← Back to Search

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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up approximately 24 months
Awards & highlights

STARTRK-NG Trial 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.Check my eligibility
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.See study design
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.

STARTRK-NG Trial Eligibility Criteria

Inclusion Criteria

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

STARTRK-NG Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Cohort B: Objective Response Rate (ORR)
Cohort D: ORR
Maximum Tolerated Dose (MTD)
+4 more
Secondary outcome measures
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

STARTRK-NG Trial Design

7Treatment groups
Active Control
Group I: NeuroblastomaActive Control1 Intervention
Arm closed for further enrollment Oral entrectinib (RXDX-101)
Group II: 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 III: 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 IV: 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 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
2,426 Previous Clinical Trials
1,089,063 Total Patients Enrolled
Clinical TrialsStudy DirectorHoffmann-La Roche
2,197 Previous Clinical Trials
888,491 Total Patients Enrolled

Media Library

Entrectinib (Tyrosine Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT02650401 — Phase 1 & 2
Brain Tumor Research Study Groups: Neuroblastoma, CNS tumors harboring- NTRK1/2/3, ROS1, ALK, Extracranial solid tumors harboring NTRK1/2/3,, Non-neuroblastoma, extracranial solid tumors, 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

Frequently Asked Questions

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

What impact is this research intended to have?

"This clinical trial aims to determine the Recommended Phase 2 Dose (RP2D) Of Minitablets/F15 Formulation In Pediatric Participants Unable To Swallow Intact Capsules over a 6 month period. The secondary objectives of this study include assessment of TTR using RANO, evaluation of Overall Survival with RECIST v1.1, and measuring PFS through RANO for Cohorts B or E."

Answered by AI

Are there any existing studies that analyze CNS tumors with NTRK1/2/3 and ROS1 mutations?

"Currently, 18 clinical trials for Expansion: CNS tumors harboring NTRK1/2/3, ROS1 are in progress with 3 of those studies reaching Phase Three. Although Portland is a hub of research activity surrounding this condition, there are 1,578 locations across the globe conducting related medical experiments."

Answered by AI

To which neurological malignancies is Expansion: CNS tumors harboring NTRK1/2/3, ROS1 typically administered?

"Expansion: The use of CNS tumors featuring NTRK1/2/3, ROS1 has been widely adopted as a therapeutic intervention to address various conditions and diseases such as neoplasms, malignant tumours, and solid masses."

Answered by AI

What is the maximum number of participants accepted for this research?

"Unfortunately, this clinical trial is no longer recruiting subjects. Initially posted on May 3rd 2016 and last updated October 17th 2022, patients need to look elsewhere if they hope to participate in a medical study. Fortunately there are currently 2645 trials related to tumors (solid) and 18 studies specifically for CNS tumours with NTRK1/2/3 or ROS1 actively enrolling participants."

Answered by AI

What are the eligibility criteria for participating in this clinical experiment?

"Eligibility for this trial requires that applicants possess tumors of a solid nature and are between infancy and 18 years old. A total of 68 participants are needed to complete the study."

Answered by AI

Are there any vacancies in the research cohort?

"Clinicaltrials.gov reveals that the trial, which was initially posted on May 3rd 2016 and last updated October 17th 2022 is not currently seeking participants. Nonetheless, 2663 other trials are recruiting patients presently."

Answered by AI

Is this trial open to elderly individuals?

"This clinical trial will include participants between the ages of infancy and 18. Presently, 356 trials are recruiting patients aged 0-18 whereas 2438 studies target those over 65 years old."

Answered by AI

Is this experiment unprecedented in its scope?

"Since 2015, Expansion: CNS tumors harboring NTRK1/2/3, ROS1 has been subject to extensive research. Hoffmann-La Roche sponsored the first trial which was conducted in 2015 with 700 participants and eventually led to Phase 2 drug approval. Presently, 18 studies are ongoing across 482 cities and 54 countries."

Answered by AI
~9 spots leftby Jun 2025