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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

Study acronym: STARTRK-NG
StatusActive, Not Recruiting
PhasePhase 1/2
Started2016-05-03
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 12 months later Jun 30, 2026 → Jun 30, 2027
See other at-risk trials from Roche/Genentech

Amendment history

The 50 most recent of 73 record versions are accounted for below. See every version on ClinicalTrials.gov ↗

2026-09-24
Primary completion pushed: 2026-06-30 → 2027-06-30
Completion pushed: 2026-06-30 → 2027-06-30
2026-06-22
2 amendments v71-v72
2 re-verifications since 2026-03-24, no change to tracked fields
2025-12-22
Study Status, Contacts/Locations v70
Study sites27→26
2025-09-23
Study Status, Contacts/Locations v69
Study sites27 entries, revised
Royal Marsden NHSHospital Foundation Trust(Sutton)
2025-06-25
Study Identification, Study Status, Contacts/Locations v68
Primary completion date2025-06-15→2026-06-30
Completion date2025-06-15→2026-06-30
Study sites26→27
Show 45 earlier versions
2025-03-24
Study Status, Contacts/Locations, IPDSharing v67
Study sitesdetails revised at 1 of 26 sites
2024-12-24
Study Status, Contacts/Locations v66
Study sites40→26
2024-09-26
3 amendments v63-v65
3 re-verifications since 2024-03-28, no change to tracked fields
2024-02-22
Study Status v62
Primary completion date2023-03-08→2025-06-15
2024-01-02
Study Status v61
Primary completion date2022-12-15→2023-03-08
2023-10-05
3 amendments v58-v60
3 re-verifications since 2023-04-17, no change to tracked fields
2023-01-13
Study Status, Study Design, Contacts/Locations v57
Primary completion dateestimated 2027-08-30→confirmed 2022-12-15
Completion date2027-08-30→2025-06-15
Enrollment targetestimated 68→confirmed 69
Study sites39→40
2022-10-17
Recruiting→Active, Not Recruiting Study Status, Contacts/Locations v56
Trial statusRecruiting→Active, Not Recruiting
Study sitesdetails revised at 39 of 39 sites
2022-09-22
Active, Not Recruiting→Recruiting Study Status, Contacts/Locations v55
Trial statusActive, Not Recruiting→Recruiting
Study sitesdetails revised at 39 of 39 sites
2022-08-29
Recruiting→Active, Not Recruiting Study Status, Contacts/Locations v54
Trial statusRecruiting→Active, Not Recruiting
Study sitesdetails revised at 39 of 39 sites
2022-08-24
2 amendments v52-v53
2 re-verifications since 2022-07-26, no change to tracked fields
2022-06-29
Active, Not Recruiting→Recruiting Study Status, Contacts/Locations v51
Trial statusActive, Not Recruiting→Recruiting
Primary completion date2029-08-30→2027-08-30
Completion date2029-08-30→2027-08-30
Study sitesdetails revised at 39 of 39 sites
2022-06-21
Recruiting→Active, Not Recruiting Study Status, Contacts/Locations v50
Trial statusRecruiting→Active, Not Recruiting
Study sitesdetails revised at 39 of 39 sites
2022-05-31
Study Status v49
Re-verified, no change to tracked fields
2022-05-01
Study Status, Outcome Measures, Contacts/Locations v48
Secondary endpoints26 to 62 entries
Cohort A, D, or E: Clinical Benefit Rate (CBR) Cohort B or E: CBR Cohort C: CBR Cohort A, D, or E: Progression-free Survival (PFS) Cohort B or E: PFS Cohort C: PFS Cohort A, D, or E: Overall Survival (OS) Cohort B or E: OS Cohort A, D, or E: ORR Cohort B or E: ORR Cohort C: ORR Cohort A, D, or E: Time to response (TTR) Cohort B or E: TTR Cohort C: TTR Cohort A, D, or E: Duration of Response (DOR) TimeCohort toB responseor E: DOR Cohort C: DOR Phase 2 Participants with NTRK1/2/3 or ROS1 gene fusions (TTRCohort B or E): ORR ClinicalPhase Benefit2 RateParticipants with NTRK1/2/3 or ROS1 gene fusi [...] [...]
Primary endpoints6 to 7 entries
Cohort B: Objective Response Rate (ORR) Cohort D: ORR
Study sites39 entries, revised
Hopital Purpan; PédiatriePediatrie - HématologieHematologie - Oncologie pédiatriquepediatrique UniversitätsklinikumUniversitaetsklinikum Heidelberg Hospital Infantil Universitario NiñoNino Jesus; Servicio de Onco-hematologia
2022-02-08
2 amendments v46-v47
2 re-verifications since 2022-01-14, no change to tracked fields
2021-11-09
Study Status, Contacts/Locations v45
Study sites41→39
2021-09-28
2 amendments v43-v44
2 re-verifications since 2021-08-16, no change to tracked fields
2021-06-22
Study Status, Contacts/Locations v42
Study sitesdetails revised at 3 of 41 sites
2021-04-26
Study Status, Contacts/Locations v41
Study sitesdetails revised at 4 of 41 sites
2021-03-18
Study Status, Contacts/Locations v40
Study sites40→41
2021-02-01
Study Status v39
Re-verified, no change to tracked fields
2020-12-03
Study Status, Contacts/Locations v38
Study sites39→40
2020-10-29
Study Status, Contacts/Locations v37
Primary completion date2023-06-01→2029-08-30
Completion date2023-06-01→2029-08-30
Study sites35→39
2020-09-24
Study Status, Eligibility, Contacts/Locations v36
Study sites29→35
2020-08-20
Study Status v35
Re-verified, no change to tracked fields
2020-07-21
Study Status, Contacts/Locations v34
Study sites28→29
2020-06-19
Study Status, Contacts/Locations v33
Study sites27→28
2020-06-01
Study Status, Contacts/Locations v32
Study sites24→27
2020-04-30
Study Identification, Study Status, Oversight, Study Description, Study Design, Arms and Interventions, Outcome Measures, Eligibility, Contacts/Locations v31
PhasePhase 1→Phase 1/2
Enrollment target65→68
Study sites21→24
Eligibility criteria+1,289 characters
Inclusion Criteria: Ability to swallow capsules unless enrolled in Part E Body surface area (BSA): Subjects must have a body surface area ≥ 0.45 m2 at the time of the study enrollment, unless enrolled in Part E Disease status: Phase Subjects1 portion (closed): Participants must have measurable or evaluable disease, as defined by RECIST v1.1 Phase 2 portion: Part B: Participants must have measurable or evaluable disease, as defined by RANO Part C (closed): Participants must have measurable or evaluable disease, as defined by RECIST v1.1 ± Curie Scale Part D: Participants must have measurable or [...] [...]
Secondary endpoints8 to 26 entries
Maximum observed plasma drug concentration (Cmax) using F1 Formulation Maximum observed plasma drug concentration (Cmax) using F06 Formulation given intact Maximum observed plasma drug concentration (Cmax) using F06 Formulation administered via feeding tube Maximum observed plasma drug concentration (Cmax) using minitablets/F15 Time to Cmax, by inspection (Tmax) using F1 Formulation CssTime to Cmax, by inspection (Tmax) using F06 Formulation given intact Time to Cmax, by inspection (Tmax) using F06 Formulation administered via feeding tube Time to Cmax, by inspection (Tmax) using minitablets/F [...] [...]
Primary endpoints3 to 6 entries
Recommended Phase 2 Dose (RP2D) Of Minitablets/F15 Formulation In Pediatric Participants Unable To Swallow Intact Capsules Recommended Phase 2 Dose (RP2D) of F06 Formulation In Pediatric In Participants Dosed Via Feeding Tube (Nasogastric Tube Or Gastric Tube) Recommended Phase 2 Dose (RP2D) of F06 Formulation In Pediatric Partic [...]
Study title-35 characters
Study Of Entrectinib (Rxdx-101) in Children and Adolescents With NoLocally CurativeAdvanced First-LineOr Treatment Option, Recurrent or RefractoryMetastatic Solid Or Primary CNS Tumors And/Or PrimaryWho CnsHave Tumors,No WithSatisfactory orTreatment Without Trk, Ros1, or Alk FusionsOptions
2020-03-12
Study Status, Contacts/Locations v30
Study sitesdetails revised at 1 of 21 sites
2020-02-04
7 amendments v23-v29
7 re-verifications since 2019-07-09, no change to tracked fields
Roche/Genentech
364 trials monitored
See 34 trials at risk
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.
Trial Details
NCT Number NCT02650401
Lead Sponsor Hoffmann-La Roche
Conditions Solid Tumors, CNS Tumors
Enrollment 69 participants
Start Date 2016-05-03
Primary Completion 2027-06-30 (estimated)
Study Completion 2027-06-30 (estimated)
Updated on ClinicalTrials.gov 2026-09-23