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Study Of Entrectinib (Rxdx-101) in Children and Adolescents With Locally Advanced Or Metastatic Solid Or Primary CNS Tumors And/Or Who Have No Satisfactory Treatment Options (STARTRK-NG)
EU CTIS ID: 2023-505088-35-00
What this study is testing
To determine the maximum tolerated dose (MTD), or recommended Phase 2 dose (RP2D), of F1 entrectinib formulation in pediatric patients with relapsed or refractory solid tumors (Cohort A). To confirm RP2D of F06 entrectinib formulation in pediatric patients able to swallow intact capsules and in patients dosed via feeding tube (nasogastric tube or gastric tube). To confirm RP2D of minitablet formulation in pediatric patients unable to swallow intact capsules. To evaluate efficacy of entrectinib as assessed by objective response rate (ORR) in the efficacy evaluable patients from Phase II dose expansion (Cohorts B and D) harboring NTRK1/2/3 or ROS1 gene fusions. Responses will be evaluated with use of the Response Assessment in Neuro-Oncology Criteria (RANO) for primary CNS tumors and RECIST v1.1 in patients with extracranial solid tumors, as assessed by blinded independent central review (BICR)
- Phase I and Phase II (Integrated)- Other
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Sex and age: male or female aged from birth to age < 18 years
- Disease status: Phase 1 portion (closed): Patients must have measurable or evaluable disease Phase 2 portion: Cohort B: Patients must have measurable or evaluable disease as defined by RANO Cohort C (closed) and D: Patients must have measurable or evaluable disease as defined per RECIST v1.1±Curie Scale Cohort D: Patients must have measurable or evaluable disease, Cohort E (closed): Patients must have measurable or evaluable disease and be assessed according to tumor type as defined per RECIST v1.1±Curie Scale or RANO
- Tumor types included below harboring NTRK1/2/3 or ROS1 gene fusions as determined locally by an appropriately validated assay performed in a Clinical Laboratory Improvement Amendments (CLIA)-certified or equivalently-accredited diagnostic laboratory, or centrally by a Foundation Medicine Clinical Trial Assay or the alternative, approved central laboratory for that region: Phase 1 portion: Cohort A: Relapsed or refractory extracranial solid tumors Phase 2 portion: Cohort B: Primary brain tumors with NTRK1/2/3 or ROS1 gene fusions Cohort D: Extracranial solid tumors with NTRK1/2/3 or ROS1 gene fusions
- Histologic/molecular diagnosis of malignancy at diagnosis or the time of relapse
- For patients enrolled via local molecular testing, an archival tumor tissue from diagnosis or, preferably, from relapsed disease is required to be submitted for independent central testing at Foundation Medicine, Inc. laboratory or the alternative, approved central assay laboratory for that region
- Performance status: Lansky or Karnofsky score ≥ 60% and minimum life expectancy of at least 4 weeks
You likely can't join if
- Current participation in another therapeutic clinical trial
- Known congenital long QT syndrome
- History of recent (3 months) symptomatic congestive heart failure or ejection fraction ≤50% at screening
- Known active infections (bacterial, fungal, or viral)
- All Phase 2 patients: Prior treatment with approved or investigational tyrosine receptor kinase inhibitor (TRK) or ROS1 inhibitors
- Incomplete recovery from acute effects of any surgery prior to treatment
The study team makes the final eligibility decision.
Where it's taking place
- United Kingdom
- Canada
- United States
- Hong Kong
- China
- Korea, Republic of
- Taiwan
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 0-17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United Kingdom; Canada; United States; Hong Kong; China; Korea, Republic of and 1 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.