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STARTRK-NG: 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

Sponsor
Hoffmann-La Roche (Industry)
Overall Status
Recruiting
CT.gov ID
NCT02650401
Collaborator
(none)
68
Enrollment
39
Locations
7
Arms
135.9
Anticipated Duration (Months)
1.7
Patients Per Site
0
Patients Per Site Per Month

Study Details

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
Phase 1/Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
68 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
Anticipated Primary Completion Date :
Aug 30, 2027
Anticipated Study Completion Date :
Aug 30, 2027

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 Names:
  • 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 Names:
  • RXDX-101

    		•
    Active Comparator: Neuroblastoma

    Arm closed for further enrollment Oral entrectinib (RXDX-101)

    Drug: Entrectinib
    TRKA/B/C, ROS1, and ALK inhibitor
    Other Names:
  • 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 Names:
  • 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 Names:
  • 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 Names:
  • 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 Names:
  • RXDX-101

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Maximum Tolerated Dose (MTD) [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 [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 [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) [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 [Approximately 6 months]

      Assessed by NCI CTCAE v4.03

    6. Cohort B: Objective Response Rate (ORR) [Approximately 6 months]

      Assessed by RANO per the BICR

    7. Cohort D: ORR [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 [Approximately 24 months]

      AE, ECG and Labs assessed by NCI CTCAE v4.03

    2. Maximum observed plasma drug concentration (Cmax) using F1 Formulation [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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) [Approximately 6 months]

      Assessed by RECIST v1.1 per the BICR and investigator

    23. Cohort B or E: CBR [Approximately 6 months]

      Assessed by RANO per the BICR and investigator

    24. Cohort C: CBR [Approximately 6 months]

      Assessed by the Curie scale per the BICR and investigator

    25. Cohort A, D, or E: Progression-free Survival (PFS) [Approximately 6 months]

      Assessed by RECIST v1.1 per the BICR and investigator

    26. Cohort B or E: PFS [Approximately 6 months]

      Assessed by RANO per the BICR and investigator

    27. Cohort C: PFS [Approximately 6 months]

      Assessed by the Curie scale per the BICR and investigator

    28. Cohort A, D, or E: Overall Survival (OS) [Approximately 6 months]

      Assessed by RECIST v1.1

    29. Cohort B or E: OS [Approximately 6 months]

      Assessed by RANO

    30. Cohort A, D, or E: ORR [Approximately 6 months]

      Assessed by RECIST v1.1 per the BICR and investigator

    31. Cohort B or E: ORR [Approximately 6 months]

      Assessed by RANO per the BICR and investigator

    32. Cohort C: ORR [Approximately 6 months]

      Assessed by the Curie scale per the BICR and investigator

    33. Cohort A, D, or E: Time to response (TTR) [Approximately 6 months]

      Assessed by RECIST v1.1 per the BICR and investigator

    34. Cohort B or E: TTR [Approximately 6 months]

      Assessed by RANO per the BICR and investigator

    35. Cohort C: TTR [Approximately 6 months]

      Assessed by the Curie scale per the BICR and investigator

    36. Cohort A, D, or E: Duration of Response (DOR) [Approximately 6 months]

      Assessed by RECIST v1.1 per the BICR and investigator

    37. Cohort B or E: DOR [Approximately 6 months]

      Assessed by RANO per the BICR and investigator

    38. Cohort C: DOR [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [Approximately 6 months]

      Assessed by RANO per the BICR and investigator

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    0 Years to 18 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    1. 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

    1. Histologic/molecular diagnosis of malignancy at diagnosis or the time of relapse

    2. Archival tumor tissue from diagnosis or, preferably, at relapse

    3. Performance status: Lansky or Karnofsky score ≥ 60% and minimum life expectancy of at least 4 weeks

    4. 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

    5. Participants must have recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to enrollment

    6. Adequate organ and neurologic function

    7. 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.

    8. 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

    Site City State Country Postal Code
    1 Children'S Hospital of Orange County Orange California United States 92868-3874
    2 Rady Childrens Hospital San Diego California United States 92123
    3 UCSF Benioff Children's Hospital; UCSF Pediatrics Hematology Oncology San Francisco California United States 94158
    4 Children's Hospital Colorado; Center For Cancer/Blood Disorder Aurora Colorado United States 80045
    5 Children's National Medical Center; Department of Pediatrics Washington District of Columbia United States 20037
    6 Egleston Children's Hospital at Emory University Atlanta; Pediatric Hematology/Oncology Atlanta Georgia United States 30322
    7 University of Chicago; Comer Children's Hospital/Department of Pediatrics Chicago Illinois United States 60637
    8 Johns Hopkins University Baltimore Maryland United States 21205
    9 Dana Farber Cancer Institute Boston Massachusetts United States 02215
    10 University of Minnesota Childrens' Hospital Minneapolis Minnesota United States 55455
    11 Washington University,St. Louis Children's Hospital; Neurology, Movement Disorder Saint Louis Missouri United States 63110
    12 Morgan Stanley Children's Hospital; Herbert Irving Cancer Center New York New York United States 10032
    13 Memorial Sloan Kettering Cancer Center; Pediatrics New York New York United States 10065
    14 Cincinnati Children's Hospital Medical Center Cincinnati Ohio United States 45229
    15 Nationwide Children's Hospital; Dept. of Pulmonology Columbus Ohio United States 43205
    16 Oregon Health & Science Uni Portland Oregon United States 97239
    17 Children's Hospital of Philadelphia Philadelphia Pennsylvania United States 19104
    18 St. Jude Children'S Research Hospital Memphis Tennessee United States 38105
    19 Cook Childrens Medical Center Fort Worth Texas United States 76104
    20 Texas Children's Cancer and Hematology Center Houston Texas United States 77030
    21 Primary Children's Hospital Salt Lake City Utah United States 84113
    22 The Hospital for Sick Children Toronto Ontario Canada M5G 1X8
    23 Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine Shanghai China 200092
    24 Centre Leon Berard; Pediatrie Lyon France 69373
    25 Hôpital de la Timone, Oncologie Pédiatrique Marseille France 13385
    26 Hopital Purpan; Pediatrie - Hematologie - Oncologie pediatrique Toulouse France 31500
    27 Institut Gustave Roussy; Service de Pathologie Morphologique Villejuif France 94805
    28 Universitaetsklinikum Heidelberg Heidelberg Germany 69120
    29 Hong Kong Children's Hospital Hong Kong Hong Kong
    30 Fondazione IRCCS Istituto Nazionale dei Tumori; Struttura Complessa di Pediatria Oncologica Milano Lombardia Italy 20133
    31 A. O. Città della Salute e della Scienza di Torino; SC Oncoematologia e Centro Trapianti AOOIRM Torino Piemonte Italy 10126
    32 Seoul National University Hospital Seoul Korea, Republic of 03080
    33 Hospital Sant Joan de Deu; Servicio de Oncologia y Hematologia Esplugues de Llobregat Barcelona Spain 08950
    34 Hospital Infantil Universitario Nino Jesus Madrid Spain 28009
    35 National Taiwan University Hospital; Department of Paediatrics Taipei Taiwan 100
    36 Chang Gung Memorial Hospital, Linkou; Department of Pediatric Internal Medicine Taoyuan City Taiwan 333
    37 Leeds General Infirmary Leeds United Kingdom LS1 3EX
    38 Royal Victoria Infirmary; Pharmacy Newcastle upon Tyne United Kingdom NE1 4LP
    39 Royal Marsden NHS Foundation Trust Sutton United Kingdom SM2 5PT

    Sponsors and Collaborators

    • Hoffmann-La Roche

    Investigators

    • Study Director: Clinical Trials, Hoffmann-La Roche

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Hoffmann-La Roche
    ClinicalTrials.gov Identifier:
    NCT02650401
    Other Study ID Numbers:
    • RXDX-101-03
    • CO40778
    First Posted:
    Jan 8, 2016
    Last Update Posted:
    Aug 25, 2022
    Last Verified:
    Aug 1, 2022
    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
    Entrectinib

    Study Results

    No Results Posted as of Aug 25, 2022