AzTrials
AzTrials

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.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

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
Are there results?
Not yet: the study is under way

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

Other trials in United States

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

Other trials in China

France2 sites

  • Centre Leon Berard

    Lyon, 69373

  • Hôpital de la Timone, Oncologie Pédiatrique

    Marseille, 13385

Other trials in France

United Kingdom2 sites

  • Royal Marsden Hospital (Sutton)

    London, SW3 6JJ

  • Royal Victoria Infirmary

    Newcastle upon Tyne, NE1 4LP

Other trials in United Kingdom

Canada1 site

  • The Hospital for Sick Children

    Toronto, Ontario, M5G 1X8

Other trials in Canada

Germany1 site

  • Universitaetsklinikum Heidelberg

    Heidelberg, Baden-Wurttemberg, 69120

Other trials in Germany

Hong Kong1 site

  • Hong Kong Children's Hospital

    Hong Kong, 00000

Other trials in Hong Kong

Italy1 site

  • Fondazione IRCCS Istituto Nazionale dei Tumori

    Milan, Lombardy, 20133

Other trials in Italy

Spain1 site

  • Hospital Infantil Universitario Nino Jesus

    Madrid, 28009

Other trials in Spain

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.

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 groups in NCT02650401
Study groupRoleWhat they receive
Extracranial solid tumors harboring NTRK1/2/3,Active comparatorArm 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, ALKActive comparatorArm closed for further enrollment molecular alterations, including gene fusions Oral entrectinib (RXDX-101)
Receives: Drug: Entrectinib
NeuroblastomaActive comparatorArm closed for further enrollment Oral entrectinib (RXDX-101)
Receives: Drug: Entrectinib
Non-neuroblastoma, extracranial solid tumorsActive comparatorArm closed for further enrollment harboring - NTRK1/2/3, ROS1, ALK gene fusions Oral entrectinib (RXDX-101)
Receives: Drug: Entrectinib
Any participant unable to swallow capsulesActive comparatorArm 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, ROS1Active comparatorgene fusions Oral entrectinib (RXDX-101)
Receives: Drug: Entrectinib
Expansion: Extracranial solid tumors harboring NTRK1/2/3, ROS1Active comparatorNTRK 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.

  1. Maximum Tolerated Dose (MTD)

    Assessed by National Cancer Institute Common Terminology for Adverse Events Criteria (NCI CTCAE v4.03)

    Measured: Approximately 6 months

  2. 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

  3. 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

  4. 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

  5. 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

  6. Cohort B: Objective Response Rate (ORR)

    Assessed by RANO per the BICR

    Measured: Approximately 6 months

  7. Cohort D: ORR

    Assessed by RECIST v1.1 per the BICR

    Measured: Approximately 6 months

Secondary outcomes (62)

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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

  13. 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

  14. 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

  15. 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

  16. 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

  17. 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

  18. 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

  19. 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

  20. 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

  21. 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

  22. Cohort A, D, or E: Clinical Benefit Rate (CBR)

    Assessed by RECIST v1.1 per the BICR and investigator

    Measured: Approximately 6 months

  23. Cohort B or E: CBR

    Assessed by RANO per the BICR and investigator

    Measured: Approximately 6 months

  24. Cohort C: CBR

    Assessed by the Curie scale per the BICR and investigator

    Measured: Approximately 6 months

  25. Cohort A, D, or E: Progression-free Survival (PFS)

    Assessed by RECIST v1.1 per the BICR and investigator

    Measured: Approximately 6 months

  26. Cohort B or E: PFS

    Assessed by RANO per the BICR and investigator

    Measured: Approximately 6 months

  27. Cohort C: PFS

    Assessed by the Curie scale per the BICR and investigator

    Measured: Approximately 6 months

  28. Cohort A, D, or E: Overall Survival (OS)

    Assessed by RECIST v1.1

    Measured: Approximately 6 months

  29. Cohort B or E: OS

    Assessed by RANO

    Measured: Approximately 6 months

  30. Cohort A, D, or E: ORR

    Assessed by RECIST v1.1 per the BICR and investigator

    Measured: Approximately 6 months

  31. Cohort B or E: ORR

    Assessed by RANO per the BICR and investigator

    Measured: Approximately 6 months

  32. Cohort C: ORR

    Assessed by the Curie scale per the BICR and investigator

    Measured: Approximately 6 months

  33. Cohort A, D, or E: Time to response (TTR)

    Assessed by RECIST v1.1 per the BICR and investigator

    Measured: Approximately 6 months

  34. Cohort B or E: TTR

    Assessed by RANO per the BICR and investigator

    Measured: Approximately 6 months

  35. Cohort C: TTR

    Assessed by the Curie scale per the BICR and investigator

    Measured: Approximately 6 months

  36. Cohort A, D, or E: Duration of Response (DOR)

    Assessed by RECIST v1.1 per the BICR and investigator

    Measured: Approximately 6 months

  37. Cohort B or E: DOR

    Assessed by RANO per the BICR and investigator

    Measured: Approximately 6 months

  38. Cohort C: DOR

    Assessed by the Curie scale per the BICR and investigator

    Measured: Approximately 6 months

  39. 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

  40. 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

  41. 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

  42. 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

  43. 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

  44. 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

  45. 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

  46. 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

  47. 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

  48. 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

  49. 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

  50. 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

  51. 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

  52. 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

  53. 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

  54. 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

  55. 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

  56. 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

  57. 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

  58. 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

  59. 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

  60. 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

  61. 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

  62. 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.

  1. First posted8 Jan 2016 (estimated)
  2. Study start3 May 2016
  3. Primary completion30 Jun 2027 (estimated)
  4. Study completion30 Jun 2027 (estimated)

Resources

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)
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 40086048

  • Desai 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 35395680

  • Doebele 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

Questions about this trial

What is this clinical trial studying?

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.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 21 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 23 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 26 sites in United States, China, France, United Kingdom, Canada and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximum Tolerated Dose (MTD) (time frame: Approximately 6 months). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02650401, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2026.

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