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)

• ClinicalTrials.gov Identifier: NCT02650401
• Recruitment Status: Active, not recruiting
• First Posted: January 8, 2016
• Last Update Posted: March 29, 2024
• Sponsor: Hoffmann-La Roche
• Information provided by (Responsible Party): Hoffmann-La Roche

Study Description

Brief 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 NTRK1/2/3 or ROS1 gene fusions.

Condition or disease	Intervention/treatment	Phase
Solid Tumors; CNS Tumors	Drug: Entrectinib	Phase 1; Phase 2

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 69 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: May 3, 2016
• Estimated Primary Completion Date: June 15, 2025
• Estimated Study Completion Date: June 15, 2025

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Extracranial solid tumors harboring NTRK1/2/3,; Arm closed for further enrollment ROS1, ALK non-gene fusion molecular alterations Oral entrectinib (RXDX-101)	Drug: Entrectinib; TRKA/B/C, ROS1, and ALK inhibitor; Other Name: RXDX-101
Active Comparator: CNS tumors harboring- NTRK1/2/3, ROS1, ALK; Arm closed for further enrollment molecular alterations, including gene fusions Oral entrectinib (RXDX-101)	Drug: Entrectinib; TRKA/B/C, ROS1, and ALK inhibitor; Other Name: RXDX-101
Active Comparator: Neuroblastoma; Arm closed for further enrollment Oral entrectinib (RXDX-101)	Drug: Entrectinib; TRKA/B/C, ROS1, and ALK inhibitor; Other Name: RXDX-101
Active Comparator: Non-neuroblastoma, extracranial solid tumors; Arm closed for further enrollment harboring - NTRK1/2/3, ROS1, ALK gene fusions Oral entrectinib (RXDX-101)	Drug: Entrectinib; TRKA/B/C, ROS1, and ALK inhibitor; Other Name: RXDX-101
Active Comparator: Any participant unable to swallow capsules; Arm closed for further enrollment Any participant who otherwise meet all other eligibility criteria Oral entrectinib (RXDX-101)	Drug: Entrectinib; TRKA/B/C, ROS1, and ALK inhibitor; Other Name: RXDX-101
Active Comparator: Expansion: CNS tumors harboring NTRK1/2/3, ROS1; gene fusions Oral entrectinib (RXDX-101)	Drug: Entrectinib; TRKA/B/C, ROS1, and ALK inhibitor; Other Name: RXDX-101
Active Comparator: Expansion: Extracranial solid tumors harboring NTRK1/2/3, ROS1; NTRK 1,2,3 and ROS1 fusions Oral entrectinib (RXDX-101)	Drug: Entrectinib; TRKA/B/C, ROS1, and ALK inhibitor; Other Name: RXDX-101

Outcome Measures

Primary Outcome Measures :

1. Maximum Tolerated Dose (MTD) [ Time Frame: Approximately 6 months ]
   Assessed by National Cancer Institute Common Terminology for Adverse Events Criteria (NCI CTCAE v4.03)
2. Recommended Phase 2 Dose (RP2D) of F1 Formulation In Pediatric Participants Able To Swallow Intact Capsules [ Time Frame: Approximately 6 months ]
   Assessed by NCI CTCAE v4.03
3. Recommended Phase 2 Dose (RP2D) of F06 Formulation In Pediatric Participants Able To Swallow Intact Capsules [ Time Frame: Approximately 6 months ]
   Assessed by NCI CTCAE v4.03
4. Recommended Phase 2 Dose (RP2D) of F06 Formulation In Pediatric In Participants Dosed Via Feeding Tube (Nasogastric Tube Or Gastric Tube) [ Time Frame: Approximately 6 months ]
   Assessed by NCI CTCAE v4.03
5. Recommended Phase 2 Dose (RP2D) Of Minitablets/F15 Formulation In Pediatric Participants Unable To Swallow Intact Capsules [ Time Frame: Approximately 6 months ]
   Assessed by NCI CTCAE v4.03
6. Cohort B: Objective Response Rate (ORR) [ Time Frame: Approximately 6 months ]
   Assessed by RANO per the BICR
7. Cohort D: ORR [ Time Frame: Approximately 6 months ]
   Assessed by RECIST v1.1 per the BICR

Secondary Outcome Measures :

1. Safety and Tolerability - AE, ECG and Labs assessed by NCI CTCAE v4.03 [ Time Frame: Approximately 24 months ]
   AE, ECG and Labs assessed by NCI CTCAE v4.03
2. Maximum observed plasma drug concentration (Cmax) using F1 Formulation [ Time Frame: Approximately 24 months ]
   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
3. Maximum observed plasma drug concentration (Cmax) using F06 Formulation given intact [ Time Frame: Approximately 24 months ]
   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
4. Maximum observed plasma drug concentration (Cmax) using F06 Formulation administered via feeding tube [ Time Frame: Approximately 24 months ]
   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
5. Maximum observed plasma drug concentration (Cmax) using minitablets/F15 [ Time Frame: Approximately 24 months ]
   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
6. Time to Cmax, by inspection (Tmax) using F1 Formulation [ Time Frame: Approximately 24 months ]
   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
7. Time to Cmax, by inspection (Tmax) using F06 Formulation given intact [ Time Frame: Approximately 24 months ]
   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
8. Time to Cmax, by inspection (Tmax) using F06 Formulation administered via feeding tube [ Time Frame: Approximately 24 months ]
   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
9. Time to Cmax, by inspection (Tmax) using minitablets/F15 [ Time Frame: Approximately 24 months ]
   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
10. AUC at steady state (AUCss) using F1 Formulation [ Time Frame: Approximately 24 months ]
    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
11. AUC at steady state (AUCss) using F06 Formulation given intact [ Time Frame: Approximately 24 months ]
    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
12. AUC at steady state (AUCss) using F06 Formulation administered via feeding tube [ Time Frame: Approximately 24 months ]
    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
13. AUC at steady state (AUCss) using minitablets/F15 [ Time Frame: Approximately 24 months ]
    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
14. Terminal half life (t½) using F1 Formulation [ Time Frame: Approximately 24 months ]
    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
15. Terminal half life (t½) using F06 Formulation given intact [ Time Frame: Approximately 24 months ]
    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
16. Terminal half life (t½) using F06 Formulation administered via feeding tube [ Time Frame: Approximately 24 months ]
    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
17. Terminal half life (t½) using minitablets/F15 [ Time Frame: Approximately 24 months ]
    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
18. Area under the drug concentration by time curve (AUC) using F1 Formulation [ Time Frame: Approximately 24 months ]
    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
19. Area under the drug concentration by time curve (AUC) using F06 Formulation given intact [ Time Frame: Approximately 24 months ]
    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
20. Area under the drug concentration by time curve (AUC) using F06 Formulation administered via feeding tube [ Time Frame: Approximately 24 months ]
    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
21. Area under the drug concentration by time curve (AUC) using minitablets/F15 [ Time Frame: Approximately 24 months ]
    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
22. Cohort A, D, or E: Clinical Benefit Rate (CBR) [ Time Frame: Approximately 6 months ]
    Assessed by RECIST v1.1 per the BICR and investigator
23. Cohort B or E: CBR [ Time Frame: Approximately 6 months ]
    Assessed by RANO per the BICR and investigator
24. Cohort C: CBR [ Time Frame: Approximately 6 months ]
    Assessed by the Curie scale per the BICR and investigator
25. Cohort A, D, or E: Progression-free Survival (PFS) [ Time Frame: Approximately 6 months ]
    Assessed by RECIST v1.1 per the BICR and investigator
26. Cohort B or E: PFS [ Time Frame: Approximately 6 months ]
    Assessed by RANO per the BICR and investigator
27. Cohort C: PFS [ Time Frame: Approximately 6 months ]
    Assessed by the Curie scale per the BICR and investigator
28. Cohort A, D, or E: Overall Survival (OS) [ Time Frame: Approximately 6 months ]
    Assessed by RECIST v1.1
29. Cohort B or E: OS [ Time Frame: Approximately 6 months ]
    Assessed by RANO
30. Cohort A, D, or E: ORR [ Time Frame: Approximately 6 months ]
    Assessed by RECIST v1.1 per the BICR and investigator
31. Cohort B or E: ORR [ Time Frame: Approximately 6 months ]
    Assessed by RANO per the BICR and investigator
32. Cohort C: ORR [ Time Frame: Approximately 6 months ]
    Assessed by the Curie scale per the BICR and investigator
33. Cohort A, D, or E: Time to response (TTR) [ Time Frame: Approximately 6 months ]
    Assessed by RECIST v1.1 per the BICR and investigator
34. Cohort B or E: TTR [ Time Frame: Approximately 6 months ]
    Assessed by RANO per the BICR and investigator
35. Cohort C: TTR [ Time Frame: Approximately 6 months ]
    Assessed by the Curie scale per the BICR and investigator
36. Cohort A, D, or E: Duration of Response (DOR) [ Time Frame: Approximately 6 months ]
    Assessed by RECIST v1.1 per the BICR and investigator
37. Cohort B or E: DOR [ Time Frame: Approximately 6 months ]
    Assessed by RANO per the BICR and investigator
38. Cohort C: DOR [ Time Frame: Approximately 6 months ]
    Assessed by the Curie scale per the BICR and investigator
39. Phase 2 Participants with NTRK1/2/3 or ROS1 gene fusions (Cohort B or E): ORR [ Time Frame: Approximately 6 months ]
    Assessed by RANO per the investigator
40. Phase 2 Participants with NTRK1/2/3 or ROS1 gene fusions (Cohort D or E): ORR [ Time Frame: Approximately 6 months ]
    Assessed by RECIST v1.1 per the investigator
41. Phase 1/2 Participants with NTRK1/2/3 gene fusions (Cohort A, D, or E): ORR [ Time Frame: Approximately 6 months ]
    Assessed by RECIST v1.1 per the BICR and investigator
42. Phase 1/2 Participants with NTRK1/2/3 gene fusions (Cohort B or E): ORR [ Time Frame: Approximately 6 months ]
    Assessed by RANO per the BICR and investigator
43. Phase 1/2 Participants with ROS1 gene fusions (Cohort A, D, or E): ORR [ Time Frame: Approximately 6 months ]
    Assessed by RECIST v1.1 per the BICR and investigator
44. Phase 1/2 Participants with ROS1 gene fusions (Cohort B or E): ORR [ Time Frame: Approximately 6 months ]
    Assessed by RANO per the BICR and investigator
45. Phase 1/2 Participants with NTRK1/2/3 or ROS1 gene fusions (Cohort A, D, or E): ORR [ Time Frame: Approximately 6 months ]
    Assessed by RECIST v1.1 per the BICR and investigator
46. Phase 1/2 Participants with NTRK1/2/3 or ROS1 gene fusions (Cohort B or E): ORR [ Time Frame: Approximately 6 months ]
    Assessed by RANO per the BICR and investigator
47. Phase 2 Participants with NTRK1/2/3 or ROS1 gene fusions (Cohort B or E): DOR [ Time Frame: Approximately 6 months ]
    Assessed by RANO per the BICR and investigator
48. Phase 2 Participants with NTRK1/2/3 or ROS1 gene fusions (Cohort D or E): DOR [ Time Frame: Approximately 6 months ]
    Assessed by RECIST v1.1 per the BICR and investigator
49. Phase 1/2 Participants with NTRK1/2/3 gene fusions (Cohort A, D, or E): DOR [ Time Frame: Approximately 6 months ]
    Assessed by RECIST v1.1 per the BICR and investigator
50. Phase 1/2 Participants with NTRK1/2/3 gene fusions (Cohort B or E): DOR [ Time Frame: Approximately 6 months ]
    Assessed by RANO per the BICR and investigator
51. Phase 1/2 Participants with ROS1 gene fusions (Cohort A, D, or E): DOR [ Time Frame: Approximately 6 months ]
    Assessed by RECIST v1.1 per the BICR and investigator
52. Phase 1/2 Participants with ROS1 gene fusions (Cohort B or E): DOR [ Time Frame: Approximately 6 months ]
    Assessed by RANO per the BICR and investigator
53. Phase 1/2 Participants with NTRK1/2/3 or ROS1 gene fusions (Cohort A, D, or E): DOR [ Time Frame: Approximately 6 months ]
    Assessed by RECIST v1.1 per the BICR and investigator
54. Phase 1/2 Participants with NTRK1/2/3 or ROS1 gene fusions (Cohort B or E): DOR [ Time Frame: Approximately 6 months ]
    Assessed by RANO per the BICR and investigator
55. Phase 2 Participants with NTRK1/2/3 or ROS1 gene fusions (Cohort B or E): TTR [ Time Frame: Approximately 6 months ]
    Assessed by RANO per the BICR and investigator
56. Phase 2 Participants with NTRK1/2/3 or ROS1 gene fusions (Cohort D or E): TTR [ Time Frame: Approximately 6 months ]
    Assessed by RECIST v1.1 per the BICR and investigator
57. Phase 1/2 Participants with NTRK1/2/3 gene fusions (Cohort A, D, or E): TTR [ Time Frame: Approximately 6 months ]
    Assessed by RECIST v1.1 per the BICR and investigator
58. Phase 1/2 Participants with NTRK1/2/3 gene fusions (Cohort B or E): TTR [ Time Frame: Approximately 6 months ]
    Assessed by RANO per the BICR and investigator
59. Phase 1/2 Participants with ROS1 gene fusions (Cohort A, D, or E): TTR [ Time Frame: Approximately 6 months ]
    Assessed by RECIST v1.1 per the BICR and investigator
60. Phase 1/2 Participants with ROS1 gene fusions (Cohort B or E): TTR [ Time Frame: Approximately 6 months ]
    Assessed by RANO per the BICR and investigator
61. Phase 1/2 Participants with NTRK1/2/3 or ROS1 gene fusions (Cohort A, D, or E): TTR [ Time Frame: Approximately 6 months ]
    Assessed by RECIST v1.1 per the BICR and investigator
62. Phase 1/2 Participants with NTRK1/2/3 or ROS1 gene fusions (Cohort B or E): TTR [ Time Frame: Approximately 6 months ]
    Assessed by RANO per the BICR and investigator

Eligibility Criteria

• Ages Eligible for Study: 0 Years to 18 Years (Child, Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

1. 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
     • Part E (closed): Participants must have measurable or evaluable disease, as defined by RECIST v1.1 ± Curie Scale or RANO

2. 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
3. Histologic/molecular diagnosis of malignancy at diagnosis or the time of relapse
4. Archival tumor tissue from diagnosis or, preferably, at relapse
5. Performance status: Lansky or Karnofsky score ≥ 60% and minimum life expectancy of at least 4 weeks
6. 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
7. Participants must have recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to enrollment
8. Adequate organ and neurologic function
9. 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.
10. 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

Exclusion Criteria:

1. Receiving other experimental therapy
2. Known congenital long QT syndrome
3. History of recent (3 months) symptomatic congestive heart failure or ejection fraction ≤50% at screening
4. Known active infections
5. Familial or personal history of congenital bone disorders, bone metabolism alterations or osteopenia
6. Receiving Enzyme Inducing Antiepileptic Drugs (EIAEDs) within 14 days of first dose.
7. Prior treatment with approved or investigational TRK or ROS1 inhibitors
8. Known hypersensitivity to entrectinib or any of the other excipients of the investigational medicinal product
9. Patients with NB with bone marrow space-only disease
10. Incomplete recovery from acute effects of any surgery prior to treatment.
11. Active gastrointestinal disease or other malabsorption syndromes that would impact drug absorption.
12. 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.

Contacts and Locations

Locations

United States, California

Children'S Hospital of Orange County

Orange, California, United States, 92868-3874

Rady Childrens Hospital

San Diego, California, United States, 92123

UCSF Benioff Children's Hospital; UCSF Pediatrics Hematology Oncology

San Francisco, California, United States, 94158

United States, Colorado

Children's Hospital Colorado; Center For Cancer/Blood Disorder

Aurora, Colorado, United States, 80045

United States, District of Columbia

Children's National Medical Center; Department of Pediatrics

Washington, District of Columbia, United States, 20037

United States, Georgia

Egleston Children's Hospital at Emory University Atlanta; Pediatric Hematology/Oncology

Atlanta, Georgia, United States, 30322

United States, Illinois

University of Chicago; Comer Children's Hospital/Department of Pediatrics

Chicago, Illinois, United States, 60637

United States, Maryland

Johns Hopkins University

Baltimore, Maryland, United States, 21205

United States, Massachusetts

Dana Farber Cancer Institute

Boston, Massachusetts, United States, 02215

United States, Minnesota

University of Minnesota Childrens' Hospital

Minneapolis, Minnesota, United States, 55455

United States, Missouri

Washington University,St. Louis Children's Hospital; Neurology, Movement Disorder

Saint Louis, Missouri, United States, 63110

United States, New York

Morgan Stanley Children's Hospital; Herbert Irving Cancer Center

New York, New York, United States, 10032

Memorial Sloan Kettering Cancer Center; Pediatrics

New York, New York, United States, 10065

United States, Ohio

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States, 45229

Nationwide Children's Hospital; Dept. of Pulmonology

Columbus, Ohio, United States, 43205

United States, Oregon

Oregon Health & Science Uni

Portland, Oregon, United States, 97239

United States, Pennsylvania

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States, 19104

United States, Tennessee

St. Jude Children'S Research Hospital

Memphis, Tennessee, United States, 38105

United States, Texas

Cook Childrens Medical Center

Fort Worth, Texas, United States, 76104

Texas Children's Cancer and Hematology Center

Houston, Texas, United States, 77030

United States, Utah

Primary Children's Hospital

Salt Lake City, Utah, United States, 84113

Canada, Ontario

The Hospital for Sick Children

Toronto, Ontario, Canada, M5G 1X8

China

Beijing Children's Hospital, Capital Medical University; Oncological Surgery Department

Beijing City, China, 100032

Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Shanghai, China, 200092

France

Centre Leon Berard; Pediatrie

Lyon, France, 69373

Hôpital de la Timone, Oncologie Pédiatrique

Marseille, France, 13385

Hopital Purpan; Pediatrie - Hematologie - Oncologie pediatrique

Toulouse, France, 31500

Institut Gustave Roussy; Service de Pathologie Morphologique

Villejuif, France, 94805

Germany

Universitaetsklinikum Heidelberg

Heidelberg, Germany, 69120

Hong Kong

Hong Kong Children's Hospital

Hong Kong, Hong Kong

Italy

Fondazione IRCCS Istituto Nazionale dei Tumori; Struttura Complessa di Pediatria Oncologica

Milano, Lombardia, Italy, 20133

A. O. Città della Salute e della Scienza di Torino; SC Oncoematologia e Centro Trapianti AOOIRM

Torino, Piemonte, Italy, 10126

Korea, Republic of

Seoul National University Hospital

Seoul, Korea, Republic of, 03080

Spain

Hospital Sant Joan de Deu; Servicio de Oncologia y Hematologia

Esplugues de Llobregat, Barcelona, Spain, 08950

Hospital Infantil Universitario Nino Jesus

Madrid, Spain, 28009

Taiwan

National Taiwan University Hospital; Department of Paediatrics

Taipei, Taiwan, 100

Chang Gung Memorial Hospital, Linkou; Department of Pediatric Internal Medicine

Taoyuan City, Taiwan, 333

United Kingdom

Leeds General Infirmary

Leeds, United Kingdom, LS1 3EX

Royal Victoria Infirmary; Pharmacy

Newcastle upon Tyne, United Kingdom, NE1 4LP

Royal Marsden NHS Foundation Trust

Sutton, United Kingdom, SM2 5PT

Sponsors and Collaborators

Hoffmann-La Roche

Investigators

• Study Director: Clinical Trials; Hoffmann-La Roche

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

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. Erratum In: Lancet Oncol. 2020 Feb;21(2):e70. Lancet Oncol. 2020 Jul;21(7):e341. Lancet Oncol. 2020 Aug;21(8):e372. Lancet Oncol. 2021 Oct;22(10):e428.

• Responsible Party: Hoffmann-La Roche
• ClinicalTrials.gov Identifier: NCT02650401
• Other Study ID Numbers: RXDX-101-03; CO40778 ( Other Identifier: Hoffmann-La Roche )
• First Posted: January 8, 2016
• Last Update Posted: March 29, 2024
• Last Verified: March 2024

Keywords provided by Hoffmann-La Roche:

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; CNS tumors; Sarcoma; Ewing sarcoma; Glial tumors; Salivary Gland Cancer (MASC); Papillary thyroid cancer; Medulloblastoma; Wilms tumor (anaplastic)

Additional relevant MeSH terms:

Neoplasms; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Nervous System Diseases; Entrectinib; Protein Kinase Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action