-gene fusion molecular alterations Oral entrectinib (RXDX-101)
Group III: Non-neuroblastoma, extracranial solid tumorsActive Control1 Intervention
Arm closed for further enrollment harboring - NTRK1/2/3, ROS1, ALK gene fusions Oral entrectinib (RXDX-101)
Group IV: NeuroblastomaActive Control1 Intervention
Arm closed for further enrollment Oral entrectinib (RXDX-101)
Group V: Any participant unable to swallow capsulesActive Control1 Intervention
Arm closed for further enrollment Any participant who otherwise meet all other eligibility criteria Oral entrectinib (RXDX-101)
Group VI: Expansion: CNS tumors harboring NTRK1/2/3, ROS1Active Control1 Intervention
gene fusions Oral entrectinib (RXDX-101)
Group VII: Expansion: Extracranial solid tumors harboring NTRK1/2/3, ROS1Active Control1 Intervention
NTRK 1,2,3 and ROS1 fusions Oral entrectinib (RXDX-101)

Find a Location

Who is running the clinical trial?

Hoffmann-La RocheLead Sponsor
2,463 Previous Clinical Trials
1,103,095 Total Patients Enrolled
Clinical TrialsStudy DirectorHoffmann-La Roche
2,233 Previous Clinical Trials
902,224 Total Patients Enrolled

Media Library

Entrectinib (Tyrosine Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT02650401 — Phase 1 & 2
Brain Tumor Research Study Groups: CNS tumors harboring- NTRK1/2/3, ROS1, ALK, Extracranial solid tumors harboring NTRK1/2/3,, Non-neuroblastoma, extracranial solid tumors, Neuroblastoma, Any participant unable to swallow capsules, Expansion: CNS tumors harboring NTRK1/2/3, ROS1, Expansion: Extracranial solid tumors harboring NTRK1/2/3, ROS1
Brain Tumor Clinical Trial 2023: Entrectinib Highlights & Side Effects. Trial Name: NCT02650401 — Phase 1 & 2
Entrectinib (Tyrosine Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02650401 — Phase 1 & 2
~3 spots leftby Jun 2025
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