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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)

Primary Purpose

Solid Tumors, CNS Tumors

Status
Active
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
Entrectinib
Sponsored by
Hoffmann-La Roche
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Solid Tumors focused on measuring 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)

Eligibility Criteria

0 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Children'S Hospital of Orange County
  • Rady Childrens Hospital
  • UCSF Benioff Children's Hospital; UCSF Pediatrics Hematology Oncology
  • Children's Hospital Colorado; Center For Cancer/Blood Disorder
  • Children's National Medical Center; Department of Pediatrics
  • Egleston Children's Hospital at Emory University Atlanta; Pediatric Hematology/Oncology
  • University of Chicago; Comer Children's Hospital/Department of Pediatrics
  • Johns Hopkins University
  • Dana Farber Cancer Institute
  • University of Minnesota Childrens' Hospital
  • Washington University,St. Louis Children's Hospital; Neurology, Movement Disorder
  • Morgan Stanley Children's Hospital; Herbert Irving Cancer Center
  • Memorial Sloan Kettering Cancer Center; Pediatrics
  • Cincinnati Children's Hospital Medical Center
  • Nationwide Children's Hospital; Dept. of Pulmonology
  • Oregon Health & Science Uni
  • Children's Hospital of Philadelphia
  • St. Jude Children'S Research Hospital
  • Cook Childrens Medical Center
  • Texas Children's Cancer and Hematology Center
  • Primary Children's Hospital
  • The Hospital for Sick Children
  • Beijing Children's Hospital, Capital Medical University; Oncological Surgery Department
  • Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
  • Centre Leon Berard; Pediatrie
  • Hôpital de la Timone, Oncologie Pédiatrique
  • Hopital Purpan; Pediatrie - Hematologie - Oncologie pediatrique
  • Institut Gustave Roussy; Service de Pathologie Morphologique
  • Universitaetsklinikum Heidelberg
  • Hong Kong Children's Hospital
  • Fondazione IRCCS Istituto Nazionale dei Tumori; Struttura Complessa di Pediatria Oncologica
  • A. O. Città della Salute e della Scienza di Torino; SC Oncoematologia e Centro Trapianti AOOIRM
  • Seoul National University Hospital
  • Hospital Sant Joan de Deu; Servicio de Oncologia y Hematologia
  • Hospital Infantil Universitario Nino Jesus
  • National Taiwan University Hospital; Department of Paediatrics
  • Chang Gung Memorial Hospital, Linkou; Department of Pediatric Internal Medicine
  • Leeds General Infirmary
  • Royal Victoria Infirmary; Pharmacy
  • Royal Marsden NHS Foundation Trust

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

Extracranial solid tumors harboring NTRK1/2/3,

CNS tumors harboring- NTRK1/2/3, ROS1, ALK

Neuroblastoma

Non-neuroblastoma, extracranial solid tumors

Any participant unable to swallow capsules

Expansion: CNS tumors harboring NTRK1/2/3, ROS1

Expansion: Extracranial solid tumors harboring NTRK1/2/3, ROS1

Arm Description

Arm closed for further enrollment ROS1, ALK non-gene fusion molecular alterations Oral entrectinib (RXDX-101)

Arm closed for further enrollment molecular alterations, including gene fusions Oral entrectinib (RXDX-101)

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

Arm closed for further enrollment harboring - NTRK1/2/3, ROS1, ALK gene fusions Oral entrectinib (RXDX-101)

Arm closed for further enrollment Any participant who otherwise meet all other eligibility criteria Oral entrectinib (RXDX-101)

gene fusions Oral entrectinib (RXDX-101)

NTRK 1,2,3 and ROS1 fusions Oral entrectinib (RXDX-101)

Outcomes

Primary Outcome Measures

Maximum Tolerated Dose (MTD)
Assessed by National Cancer Institute Common Terminology for Adverse Events Criteria (NCI CTCAE v4.03)
Recommended Phase 2 Dose (RP2D) of F1 Formulation In Pediatric Participants Able To Swallow Intact Capsules
Assessed by NCI CTCAE v4.03
Recommended Phase 2 Dose (RP2D) of F06 Formulation In Pediatric Participants Able To Swallow Intact Capsules
Assessed by NCI CTCAE v4.03
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
Recommended Phase 2 Dose (RP2D) Of Minitablets/F15 Formulation In Pediatric Participants Unable To Swallow Intact Capsules
Assessed by NCI CTCAE v4.03
Cohort B: Objective Response Rate (ORR)
Assessed by RANO per the BICR
Cohort D: ORR
Assessed by RECIST v1.1 per the BICR

Secondary Outcome Measures

Safety and Tolerability - AE, ECG and Labs assessed by NCI CTCAE v4.03
AE, ECG and Labs assessed by NCI CTCAE v4.03
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
Cohort A, D, or E: Clinical Benefit Rate (CBR)
Assessed by RECIST v1.1 per the BICR and investigator
Cohort B or E: CBR
Assessed by RANO per the BICR and investigator
Cohort C: CBR
Assessed by the Curie scale per the BICR and investigator
Cohort A, D, or E: Progression-free Survival (PFS)
Assessed by RECIST v1.1 per the BICR and investigator
Cohort B or E: PFS
Assessed by RANO per the BICR and investigator
Cohort C: PFS
Assessed by the Curie scale per the BICR and investigator
Cohort A, D, or E: Overall Survival (OS)
Assessed by RECIST v1.1
Cohort B or E: OS
Assessed by RANO
Cohort A, D, or E: ORR
Assessed by RECIST v1.1 per the BICR and investigator
Cohort B or E: ORR
Assessed by RANO per the BICR and investigator
Cohort C: ORR
Assessed by the Curie scale per the BICR and investigator
Cohort A, D, or E: Time to response (TTR)
Assessed by RECIST v1.1 per the BICR and investigator
Cohort B or E: TTR
Assessed by RANO per the BICR and investigator
Cohort C: TTR
Assessed by the Curie scale per the BICR and investigator
Cohort A, D, or E: Duration of Response (DOR)
Assessed by RECIST v1.1 per the BICR and investigator
Cohort B or E: DOR
Assessed by RANO per the BICR and investigator
Cohort C: DOR
Assessed by the Curie scale per the BICR and investigator
Phase 2 Participants with NTRK1/2/3 or ROS1 gene fusions (Cohort B or E): ORR
Assessed by RANO per the investigator
Phase 2 Participants with NTRK1/2/3 or ROS1 gene fusions (Cohort D or E): ORR
Assessed by RECIST v1.1 per the investigator
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
Phase 1/2 Participants with NTRK1/2/3 gene fusions (Cohort B or E): ORR
Assessed by RANO per the BICR and investigator
Phase 1/2 Participants with ROS1 gene fusions (Cohort A, D, or E): ORR
Assessed by RECIST v1.1 per the BICR and investigator
Phase 1/2 Participants with ROS1 gene fusions (Cohort B or E): ORR
Assessed by RANO per the BICR and investigator
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
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
Phase 2 Participants with NTRK1/2/3 or ROS1 gene fusions (Cohort B or E): DOR
Assessed by RANO per the BICR and investigator
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
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
Phase 1/2 Participants with NTRK1/2/3 gene fusions (Cohort B or E): DOR
Assessed by RANO per the BICR and investigator
Phase 1/2 Participants with ROS1 gene fusions (Cohort A, D, or E): DOR
Assessed by RECIST v1.1 per the BICR and investigator
Phase 1/2 Participants with ROS1 gene fusions (Cohort B or E): DOR
Assessed by RANO per the BICR and investigator
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
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
Phase 2 Participants with NTRK1/2/3 or ROS1 gene fusions (Cohort B or E): TTR
Assessed by RANO per the BICR and investigator
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
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
Phase 1/2 Participants with NTRK1/2/3 gene fusions (Cohort B or E): TTR
Assessed by RANO per the BICR and investigator
Phase 1/2 Participants with ROS1 gene fusions (Cohort A, D, or E): TTR
Assessed by RECIST v1.1 per the BICR and investigator
Phase 1/2 Participants with ROS1 gene fusions (Cohort B or E): TTR
Assessed by RANO per the BICR and investigator
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
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

Full Information

First Posted
January 4, 2016
Last Updated
October 5, 2023
Sponsor
Hoffmann-La Roche
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1. Study Identification

Unique Protocol Identification Number
NCT02650401
Brief Title
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
Acronym
STARTRK-NG
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
May 3, 2016 (Actual)
Primary Completion Date
December 15, 2022 (Actual)
Study Completion Date
June 15, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche

4. Oversight

Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Solid Tumors, CNS Tumors
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, CNS tumors, Sarcoma, Ewing sarcoma, Glial tumors, Salivary Gland Cancer (MASC), Papillary thyroid cancer, Medulloblastoma, Wilms tumor (anaplastic)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
69 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Extracranial solid tumors harboring NTRK1/2/3,
Arm Type
Active Comparator
Arm Description
Arm closed for further enrollment ROS1, ALK non-gene fusion molecular alterations Oral entrectinib (RXDX-101)
Arm Title
CNS tumors harboring- NTRK1/2/3, ROS1, ALK
Arm Type
Active Comparator
Arm Description
Arm closed for further enrollment molecular alterations, including gene fusions Oral entrectinib (RXDX-101)
Arm Title
Neuroblastoma
Arm Type
Active Comparator
Arm Description
Arm closed for further enrollment Oral entrectinib (RXDX-101)
Arm Title
Non-neuroblastoma, extracranial solid tumors
Arm Type
Active Comparator
Arm Description
Arm closed for further enrollment harboring - NTRK1/2/3, ROS1, ALK gene fusions Oral entrectinib (RXDX-101)
Arm Title
Any participant unable to swallow capsules
Arm Type
Active Comparator
Arm Description
Arm closed for further enrollment Any participant who otherwise meet all other eligibility criteria Oral entrectinib (RXDX-101)
Arm Title
Expansion: CNS tumors harboring NTRK1/2/3, ROS1
Arm Type
Active Comparator
Arm Description
gene fusions Oral entrectinib (RXDX-101)
Arm Title
Expansion: Extracranial solid tumors harboring NTRK1/2/3, ROS1
Arm Type
Active Comparator
Arm Description
NTRK 1,2,3 and ROS1 fusions Oral entrectinib (RXDX-101)
Intervention Type
Drug
Intervention Name(s)
Entrectinib
Other Intervention Name(s)
RXDX-101
Intervention Description
TRKA/B/C, ROS1, and ALK inhibitor
Primary Outcome Measure Information:
Title
Maximum Tolerated Dose (MTD)
Description
Assessed by National Cancer Institute Common Terminology for Adverse Events Criteria (NCI CTCAE v4.03)
Time Frame
Approximately 6 months
Title
Recommended Phase 2 Dose (RP2D) of F1 Formulation In Pediatric Participants Able To Swallow Intact Capsules
Description
Assessed by NCI CTCAE v4.03
Time Frame
Approximately 6 months
Title
Recommended Phase 2 Dose (RP2D) of F06 Formulation In Pediatric Participants Able To Swallow Intact Capsules
Description
Assessed by NCI CTCAE v4.03
Time Frame
Approximately 6 months
Title
Recommended Phase 2 Dose (RP2D) of F06 Formulation In Pediatric In Participants Dosed Via Feeding Tube (Nasogastric Tube Or Gastric Tube)
Description
Assessed by NCI CTCAE v4.03
Time Frame
Approximately 6 months
Title
Recommended Phase 2 Dose (RP2D) Of Minitablets/F15 Formulation In Pediatric Participants Unable To Swallow Intact Capsules
Description
Assessed by NCI CTCAE v4.03
Time Frame
Approximately 6 months
Title
Cohort B: Objective Response Rate (ORR)
Description
Assessed by RANO per the BICR
Time Frame
Approximately 6 months
Title
Cohort D: ORR
Description
Assessed by RECIST v1.1 per the BICR
Time Frame
Approximately 6 months
Secondary Outcome Measure Information:
Title
Safety and Tolerability - AE, ECG and Labs assessed by NCI CTCAE v4.03
Description
AE, ECG and Labs assessed by NCI CTCAE v4.03
Time Frame
Approximately 24 months
Title
Maximum observed plasma drug concentration (Cmax) using F1 Formulation
Description
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
Time Frame
Approximately 24 months
Title
Maximum observed plasma drug concentration (Cmax) using F06 Formulation given intact
Description
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
Time Frame
Approximately 24 months
Title
Maximum observed plasma drug concentration (Cmax) using F06 Formulation administered via feeding tube
Description
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
Time Frame
Approximately 24 months
Title
Maximum observed plasma drug concentration (Cmax) using minitablets/F15
Description
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
Time Frame
Approximately 24 months
Title
Time to Cmax, by inspection (Tmax) using F1 Formulation
Description
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
Time Frame
Approximately 24 months
Title
Time to Cmax, by inspection (Tmax) using F06 Formulation given intact
Description
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
Time Frame
Approximately 24 months
Title
Time to Cmax, by inspection (Tmax) using F06 Formulation administered via feeding tube
Description
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
Time Frame
Approximately 24 months
Title
Time to Cmax, by inspection (Tmax) using minitablets/F15
Description
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
Time Frame
Approximately 24 months
Title
AUC at steady state (AUCss) using F1 Formulation
Description
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
Time Frame
Approximately 24 months
Title
AUC at steady state (AUCss) using F06 Formulation given intact
Description
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
Time Frame
Approximately 24 months
Title
AUC at steady state (AUCss) using F06 Formulation administered via feeding tube
Description
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
Time Frame
Approximately 24 months
Title
AUC at steady state (AUCss) using minitablets/F15
Description
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
Time Frame
Approximately 24 months
Title
Terminal half life (t½) using F1 Formulation
Description
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
Time Frame
Approximately 24 months
Title
Terminal half life (t½) using F06 Formulation given intact
Description
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
Time Frame
Approximately 24 months
Title
Terminal half life (t½) using F06 Formulation administered via feeding tube
Description
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
Time Frame
Approximately 24 months
Title
Terminal half life (t½) using minitablets/F15
Description
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
Time Frame
Approximately 24 months
Title
Area under the drug concentration by time curve (AUC) using F1 Formulation
Description
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
Time Frame
Approximately 24 months
Title
Area under the drug concentration by time curve (AUC) using F06 Formulation given intact
Description
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
Time Frame
Approximately 24 months
Title
Area under the drug concentration by time curve (AUC) using F06 Formulation administered via feeding tube
Description
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
Time Frame
Approximately 24 months
Title
Area under the drug concentration by time curve (AUC) using minitablets/F15
Description
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
Time Frame
Approximately 24 months
Title
Cohort A, D, or E: Clinical Benefit Rate (CBR)
Description
Assessed by RECIST v1.1 per the BICR and investigator
Time Frame
Approximately 6 months
Title
Cohort B or E: CBR
Description
Assessed by RANO per the BICR and investigator
Time Frame
Approximately 6 months
Title
Cohort C: CBR
Description
Assessed by the Curie scale per the BICR and investigator
Time Frame
Approximately 6 months
Title
Cohort A, D, or E: Progression-free Survival (PFS)
Description
Assessed by RECIST v1.1 per the BICR and investigator
Time Frame
Approximately 6 months
Title
Cohort B or E: PFS
Description
Assessed by RANO per the BICR and investigator
Time Frame
Approximately 6 months
Title
Cohort C: PFS
Description
Assessed by the Curie scale per the BICR and investigator
Time Frame
Approximately 6 months
Title
Cohort A, D, or E: Overall Survival (OS)
Description
Assessed by RECIST v1.1
Time Frame
Approximately 6 months
Title
Cohort B or E: OS
Description
Assessed by RANO
Time Frame
Approximately 6 months
Title
Cohort A, D, or E: ORR
Description
Assessed by RECIST v1.1 per the BICR and investigator
Time Frame
Approximately 6 months
Title
Cohort B or E: ORR
Description
Assessed by RANO per the BICR and investigator
Time Frame
Approximately 6 months
Title
Cohort C: ORR
Description
Assessed by the Curie scale per the BICR and investigator
Time Frame
Approximately 6 months
Title
Cohort A, D, or E: Time to response (TTR)
Description
Assessed by RECIST v1.1 per the BICR and investigator
Time Frame
Approximately 6 months
Title
Cohort B or E: TTR
Description
Assessed by RANO per the BICR and investigator
Time Frame
Approximately 6 months
Title
Cohort C: TTR
Description
Assessed by the Curie scale per the BICR and investigator
Time Frame
Approximately 6 months
Title
Cohort A, D, or E: Duration of Response (DOR)
Description
Assessed by RECIST v1.1 per the BICR and investigator
Time Frame
Approximately 6 months
Title
Cohort B or E: DOR
Description
Assessed by RANO per the BICR and investigator
Time Frame
Approximately 6 months
Title
Cohort C: DOR
Description
Assessed by the Curie scale per the BICR and investigator
Time Frame
Approximately 6 months
Title
Phase 2 Participants with NTRK1/2/3 or ROS1 gene fusions (Cohort B or E): ORR
Description
Assessed by RANO per the investigator
Time Frame
Approximately 6 months
Title
Phase 2 Participants with NTRK1/2/3 or ROS1 gene fusions (Cohort D or E): ORR
Description
Assessed by RECIST v1.1 per the investigator
Time Frame
Approximately 6 months
Title
Phase 1/2 Participants with NTRK1/2/3 gene fusions (Cohort A, D, or E): ORR
Description
Assessed by RECIST v1.1 per the BICR and investigator
Time Frame
Approximately 6 months
Title
Phase 1/2 Participants with NTRK1/2/3 gene fusions (Cohort B or E): ORR
Description
Assessed by RANO per the BICR and investigator
Time Frame
Approximately 6 months
Title
Phase 1/2 Participants with ROS1 gene fusions (Cohort A, D, or E): ORR
Description
Assessed by RECIST v1.1 per the BICR and investigator
Time Frame
Approximately 6 months
Title
Phase 1/2 Participants with ROS1 gene fusions (Cohort B or E): ORR
Description
Assessed by RANO per the BICR and investigator
Time Frame
Approximately 6 months
Title
Phase 1/2 Participants with NTRK1/2/3 or ROS1 gene fusions (Cohort A, D, or E): ORR
Description
Assessed by RECIST v1.1 per the BICR and investigator
Time Frame
Approximately 6 months
Title
Phase 1/2 Participants with NTRK1/2/3 or ROS1 gene fusions (Cohort B or E): ORR
Description
Assessed by RANO per the BICR and investigator
Time Frame
Approximately 6 months
Title
Phase 2 Participants with NTRK1/2/3 or ROS1 gene fusions (Cohort B or E): DOR
Description
Assessed by RANO per the BICR and investigator
Time Frame
Approximately 6 months
Title
Phase 2 Participants with NTRK1/2/3 or ROS1 gene fusions (Cohort D or E): DOR
Description
Assessed by RECIST v1.1 per the BICR and investigator
Time Frame
Approximately 6 months
Title
Phase 1/2 Participants with NTRK1/2/3 gene fusions (Cohort A, D, or E): DOR
Description
Assessed by RECIST v1.1 per the BICR and investigator
Time Frame
Approximately 6 months
Title
Phase 1/2 Participants with NTRK1/2/3 gene fusions (Cohort B or E): DOR
Description
Assessed by RANO per the BICR and investigator
Time Frame
Approximately 6 months
Title
Phase 1/2 Participants with ROS1 gene fusions (Cohort A, D, or E): DOR
Description
Assessed by RECIST v1.1 per the BICR and investigator
Time Frame
Approximately 6 months
Title
Phase 1/2 Participants with ROS1 gene fusions (Cohort B or E): DOR
Description
Assessed by RANO per the BICR and investigator
Time Frame
Approximately 6 months
Title
Phase 1/2 Participants with NTRK1/2/3 or ROS1 gene fusions (Cohort A, D, or E): DOR
Description
Assessed by RECIST v1.1 per the BICR and investigator
Time Frame
Approximately 6 months
Title
Phase 1/2 Participants with NTRK1/2/3 or ROS1 gene fusions (Cohort B or E): DOR
Description
Assessed by RANO per the BICR and investigator
Time Frame
Approximately 6 months
Title
Phase 2 Participants with NTRK1/2/3 or ROS1 gene fusions (Cohort B or E): TTR
Description
Assessed by RANO per the BICR and investigator
Time Frame
Approximately 6 months
Title
Phase 2 Participants with NTRK1/2/3 or ROS1 gene fusions (Cohort D or E): TTR
Description
Assessed by RECIST v1.1 per the BICR and investigator
Time Frame
Approximately 6 months
Title
Phase 1/2 Participants with NTRK1/2/3 gene fusions (Cohort A, D, or E): TTR
Description
Assessed by RECIST v1.1 per the BICR and investigator
Time Frame
Approximately 6 months
Title
Phase 1/2 Participants with NTRK1/2/3 gene fusions (Cohort B or E): TTR
Description
Assessed by RANO per the BICR and investigator
Time Frame
Approximately 6 months
Title
Phase 1/2 Participants with ROS1 gene fusions (Cohort A, D, or E): TTR
Description
Assessed by RECIST v1.1 per the BICR and investigator
Time Frame
Approximately 6 months
Title
Phase 1/2 Participants with ROS1 gene fusions (Cohort B or E): TTR
Description
Assessed by RANO per the BICR and investigator
Time Frame
Approximately 6 months
Title
Phase 1/2 Participants with NTRK1/2/3 or ROS1 gene fusions (Cohort A, D, or E): TTR
Description
Assessed by RECIST v1.1 per the BICR and investigator
Time Frame
Approximately 6 months
Title
Phase 1/2 Participants with NTRK1/2/3 or ROS1 gene fusions (Cohort B or E): TTR
Description
Assessed by RANO per the BICR and investigator
Time Frame
Approximately 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
0 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 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 Exclusion Criteria: 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. 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
Facility Information:
Facility Name
Children'S Hospital of Orange County
City
Orange
State/Province
California
ZIP/Postal Code
92868-3874
Country
United States
Facility Name
Rady Childrens Hospital
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
UCSF Benioff Children's Hospital; UCSF Pediatrics Hematology Oncology
City
San Francisco
State/Province
California
ZIP/Postal Code
94158
Country
United States
Facility Name
Children's Hospital Colorado; Center For Cancer/Blood Disorder
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Children's National Medical Center; Department of Pediatrics
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20037
Country
United States
Facility Name
Egleston Children's Hospital at Emory University Atlanta; Pediatric Hematology/Oncology
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
University of Chicago; Comer Children's Hospital/Department of Pediatrics
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Johns Hopkins University
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21205
Country
United States
Facility Name
Dana Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
University of Minnesota Childrens' Hospital
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Facility Name
Washington University,St. Louis Children's Hospital; Neurology, Movement Disorder
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Morgan Stanley Children's Hospital; Herbert Irving Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Memorial Sloan Kettering Cancer Center; Pediatrics
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
Cincinnati Children's Hospital Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229
Country
United States
Facility Name
Nationwide Children's Hospital; Dept. of Pulmonology
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43205
Country
United States
Facility Name
Oregon Health & Science Uni
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
Children's Hospital of Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
St. Jude Children'S Research Hospital
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38105
Country
United States
Facility Name
Cook Childrens Medical Center
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
Facility Name
Texas Children's Cancer and Hematology Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Primary Children's Hospital
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84113
Country
United States
Facility Name
The Hospital for Sick Children
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1X8
Country
Canada
Facility Name
Beijing Children's Hospital, Capital Medical University; Oncological Surgery Department
City
Beijing City
ZIP/Postal Code
100032
Country
China
Facility Name
Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
City
Shanghai
ZIP/Postal Code
200092
Country
China
Facility Name
Centre Leon Berard; Pediatrie
City
Lyon
ZIP/Postal Code
69373
Country
France
Facility Name
Hôpital de la Timone, Oncologie Pédiatrique
City
Marseille
ZIP/Postal Code
13385
Country
France
Facility Name
Hopital Purpan; Pediatrie - Hematologie - Oncologie pediatrique
City
Toulouse
ZIP/Postal Code
31500
Country
France
Facility Name
Institut Gustave Roussy; Service de Pathologie Morphologique
City
Villejuif
ZIP/Postal Code
94805
Country
France
Facility Name
Universitaetsklinikum Heidelberg
City
Heidelberg
ZIP/Postal Code
69120
Country
Germany
Facility Name
Hong Kong Children's Hospital
City
Hong Kong
Country
Hong Kong
Facility Name
Fondazione IRCCS Istituto Nazionale dei Tumori; Struttura Complessa di Pediatria Oncologica
City
Milano
State/Province
Lombardia
ZIP/Postal Code
20133
Country
Italy
Facility Name
A. O. Città della Salute e della Scienza di Torino; SC Oncoematologia e Centro Trapianti AOOIRM
City
Torino
State/Province
Piemonte
ZIP/Postal Code
10126
Country
Italy
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Facility Name
Hospital Sant Joan de Deu; Servicio de Oncologia y Hematologia
City
Esplugues de Llobregat
State/Province
Barcelona
ZIP/Postal Code
08950
Country
Spain
Facility Name
Hospital Infantil Universitario Nino Jesus
City
Madrid
ZIP/Postal Code
28009
Country
Spain
Facility Name
National Taiwan University Hospital; Department of Paediatrics
City
Taipei
ZIP/Postal Code
100
Country
Taiwan
Facility Name
Chang Gung Memorial Hospital, Linkou; Department of Pediatric Internal Medicine
City
Taoyuan City
ZIP/Postal Code
333
Country
Taiwan
Facility Name
Leeds General Infirmary
City
Leeds
ZIP/Postal Code
LS1 3EX
Country
United Kingdom
Facility Name
Royal Victoria Infirmary; Pharmacy
City
Newcastle upon Tyne
ZIP/Postal Code
NE1 4LP
Country
United Kingdom
Facility Name
Royal Marsden NHS Foundation Trust
City
Sutton
ZIP/Postal Code
SM2 5PT
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
35395680
Citation
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.
Results Reference
derived
PubMed Identifier
31838007
Citation
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.
Results Reference
derived

Learn more about this trial

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

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