Evidence map›Paper›PMID 35395680›Full record

Trial reportNeuro-oncology2022

Entrectinib in children and young adults with solid or primary CNS tumors harboring NTRK, ROS1, or ALK aberrations (STARTRK-NG).

Ami V Desai, Giles W Robinson, Karen Gauvain, Ellen M Basu, Margaret E Macy, Luke Maese, Nicholas S Whipple, Amit J Sabnis, Jennifer H Foster, Suzanne Shusterman and 19 more

Registry-linked trialOpen access · bronzeAbstract readClinical Trial, Phase IClinical Trial, Phase II
In one paragraph

Trial report in Neuro-oncology, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02650401 (A Phase 1/2, Open-Label, Dose-Escalation And Expansion Study Of Entrectinib), which is not on this map. Cited by 78 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
78citing papers in PubMed, 2 pooled it
17.6field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02650401 phase1 / phase2active not recruitingnot on this map

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

TypeinterventionalSponsorHoffmann-La RocheRan2016 to 2026Enrolled69ConditionsSolid Tumors, CNS TumorsArmsEntrectinib
3 · Its place in the literature

Who cites it

78 citing papers in PubMed, 2 syntheses or guidelines pooled it, 128 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Article
  4. Article
  5. Advances in the management of pediatric low-grade glioma.Neurotherapeutics : the journal of the American Society for Experimental NeuroTherapeutics · 2026
    Review
  6. Post-recurrence management of malignant glial brain tumors: therapeutic strategies, evidence and limitations, palliative care, terminal sedation, and end-of-life considerations.Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2026
    Review
  7. Review
  8. TRK inhibitors in pediatric gliomas.Neuro-oncology advances · 2026
    Review
  9. Article
  10. Review
  11. Recent Advances in Targeted Therapies for Adult Gliomas.Current neurology and neuroscience reports · 2026
    Review
  12. Article
  13. Review
  14. Review
  15. Review
  16. Review
  17. Article
  18. Review
  19. Review
  20. Review

18 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

29 authors at 20 institutions in 5 countries.

Ami V DesaiDepartment of Pediatrics, Section of Hematology/Oncology/Stem Cell Transplantation, University of Chicago Medical Center, Chicago, Illinois, USA.ORCID 0000-0001-9658-3156
Giles W RobinsonDivision of Neuro-Oncology, Department of Oncology, St. Jude Children's Research Hospital, Memphis, Tennessee, USA.
Karen GauvainPediatric Neuro-Oncology, Washington University School of Medicine, St. Louis, Missouri, USA.
Ellen M BasuDepartment of Pediatrics, Memorial Sloan Kettering Cancer Center, New York, New York, USA.
Margaret E MacyPediatric Hematology-Oncology, Children's Hospital Colorado, University of Colorado Anschutz Medical Campus, Aurora, Colorado, USA.
Luke MaeseDepartment of Pediatrics, Division of Hematology/Oncology, University of Utah/Huntsman Cancer Institute, Salt Lake City, Utah, USA.
Nicholas S WhipplePediatric Hematology-Oncology, University of Utah, Salt Lake City, Utah, USA.
Amit J SabnisDivision of Pediatric Oncology, Department of Pediatrics, University of California, San Francisco, California, USA.
Jennifer H FosterDepartment of Pediatrics, Hematology-Oncology, Texas Children's Hospital, Houston, Texas, USA.
Suzanne ShustermanPediatric Hematology and Oncology, Dana Farber Cancer Institute/Children's Cancer and Blood Disorders Center, Boston, Massachusetts, USA.
Janet YoonDepartment of Pediatrics, University of California San Diego, San Diego, California, USA.
Brian D WeissDepartment of Pediatrics, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, USA.
Mohamed S AbdelbakiDivision of Hematology & Oncology, Nationwide Children's Hospital, Columbus, Ohio, USA.
Amy E ArmstrongDivision of Pediatric Hematology/Oncology, Washington University School of Medicine, St. Louis, Missouri, USA.
Thomas CashPediatric Hematology/Oncology, Aflac Cancer & Blood Disorders Center, Children's Healthcare of Atlanta, Emory University School of Medicine, Atlanta, Georgia, USA.
Christine A PratilasDepartment of Oncology, Division of Pediatric Oncology, Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.
Nadège CorradiniDepartment of Pediatric Hematology and Oncology, Institute of Pediatric Hematology and Oncology (IHOPe), Léon Bérard Cancer Centre, Lyon, France.
Lynley V MarshallChildren and Young People's Unit, The Royal Marsden Hospital and The Institute of Cancer Research, London, UK.
Mufiza Farid-KapadiaBiometrics Department, F. Hoffmann-La Roche Ltd., Mississauga, Ontario, Canada.
Saibah ChohanPDD Data & Statistical Sciences, F. Hoffmann-La Roche Ltd., Mississauga, Ontario, Canada.
Clare DevlinPharma Development Oncology and Hematology, Roche Products Ltd., Welwyn Garden City, UK.
Georgina Meneses-LorentePharma Research and Early Development, Roche Products Ltd., Welwyn Garden City, UK.
Alison CardenasClinical Safety, Genentech, Inc., South San Francisco, California, USA.
Katherine E HutchinsonOncology Biomarker Development, Genentech, Inc., South San Francisco, California, USA.
Guillaume BergtholdProduct Development Oncology, F. Hoffmann-La Roche Ltd, Basel, Switzerland.
Hubert CaronProduct Development Oncology, F. Hoffmann-La Roche Ltd, Basel, Switzerland.
Edna Chow ManevalClinical Development, Ignyta, Inc., San Diego, California, USA.
Amar GajjarDivision of Neuro-Oncology, Department of Oncology, St. Jude Children's Research Hospital, Memphis, Tennessee, USA.
Elizabeth FoxDepartment of Oncology, St. Jude Children's Research Hospital, Memphis, Tennessee, USA.
St. Jude Children's Research Hospital · USRoche (Canada) · CARoche (Switzerland) · CHRoche (United Kingdom) · GBUniversity of Utah · USWashington University in St. Louis · USChildren's Hospital Colorado · USCincinnati Children's Hospital Medical Center · USDana-Farber Cancer Institute · USEmory University · USIgnyta (United States) · USInstitut d’Hématologie et d’Oncologie Pédiatrique · FRInstitute of Cancer Research · GBJohns Hopkins University · USMemorial Sloan Kettering Cancer Center · USNationwide Children's Hospital · USTexas Children's Hospital · USUniversity of California San Diego · USUniversity of California, San Francisco · USUniversity of Chicago Medical Center · US

Funding

X-RAY CRYSTALLOGRAPHYP30CA008748 · NCI · SLOAN-KETTERING INSTITUTE FOR CANCER RES · PI Hongbiao Carl Lekaye · 1985 to 2026
$347.4M
Defining and targeting ER quality control dependence in rhabdomyosarcomaK08CA218691 · NCI · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI SABNIS, AMIT J. · 2018 to 2022
$1.1M
NCI NIH HHS K08 CA218691NCI NIH HHS P30 CA008748
6 · The paper itself

Abstract

backgroundEntrectinib is a TRKA/B/C, ROS1, ALK tyrosine kinase inhibitor approved for the treatment of adults and children aged ≥12 years with NTRK fusion-positive solid tumors and adults with ROS1 fusion-positive non-small-cell lung cancer. We report an analysis of the STARTRK-NG trial, investigating the recommended phase 2 dose (RP2D) and activity of entrectinib in pediatric patients with solid tumors including primary central nervous system tumors.

methodsSTARTRK-NG (NCT02650401) is a phase 1/2 trial. Phase 1, dose-escalation of oral, once-daily entrectinib, enrolled patients aged <22 years with solid tumors with/without target NTRK1/2/3, ROS1, or ALK fusions. Phase 2, basket trial at the RP2D, enrolled patients with intracranial or extracranial solid tumors harboring target fusions or neuroblastoma. Primary endpoints: phase 1, RP2D based on toxicity; phase 2, objective response rate (ORR) in patients harboring target fusions. Safety-evaluable patients: ≥1 dose of entrectinib; response-evaluable patients: measurable/evaluable baseline disease and ≥1 dose at RP2D.

resultsAt data cutoff, 43 patients, median age of 7 years, were response-evaluable. In phase 1, 4 patients experienced dose-limiting toxicities. The most common treatment-related adverse event was weight gain (48.8%). Nine patients experienced bone fractures (20.9%). In patients with fusion-positive tumors, ORR was 57.7% (95% CI 36.9-76.7), median duration of response was not reached, and median (interquartile range) duration of treatment was 10.6 months (4.2-18.4).

conclusionsEntrectinib resulted in rapid and durable responses in pediatric patients with solid tumors harboring NTRK1/2/3 or ROS1 fusions.

Indexed as

Carcinoma, Non-Small-Cell LungLung NeoplasmsBenzamidesChildHumansIndazolesProtein Kinase InhibitorsProtein-Tyrosine KinasesProto-Oncogene ProteinsReceptor Protein-Tyrosine KinasesYoung AdultBenzamidesentrectinibIndazolesProtein Kinase InhibitorsProtein-Tyrosine KinasesProto-Oncogene ProteinsReceptor Protein-Tyrosine KinasesROS1 protein, humanCNS tumorsentrectinibpediatricrecommended phase 2 dosesolid tumors

Identifiers

PMID35395680
PMCPMC9527518
OpenAlexW4223537410

What OpenQuestion holds

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LicenceCC BY-NC
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.