Solid TumorsPhase 1/2STARTRK-NGNCT02650401
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
A Phase 1/2 study testing Entrectinib in people with Solid Tumors and CNS Tumors, run by Hoffmann-La Roche at 26 sites in 9 countries.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 0 to 18 years
- Conditions the study is for
- Solid Tumors, CNS Tumors
- What is being tested?
- Entrectinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- 26 sitesin 9 countries
- Study dates
- 3 May 2016to 30 Jun 2027
- Phase
- Phase 1/2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Disease status:
- Phase 1 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 evaluable disease, as defined by RECIST v1.1
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- Part E (closed): Participants must have measurable or evaluable disease, as defined by RECIST v1.1 ± Curie Scale or RANO
- Tumor type:
- Phase 1 portion:
- Part A: Relapsed or refractory extracranial solid tumors
- Phase 2 portion
- Part B: Primary brain tumors with NTRK1/2/3 or ROS1 gene fusions; gene fusions are defined as those predicted to translate into a fusion protein with a functional TRKA/B/C or ROS1 kinase domain, without a concomitant second oncodriver as determined by a nucleic acid-based diagnostic testing method
- Part D: Extracranial solid tumors (including NB) with NTRK1/2/3 or ROS1 gene fusions; gene fusions are defined as those predicted to translate into a fusion protein with a functional TRKA/B/C or ROS1 kinase domain, without a concomitant second oncodriver as determined by a nucleic acid-based diagnostic testing method
- Histologic/molecular diagnosis of malignancy at diagnosis or the time of relapse
- Archival tumor tissue from diagnosis or, preferably, at relapse
- Performance status: Lansky or Karnofsky score ≥ 60% and minimum life expectancy of at least 4 weeks
- Prior therapy: Participants must have a disease that is locally advanced, metastatic, or where surgical resection is likely to result in severe morbidity, and who have no satisfactory treatment options for solid tumors and primary CNS tumors that are neurotrophic tyrosine receptor kinase (NTRK) or ROS1 fusion-positive
- Participants must have recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to enrollment
- Adequate organ and neurologic function
- Females of childbearing potential must have a negative serum pregnancy test during screening and be neither breastfeeding nor intending to become pregnant during study participation. Agreement to remain abstinent or use use combined contraceptive methods prior to study entry, for the duration of study participation and in the following 90 days after discontinuation of study treatment.
- For male participants with a female partner of childbearing potential or a pregnant female partner: Agreement to remain abstinent or use a condom during the treatment period and for at least 3 months after the last dose of study drug
Who cannot join
- Receiving other experimental therapy
- Known congenital long QT syndrome
- History of recent (3 months) symptomatic congestive heart failure or ejection fraction ≤50% at screening
- Known active infections
- 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.
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- Prior treatment with approved or investigational TRK or ROS1 inhibitors
- Known hypersensitivity to entrectinib or any of the other excipients of the investigational medicinal product
- Patients with NB with bone marrow space-only disease
- Incomplete recovery from acute effects of any surgery prior to treatment.
- Active gastrointestinal disease or other malabsorption syndromes that would impact drug absorption.
- Other severe acute or chronic medical or psychiatric condition or lab abnormality that may increase the risk associated with study participation, drug administration or may interfere with the interpretation of study results.
Trial locations and contacts
26 sites in 9 countries.
26 sites in 9 countries
United States15 sites
Egleston Children's Hospital at Emory University Atlanta
Atlanta, Georgia, 30322
Children's Hospital Colorado
Aurora, Colorado, 80045
Johns Hopkins University
Baltimore, Maryland, 21205
Dana Farber Cancer Institute
Boston, Massachusetts, 02215
University of Chicago
Chicago, Illinois, 60637
Nationwide Children's Hospital
Columbus, Ohio, 43205
Texas Children's Cancer and Hematology Center
Houston, Texas, 77030
University of California San Diego
La Jolla, California, 92093-0706
St. Jude Children'S Research Hospital
Memphis, Tennessee, 38105
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
Oregon Health & Science Uni
Portland, Oregon, 97239
Primary Children's Hospital
Salt Lake City, Utah, 84113
UCSF Benioff Children's Hospital
San Francisco, California, 94158
Washington University,St. Louis Children's Hospital
St Louis, Missouri, 63110
China2 sites
Beijing Children's Hospital, Capital Medical University
Beijing
Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200082
France2 sites
Centre Leon Berard
Lyon, 69373
Hôpital de la Timone, Oncologie Pédiatrique
Marseille, 13385
United Kingdom2 sites
Royal Marsden Hospital (Sutton)
London, SW3 6JJ
Royal Victoria Infirmary
Newcastle upon Tyne, NE1 4LP
Germany1 site
Universitaetsklinikum Heidelberg
Heidelberg, Baden-Wurttemberg, 69120
Italy1 site
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, Lombardy, 20133
About this study
Official title: A Phase 1/2, Open-Label, Dose-Escalation And Expansion Study Of Entrectinib (Rxdx-101) In Pediatrics With Locally Advanced Or Metastatic Solid Or Primary CNS Tumors And/Or Who Have No Satisfactory Treatment Options
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.
- Conditions
- Solid Tumors, CNS Tumors
- Being tested
- Entrectinib
- Keywords
- TRK, Tyrosine kinase, NTRK, NTRK1, NTRK2, NTRK3, ROS1, ALK, Pediatric, Relapsed, Refractory, Solid Tumor, Metastatic Cancer, Gene rearrangement, Neuroblastoma, Infantile fibrosarcoma, Secretory breast cancer, Congenital mesoblastic nephroma, Pontine glioma, Brain tumors
- Medical subject headings
- Central Nervous System Neoplasms, Recurrence, Neoplasm Metastasis, Neuroblastoma, Nephroma, Mesoblastic, Brain Neoplasms, Sarcoma, Sarcoma, Ewing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EntrectinibDrug
Also called RXDX-101
TRKA/B/C, ROS1, and ALK inhibitor
| Study group | Role | What they receive |
|---|---|---|
| Extracranial solid tumors harboring NTRK1/2/3, | Active comparator | Arm closed for further enrollment
ROS1, ALK non-gene fusion molecular alterations
Oral entrectinib (RXDX-101) Receives: Drug: Entrectinib |
| CNS tumors harboring- NTRK1/2/3, ROS1, ALK | Active comparator | Arm closed for further enrollment
molecular alterations, including gene fusions
Oral entrectinib (RXDX-101) Receives: Drug: Entrectinib |
| Neuroblastoma | Active comparator | Arm closed for further enrollment
Oral entrectinib (RXDX-101) Receives: Drug: Entrectinib |
| Non-neuroblastoma, extracranial solid tumors | Active comparator | Arm closed for further enrollment
harboring - NTRK1/2/3, ROS1, ALK gene fusions
Oral entrectinib (RXDX-101) Receives: Drug: Entrectinib |
| Any participant unable to swallow capsules | Active comparator | Arm closed for further enrollment
Any participant who otherwise meet all other eligibility criteria
Oral entrectinib (RXDX-101) Receives: Drug: Entrectinib |
| Expansion: CNS tumors harboring NTRK1/2/3, ROS1 | Active comparator | gene fusions
Oral entrectinib (RXDX-101) Receives: Drug: Entrectinib |
| Expansion: Extracranial solid tumors harboring NTRK1/2/3, ROS1 | Active comparator | NTRK 1,2,3 and ROS1 fusions
Oral entrectinib (RXDX-101) Receives: Drug: Entrectinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Tolerated Dose (MTD)
Assessed by National Cancer Institute Common Terminology for Adverse Events Criteria (NCI CTCAE v4.03)
Measured: Approximately 6 months
Recommended Phase 2 Dose (RP2D) of F1 Formulation In Pediatric Participants Able To Swallow Intact Capsules
Assessed by NCI CTCAE v4.03
Measured: Approximately 6 months
Recommended Phase 2 Dose (RP2D) of F06 Formulation In Pediatric Participants Able To Swallow Intact Capsules
Assessed by NCI CTCAE v4.03
Measured: Approximately 6 months
Recommended Phase 2 Dose (RP2D) of F06 Formulation In Pediatric In Participants Dosed Via Feeding Tube (Nasogastric Tube Or Gastric Tube)
Assessed by NCI CTCAE v4.03
Measured: Approximately 6 months
Recommended Phase 2 Dose (RP2D) Of Minitablets/F15 Formulation In Pediatric Participants Unable To Swallow Intact Capsules
Assessed by NCI CTCAE v4.03
Measured: Approximately 6 months
Cohort B: Objective Response Rate (ORR)
Assessed by RANO per the BICR
Measured: Approximately 6 months
Cohort D: ORR
Assessed by RECIST v1.1 per the BICR
Measured: Approximately 6 months
Secondary outcomes (62)
Safety and Tolerability - AE, ECG and Labs assessed by NCI CTCAE v4.03
AE, ECG and Labs assessed by NCI CTCAE v4.03
Measured: Approximately 24 months
Maximum observed plasma drug concentration (Cmax) using F1 Formulation
Assessed by plasma concentrations obtained on Days 1, 2, 8, 15, 22 (Cycle 1), Days 1, 2 (Cycle 2) and on Day 1 of every cycle thereafter
Measured: Approximately 24 months
Maximum observed plasma drug concentration (Cmax) using F06 Formulation given intact
Assessed by plasma concentrations obtained on Days 1, 2, 8, 15, 22 (Cycle 1), Days 1, 2 (Cycle 2) and on Day 1 of every cycle thereafter
Measured: Approximately 24 months
Maximum observed plasma drug concentration (Cmax) using F06 Formulation administered via feeding tube
Assessed by plasma concentrations obtained on Days 1, 2, 8, 15, 22 (Cycle 1), Days 1, 2 (Cycle 2) and on Day 1 of every cycle thereafter
Measured: Approximately 24 months
Maximum observed plasma drug concentration (Cmax) using minitablets/F15
Assessed by plasma concentrations obtained on Days 1, 2, 8, 15, 22 (Cycle 1), Days 1, 2 (Cycle 2) and on Day 1 of every cycle thereafter
Measured: Approximately 24 months
Time to Cmax, by inspection (Tmax) using F1 Formulation
Assessed by plasma concentrations obtained on Days 1, 2, 8, 15, 22 (Cycle 1), Days 1, 2 (Cycle 2) and on Day 1 of every cycle thereafter
Measured: Approximately 24 months
Time to Cmax, by inspection (Tmax) using F06 Formulation given intact
Assessed by plasma concentrations obtained on Days 1, 2, 8, 15, 22 (Cycle 1), Days 1, 2 (Cycle 2) and on Day 1 of every cycle thereafter
Measured: Approximately 24 months
Time to Cmax, by inspection (Tmax) using F06 Formulation administered via feeding tube
Assessed by plasma concentrations obtained on Days 1, 2, 8, 15, 22 (Cycle 1), Days 1, 2 (Cycle 2) and on Day 1 of every cycle thereafter
Measured: Approximately 24 months
Time to Cmax, by inspection (Tmax) using minitablets/F15
Assessed by plasma concentrations obtained on Days 1, 2, 8, 15, 22 (Cycle 1), Days 1, 2 (Cycle 2) and on Day 1 of every cycle thereafter
Measured: Approximately 24 months
AUC at steady state (AUCss) using F1 Formulation
Assessed by plasma concentrations obtained on Days 1, 2, 8, 15, 22 (Cycle 1), Days 1, 2 (Cycle 2) and on Day 1 of every cycle thereafter
Measured: Approximately 24 months
AUC at steady state (AUCss) using F06 Formulation given intact
Assessed by plasma concentrations obtained on Days 1, 2, 8, 15, 22 (Cycle 1), Days 1, 2 (Cycle 2) and on Day 1 of every cycle thereafter
Measured: Approximately 24 months
AUC at steady state (AUCss) using F06 Formulation administered via feeding tube
Assessed by plasma concentrations obtained on Days 1, 2, 8, 15, 22 (Cycle 1), Days 1, 2 (Cycle 2) and on Day 1 of every cycle thereafter
Measured: Approximately 24 months
AUC at steady state (AUCss) using minitablets/F15
Assessed by plasma concentrations obtained on Days 1, 2, 8, 15, 22 (Cycle 1), Days 1, 2 (Cycle 2) and on Day 1 of every cycle thereafter
Measured: Approximately 24 months
Terminal half life (t½) using F1 Formulation
Assessed by plasma concentrations obtained on Days 1, 2, 8, 15, 22 (Cycle 1), Days 1, 2 (Cycle 2) and on Day 1 of every cycle thereafter
Measured: Approximately 24 months
Terminal half life (t½) using F06 Formulation given intact
Assessed by plasma concentrations obtained on Days 1, 2, 8, 15, 22 (Cycle 1), Days 1, 2 (Cycle 2) and on Day 1 of every cycle thereafter
Measured: Approximately 24 months
Terminal half life (t½) using F06 Formulation administered via feeding tube
Assessed by plasma concentrations obtained on Days 1, 2, 8, 15, 22 (Cycle 1), Days 1, 2 (Cycle 2) and on Day 1 of every cycle thereafter
Measured: Approximately 24 months
Terminal half life (t½) using minitablets/F15
Assessed by plasma concentrations obtained on Days 1, 2, 8, 15, 22 (Cycle 1), Days 1, 2 (Cycle 2) and on Day 1 of every cycle thereafter
Measured: Approximately 24 months
Area under the drug concentration by time curve (AUC) using F1 Formulation
Assessed by plasma concentrations obtained on Days 1, 2, 8, 15, 22 (Cycle 1), Days 1, 2 (Cycle 2) and on Day 1 of every cycle thereafter
Measured: Approximately 24 months
Area under the drug concentration by time curve (AUC) using F06 Formulation given intact
Assessed by plasma concentrations obtained on Days 1, 2, 8, 15, 22 (Cycle 1), Days 1, 2 (Cycle 2) and on Day 1 of every cycle thereafter
Measured: Approximately 24 months
Area under the drug concentration by time curve (AUC) using F06 Formulation administered via feeding tube
Assessed by plasma concentrations obtained on Days 1, 2, 8, 15, 22 (Cycle 1), Days 1, 2 (Cycle 2) and on Day 1 of every cycle thereafter
Measured: Approximately 24 months
Area under the drug concentration by time curve (AUC) using minitablets/F15
Assessed by plasma concentrations obtained on Days 1, 2, 8, 15, 22 (Cycle 1), Days 1, 2 (Cycle 2) and on Day 1 of every cycle thereafter
Measured: Approximately 24 months
Cohort A, D, or E: Clinical Benefit Rate (CBR)
Assessed by RECIST v1.1 per the BICR and investigator
Measured: Approximately 6 months
Cohort B or E: CBR
Assessed by RANO per the BICR and investigator
Measured: Approximately 6 months
Cohort C: CBR
Assessed by the Curie scale per the BICR and investigator
Measured: Approximately 6 months
Cohort A, D, or E: Progression-free Survival (PFS)
Assessed by RECIST v1.1 per the BICR and investigator
Measured: Approximately 6 months
Cohort B or E: PFS
Assessed by RANO per the BICR and investigator
Measured: Approximately 6 months
Cohort C: PFS
Assessed by the Curie scale per the BICR and investigator
Measured: Approximately 6 months
Cohort A, D, or E: Overall Survival (OS)
Assessed by RECIST v1.1
Measured: Approximately 6 months
Cohort B or E: OS
Assessed by RANO
Measured: Approximately 6 months
Cohort A, D, or E: ORR
Assessed by RECIST v1.1 per the BICR and investigator
Measured: Approximately 6 months
Cohort B or E: ORR
Assessed by RANO per the BICR and investigator
Measured: Approximately 6 months
Cohort C: ORR
Assessed by the Curie scale per the BICR and investigator
Measured: Approximately 6 months
Cohort A, D, or E: Time to response (TTR)
Assessed by RECIST v1.1 per the BICR and investigator
Measured: Approximately 6 months
Cohort B or E: TTR
Assessed by RANO per the BICR and investigator
Measured: Approximately 6 months
Cohort C: TTR
Assessed by the Curie scale per the BICR and investigator
Measured: Approximately 6 months
Cohort A, D, or E: Duration of Response (DOR)
Assessed by RECIST v1.1 per the BICR and investigator
Measured: Approximately 6 months
Cohort B or E: DOR
Assessed by RANO per the BICR and investigator
Measured: Approximately 6 months
Cohort C: DOR
Assessed by the Curie scale per the BICR and investigator
Measured: Approximately 6 months
Phase 2 Participants with NTRK1/2/3 or ROS1 gene fusions (Cohort B or E): ORR
Assessed by RANO per the investigator
Measured: Approximately 6 months
Phase 2 Participants with NTRK1/2/3 or ROS1 gene fusions (Cohort D or E): ORR
Assessed by RECIST v1.1 per the investigator
Measured: Approximately 6 months
Phase 1/2 Participants with NTRK1/2/3 gene fusions (Cohort A, D, or E): ORR
Assessed by RECIST v1.1 per the BICR and investigator
Measured: Approximately 6 months
Phase 1/2 Participants with NTRK1/2/3 gene fusions (Cohort B or E): ORR
Assessed by RANO per the BICR and investigator
Measured: Approximately 6 months
Phase 1/2 Participants with ROS1 gene fusions (Cohort A, D, or E): ORR
Assessed by RECIST v1.1 per the BICR and investigator
Measured: Approximately 6 months
Phase 1/2 Participants with ROS1 gene fusions (Cohort B or E): ORR
Assessed by RANO per the BICR and investigator
Measured: Approximately 6 months
Phase 1/2 Participants with NTRK1/2/3 or ROS1 gene fusions (Cohort A, D, or E): ORR
Assessed by RECIST v1.1 per the BICR and investigator
Measured: Approximately 6 months
Phase 1/2 Participants with NTRK1/2/3 or ROS1 gene fusions (Cohort B or E): ORR
Assessed by RANO per the BICR and investigator
Measured: Approximately 6 months
Phase 2 Participants with NTRK1/2/3 or ROS1 gene fusions (Cohort B or E): DOR
Assessed by RANO per the BICR and investigator
Measured: Approximately 6 months
Phase 2 Participants with NTRK1/2/3 or ROS1 gene fusions (Cohort D or E): DOR
Assessed by RECIST v1.1 per the BICR and investigator
Measured: Approximately 6 months
Phase 1/2 Participants with NTRK1/2/3 gene fusions (Cohort A, D, or E): DOR
Assessed by RECIST v1.1 per the BICR and investigator
Measured: Approximately 6 months
Phase 1/2 Participants with NTRK1/2/3 gene fusions (Cohort B or E): DOR
Assessed by RANO per the BICR and investigator
Measured: Approximately 6 months
Phase 1/2 Participants with ROS1 gene fusions (Cohort A, D, or E): DOR
Assessed by RECIST v1.1 per the BICR and investigator
Measured: Approximately 6 months
Phase 1/2 Participants with ROS1 gene fusions (Cohort B or E): DOR
Assessed by RANO per the BICR and investigator
Measured: Approximately 6 months
Phase 1/2 Participants with NTRK1/2/3 or ROS1 gene fusions (Cohort A, D, or E): DOR
Assessed by RECIST v1.1 per the BICR and investigator
Measured: Approximately 6 months
Phase 1/2 Participants with NTRK1/2/3 or ROS1 gene fusions (Cohort B or E): DOR
Assessed by RANO per the BICR and investigator
Measured: Approximately 6 months
Phase 2 Participants with NTRK1/2/3 or ROS1 gene fusions (Cohort B or E): TTR
Assessed by RANO per the BICR and investigator
Measured: Approximately 6 months
Phase 2 Participants with NTRK1/2/3 or ROS1 gene fusions (Cohort D or E): TTR
Assessed by RECIST v1.1 per the BICR and investigator
Measured: Approximately 6 months
Phase 1/2 Participants with NTRK1/2/3 gene fusions (Cohort A, D, or E): TTR
Assessed by RECIST v1.1 per the BICR and investigator
Measured: Approximately 6 months
Phase 1/2 Participants with NTRK1/2/3 gene fusions (Cohort B or E): TTR
Assessed by RANO per the BICR and investigator
Measured: Approximately 6 months
Phase 1/2 Participants with ROS1 gene fusions (Cohort A, D, or E): TTR
Assessed by RECIST v1.1 per the BICR and investigator
Measured: Approximately 6 months
Phase 1/2 Participants with ROS1 gene fusions (Cohort B or E): TTR
Assessed by RANO per the BICR and investigator
Measured: Approximately 6 months
Phase 1/2 Participants with NTRK1/2/3 or ROS1 gene fusions (Cohort A, D, or E): TTR
Assessed by RECIST v1.1 per the BICR and investigator
Measured: Approximately 6 months
Phase 1/2 Participants with NTRK1/2/3 or ROS1 gene fusions (Cohort B or E): TTR
Assessed by RANO per the BICR and investigator
Measured: Approximately 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2016 (estimated)
- Study start3 May 2016
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Solid TumorsStudies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02650401
- Sponsor's protocol ID
- RXDX-101-03
- Other IDs
- CO40778, 2023-505088-35-00, 2023
- Acronym
- STARTRK-NG
- Status last verified
- Sep 2026
- First submitted
- 4 Jan 2016
- Last updated
- 23 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data\_sharing.
Publications
Desai AV, Bagchi A, Armstrong AE, van Tilburg CM, Basu EM, Robinson GW, Wang H, Casanova M, Andre N, Campbell-Hewson Q, Wu Y, Cardenas A, Ci B, Ryklansky C, Devlin CE, Meneses-Lorente G, Wulff J, Hutchinson KE, Gajjar A, Fox E. Efficacy and safety of entrectinib in children with extracranial solid or central nervous system (CNS) tumours harbouring NTRK or ROS1 fusions. Eur J Cancer. 2025 May 2;220:115308. doi: 10.1016/j.ejca.2025.115308. Epub 2025 Feb 22.
PubMed 40086048Desai AV, Robinson GW, Gauvain K, Basu EM, Macy ME, Maese L, Whipple NS, Sabnis AJ, Foster JH, Shusterman S, Yoon J, Weiss BD, Abdelbaki MS, Armstrong AE, Cash T, Pratilas CA, Corradini N, Marshall LV, Farid-Kapadia M, Chohan S, Devlin C, Meneses-Lorente G, Cardenas A, Hutchinson KE, Bergthold G, Caron H, Chow Maneval E, Gajjar A, Fox E. Entrectinib in children and young adults with solid or primary CNS tumors harboring NTRK, ROS1, or ALK aberrations (STARTRK-NG). Neuro Oncol. 2022 Oct 3;24(10):1776-1789. doi: 10.1093/neuonc/noac087.
PubMed 35395680Doebele RC, Drilon A, Paz-Ares L, Siena S, Shaw AT, Farago AF, Blakely CM, Seto T, Cho BC, Tosi D, Besse B, Chawla SP, Bazhenova L, Krauss JC, Chae YK, Barve M, Garrido-Laguna I, Liu SV, Conkling P, John T, Fakih M, Sigal D, Loong HH, Buchschacher GL Jr, Garrido P, Nieva J, Steuer C, Overbeck TR, Bowles DW, Fox E, Riehl T, Chow-Maneval E, Simmons B, Cui N, Johnson A, Eng S, Wilson TR, Demetri GD; trial investigators. Entrectinib in patients with advanced or metastatic NTRK fusion-positive solid tumours: integrated analysis of three phase 1-2 trials. Lancet Oncol. 2020 Feb;21(2):271-282. doi: 10.1016/S1470-2045(19)30691-6. Epub 2019 Dec 11.
PubMed 31838007