Entrectinib for Solid Tumors

(STARTRK-NG Trial)

Recruiting in Palo Alto (17 mi)

+54 other locations

Age: < 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: Hoffmann-La Roche

No Placebo Group

Breakthrough Therapy

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?

This is an open-label, Phase 1/2 multicenter dose escalation study in pediatric patients with relapsed or refractory extracranial solid tumors (Phase 1), with additional expansion cohorts (Phase 2) in patients with primary brain tumors harboring NTRK1/2/3 or ROS1 gene fusions, and extracranial solid tumors harboring NTRK1/2/3 or ROS1 gene fusions.

Eligibility Criteria

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.

Inclusion Criteria

Participants must have measurable or evaluable disease, as defined by RANO for Phase 2 portion Part B

Participants must have archival tumor tissue from diagnosis or relapse

Participants must have measurable or evaluable disease, as defined by RECIST v1.1 for Phase 2 portion Part D

Exclusion Criteria

I do not have any severe health or mental conditions that could worsen by joining this study.

I have a family or personal history of bone disorders or weak bones.

I have not taken any seizure medications that affect enzymes in the last 14 days.

Participant Groups

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.

Group I: CNS tumors harboring- NTRK1/2/3, ROS1, ALK Active Control 1 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 Control 1 Intervention

Arm closed for further enrollment ROS1, ALK non-gene fusion molecular alterations Oral entrectinib (RXDX-101)

Group III: Non-neuroblastoma, extracranial solid tumors Active Control 1 Intervention

Arm closed for further enrollment harboring - NTRK1/2/3, ROS1, ALK gene fusions Oral entrectinib (RXDX-101)

Group IV: Neuroblastoma Active Control 1 Intervention

Arm closed for further enrollment Oral entrectinib (RXDX-101)

Group V: Any participant unable to swallow capsules Active Control 1 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, ROS1 Active Control 1 Intervention

gene fusions Oral entrectinib (RXDX-101)

Group VII: Expansion: Extracranial solid tumors harboring NTRK1/2/3, ROS1 Active Control 1 Intervention

NTRK 1,2,3 and ROS1 fusions Oral entrectinib (RXDX-101)

Entrectinib is already approved in United States, European Union, Japan for the following indications:

🇺🇸 Approved in United States as Rozlytrek for:

• Metastatic non-small cell lung cancer (mNSCLC) with a neurotrophic receptor tyrosine kinase (NTRK) gene fusion
• Solid tumors with a NTRK gene fusion

🇪🇺 Approved in European Union as Rozlytrek for:

• Solid tumours with a NTRK gene fusion
• Metastatic non-small cell lung cancer (NSCLC) with a NTRK gene fusion

🇯🇵 Approved in Japan as Rozlytrek for:

• Solid tumours with a NTRK gene fusion

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

UCSF Benioff Children's Hospital San Francisco, CA

Children's Hospital Colorado Aurora, CO

Egleston Children's Hospital at Emory University Atlanta Atlanta, GA

University of Chicago Chicago, IL

More Trial Locations

Who Is Running the Clinical Trial?

Hoffmann-La Roche Lead Sponsor

References