- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02650401
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)
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 Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Locations
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Ontario
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Toronto, Ontario, Canada, M5G 1X8
- The Hospital for Sick Children
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Beijing City, China, 100032
- Beijing Children's Hospital, Capital Medical University; Oncological Surgery Department
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Shanghai, China, 200092
- Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
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Lyon, France, 69373
- Centre Leon Berard; Pediatrie
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Marseille, France, 13385
- Hôpital de la Timone, Oncologie Pédiatrique
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Toulouse, France, 31500
- Hopital Purpan; Pediatrie - Hematologie - Oncologie pediatrique
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Villejuif, France, 94805
- Institut Gustave Roussy; Service de Pathologie Morphologique
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Heidelberg, Germany, 69120
- Universitaetsklinikum Heidelberg
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Hong Kong, Hong Kong
- Hong Kong Children's Hospital
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Lombardia
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Milano, Lombardia, Italy, 20133
- Fondazione IRCCS Istituto Nazionale dei Tumori; Struttura Complessa di Pediatria Oncologica
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Piemonte
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Torino, Piemonte, Italy, 10126
- A. O. Città della Salute e della Scienza di Torino; SC Oncoematologia e Centro Trapianti AOOIRM
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Seoul, Korea, Republic of, 03080
- Seoul National University Hospital
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Madrid, Spain, 28009
- Hospital Infantil Universitario Niño Jesús
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Barcelona
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Esplugues de Llobregat, Barcelona, Spain, 08950
- Hospital Sant Joan de Deu; Servicio de Oncologia y Hematologia
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Taipei, Taiwan, 100
- National Taiwan University Hospital; Department of Paediatrics
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Taoyuan City, Taiwan, 333
- Chang Gung Memorial Hospital, Linkou; Department of Pediatric Internal Medicine
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Leeds, United Kingdom, LS1 3EX
- Leeds General Infirmary
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Newcastle upon Tyne, United Kingdom, NE1 4LP
- Royal Victoria Infirmary; Pharmacy
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Sutton, United Kingdom, SM2 5PT
- Royal Marsden NHS Foundation Trust
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California
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Orange, California, United States, 92868-3874
- Children's Hospital of Orange County
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San Diego, California, United States, 92123
- Rady Childrens Hospital
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San Francisco, California, United States, 94158
- UCSF Benioff Children's Hospital; UCSF Pediatrics Hematology Oncology
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Colorado
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Aurora, Colorado, United States, 80045
- Children's Hospital Colorado; Center For Cancer/Blood Disorder
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District of Columbia
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Washington, District of Columbia, United States, 20037
- Children's National Medical Center; Department of Pediatrics
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Georgia
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Atlanta, Georgia, United States, 30322
- Egleston Children's Hospital at Emory University Atlanta; Pediatric Hematology/Oncology
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Illinois
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Chicago, Illinois, United States, 60637
- University of Chicago; Comer Children's Hospital/Department of Pediatrics
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Maryland
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Baltimore, Maryland, United States, 21205
- Johns Hopkins University
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Massachusetts
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Boston, Massachusetts, United States, 02215
- Dana Farber Cancer Institute
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Minnesota
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Minneapolis, Minnesota, United States, 55455
- University of Minnesota Childrens' Hospital
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Missouri
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Saint Louis, Missouri, United States, 63110
- Washington University,St. Louis Children's Hospital; Neurology, Movement Disorder
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New York
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New York, New York, United States, 10032
- Morgan Stanley Children's Hospital; Herbert Irving Cancer Center
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New York, New York, United States, 10065
- Memorial Sloan Kettering Cancer Center; Pediatrics
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Ohio
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Cincinnati, Ohio, United States, 45229
- Cincinnati Children's Hospital Medical Center
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Columbus, Ohio, United States, 43205
- Nationwide Children's Hospital; Dept. of Pulmonology
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Oregon
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Portland, Oregon, United States, 97239
- Oregon Health & Science Uni
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19104
- Children's Hospital of Philadelphia
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Tennessee
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Memphis, Tennessee, United States, 38105
- St. Jude Children's Research Hospital
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Texas
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Fort Worth, Texas, United States, 76104
- Cook Childrens Medical Center
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Houston, Texas, United States, 77030
- Texas Children's Cancer and Hematology Center
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Utah
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Salt Lake City, Utah, United States, 84113
- Primary Children's Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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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) |
TRKA/B/C, ROS1, and ALK inhibitor
Other Names:
|
Active Comparator: CNS tumors harboring- NTRK1/2/3, ROS1, ALK
Arm closed for further enrollment molecular alterations, including gene fusions Oral entrectinib (RXDX-101) |
TRKA/B/C, ROS1, and ALK inhibitor
Other Names:
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Active Comparator: Neuroblastoma
Arm closed for further enrollment Oral entrectinib (RXDX-101) |
TRKA/B/C, ROS1, and ALK inhibitor
Other Names:
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Active Comparator: Non-neuroblastoma, extracranial solid tumors
Arm closed for further enrollment harboring - NTRK1/2/3, ROS1, ALK gene fusions Oral entrectinib (RXDX-101) |
TRKA/B/C, ROS1, and ALK inhibitor
Other Names:
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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) |
TRKA/B/C, ROS1, and ALK inhibitor
Other Names:
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Active Comparator: Expansion: CNS tumors harboring NTRK1/2/3, ROS1
gene fusions Oral entrectinib (RXDX-101) |
TRKA/B/C, ROS1, and ALK inhibitor
Other Names:
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Active Comparator: Expansion: Extracranial solid tumors harboring NTRK1/2/3, ROS1
NTRK 1,2,3 and ROS1 fusions Oral entrectinib (RXDX-101) |
TRKA/B/C, ROS1, and ALK inhibitor
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Maximum Tolerated Dose (MTD)
Time Frame: Approximately 6 months
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Assessed by National Cancer Institute Common Terminology for Adverse Events Criteria (NCI CTCAE v4.03)
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Approximately 6 months
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Recommended Phase 2 Dose (RP2D) of F1 Formulation In Pediatric Participants Able To Swallow Intact Capsules
Time Frame: Approximately 6 months
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Assessed by NCI CTCAE v4.03
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Approximately 6 months
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Recommended Phase 2 Dose (RP2D) of F06 Formulation In Pediatric Participants Able To Swallow Intact Capsules
Time Frame: Approximately 6 months
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Assessed by NCI CTCAE v4.03
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Approximately 6 months
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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
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Assessed by NCI CTCAE v4.03
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Approximately 6 months
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Recommended Phase 2 Dose (RP2D) Of Minitablets/F15 Formulation In Pediatric Participants Unable To Swallow Intact Capsules
Time Frame: Approximately 6 months
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Assessed by NCI CTCAE v4.03
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Approximately 6 months
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Cohort B: Objective Response Rate (ORR)
Time Frame: Approximately 6 months
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Assessed by RANO per the BICR
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Approximately 6 months
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Cohort D: ORR
Time Frame: Approximately 6 months
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Assessed by RECIST v1.1 per the BICR
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Approximately 6 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Safety and Tolerability - AE, ECG and Labs assessed by NCI CTCAE v4.03
Time Frame: Approximately 24 months
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AE, ECG and Labs assessed by NCI CTCAE v4.03
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Approximately 24 months
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Maximum observed plasma drug concentration (Cmax) using F1 Formulation
Time Frame: Approximately 24 months
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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
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Approximately 24 months
|
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
|
Approximately 24 months
|
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
|
Approximately 24 months
|
Maximum observed plasma drug concentration (Cmax) using minitablets/F15
Time Frame: Approximately 24 months
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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
|
Approximately 24 months
|
Time to Cmax, by inspection (Tmax) using F1 Formulation
Time Frame: Approximately 24 months
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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
|
Approximately 24 months
|
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
|
Approximately 24 months
|
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
|
Approximately 24 months
|
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
|
Approximately 24 months
|
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
|
Approximately 24 months
|
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
|
Approximately 24 months
|
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
|
Approximately 24 months
|
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
|
Approximately 24 months
|
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
|
Approximately 24 months
|
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
|
Approximately 24 months
|
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
|
Approximately 24 months
|
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
|
Approximately 24 months
|
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
|
Approximately 24 months
|
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
|
Approximately 24 months
|
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
|
Approximately 24 months
|
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
|
Approximately 24 months
|
Cohort A, D, or E: Clinical Benefit Rate (CBR)
Time Frame: Approximately 6 months
|
Assessed by RECIST v1.1 per the BICR and investigator
|
Approximately 6 months
|
Cohort B or E: CBR
Time Frame: Approximately 6 months
|
Assessed by RANO per the BICR and investigator
|
Approximately 6 months
|
Cohort C: CBR
Time Frame: Approximately 6 months
|
Assessed by the Curie scale per the BICR and investigator
|
Approximately 6 months
|
Cohort A, D, or E: Progression-free Survival (PFS)
Time Frame: Approximately 6 months
|
Assessed by RECIST v1.1 per the BICR and investigator
|
Approximately 6 months
|
Cohort B or E: PFS
Time Frame: Approximately 6 months
|
Assessed by RANO per the BICR and investigator
|
Approximately 6 months
|
Cohort C: PFS
Time Frame: Approximately 6 months
|
Assessed by the Curie scale per the BICR and investigator
|
Approximately 6 months
|
Cohort A, D, or E: Overall Survival (OS)
Time Frame: Approximately 6 months
|
Assessed by RECIST v1.1
|
Approximately 6 months
|
Cohort B or E: OS
Time Frame: Approximately 6 months
|
Assessed by RANO
|
Approximately 6 months
|
Cohort A, D, or E: ORR
Time Frame: Approximately 6 months
|
Assessed by RECIST v1.1 per the BICR and investigator
|
Approximately 6 months
|
Cohort B or E: ORR
Time Frame: Approximately 6 months
|
Assessed by RANO per the BICR and investigator
|
Approximately 6 months
|
Cohort C: ORR
Time Frame: Approximately 6 months
|
Assessed by the Curie scale per the BICR and investigator
|
Approximately 6 months
|
Cohort A, D, or E: Time to response (TTR)
Time Frame: Approximately 6 months
|
Assessed by RECIST v1.1 per the BICR and investigator
|
Approximately 6 months
|
Cohort B or E: TTR
Time Frame: Approximately 6 months
|
Assessed by RANO per the BICR and investigator
|
Approximately 6 months
|
Cohort C: TTR
Time Frame: Approximately 6 months
|
Assessed by the Curie scale per the BICR and investigator
|
Approximately 6 months
|
Cohort A, D, or E: Duration of Response (DOR)
Time Frame: Approximately 6 months
|
Assessed by RECIST v1.1 per the BICR and investigator
|
Approximately 6 months
|
Cohort B or E: DOR
Time Frame: Approximately 6 months
|
Assessed by RANO per the BICR and investigator
|
Approximately 6 months
|
Cohort C: DOR
Time Frame: Approximately 6 months
|
Assessed by the Curie scale per the BICR and investigator
|
Approximately 6 months
|
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
|
Approximately 6 months
|
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
|
Approximately 6 months
|
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
|
Approximately 6 months
|
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
|
Approximately 6 months
|
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
|
Approximately 6 months
|
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
|
Approximately 6 months
|
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
|
Approximately 6 months
|
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
|
Approximately 6 months
|
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
|
Approximately 6 months
|
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
|
Approximately 6 months
|
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
|
Approximately 6 months
|
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
|
Approximately 6 months
|
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
|
Approximately 6 months
|
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
|
Approximately 6 months
|
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
|
Approximately 6 months
|
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
|
Approximately 6 months
|
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
|
Approximately 6 months
|
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
|
Approximately 6 months
|
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
|
Approximately 6 months
|
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
|
Approximately 6 months
|
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
|
Approximately 6 months
|
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
|
Approximately 6 months
|
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
|
Approximately 6 months
|
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
|
Approximately 6 months
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Clinical Trials, Hoffmann-La Roche
Publications and helpful links
General Publications
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
- Pediatric
- Relapsed
- Refractory
- Ewing sarcoma
- Medulloblastoma
- Solid Tumor
- Metastatic Cancer
- Sarcoma
- Neuroblastoma
- Papillary thyroid cancer
- CNS tumors
- ROS1
- NTRK
- ALK
- Brain tumors
- NTRK1
- NTRK2
- NTRK3
- TRK
- Tyrosine kinase
- Gene rearrangement
- Infantile fibrosarcoma
- Secretory breast cancer
- Congenital mesoblastic nephroma
- Pontine glioma
- Glial tumors
- Salivary Gland Cancer (MASC)
- Wilms tumor (anaplastic)
Additional Relevant MeSH Terms
Other Study ID Numbers
- RXDX-101-03
- CO40778 (Other Identifier: Hoffmann-La Roche)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Solid Tumors
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Incyte CorporationRecruitingA Study to Evaluate the Safety of INCA33890 in Participants With Advanced or Metastatic Solid TumorsAdvanced Solid Tumors | Solid Tumors | Metastatic Solid TumorsUnited States, Spain, United Kingdom, France, Italy, Denmark, Switzerland
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National Cancer Institute (NCI)RecruitingSolid Tumor | Refractory Solid Tumors | Malignant Solid Tumors | Other Neoplasms Solid Tumors | Pediatric Solid TumorUnited States
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Incyte Biosciences Japan GKCompletedAdvanced Solid Tumors | Metastatic Solid TumorsJapan
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Memorial Sloan Kettering Cancer CenterKyowa Hakko Kirin Pharma, Inc.CompletedAdvanced Solid Tumors | Metastatic Solid TumorsUnited States
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Bristol-Myers SquibbCompletedAdvanced Solid Tumors | Metastatic Solid TumorsKorea, Republic of, Canada, Australia
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Hoffmann-La RocheCompletedSolid Tumors, Advanced Solid TumorsUnited States
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Esperance Pharmaceuticals IncCompletedAdvanced Solid Tumors | Solid TumorsUnited States
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AmgenCompletedCancer | Advanced Solid Tumors | Solid Tumors | Tumors | Advanced MalignancyUnited States, Australia
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NantCell, Inc.CompletedQUILT-2.016: Study of AMG 479 With Biologics or Chemotherapy for Subjects With Advanced Solid TumorsCancer | Advanced Solid Tumors | Solid Tumors | Tumors | Advanced Malignancy
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NeuPharma, Inc.RecruitingLocally Advanced Solid Tumors | Metastatic Solid TumorsUnited States
Clinical Trials on Entrectinib
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Genentech, Inc.Completed
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Genentech, Inc.CompletedSolid TumorUnited Kingdom
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Genentech, Inc.Completed
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Hoffmann-La RocheCompletedHepatic InsufficiencyHungary, Czechia, Slovakia
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Arkadiusz Z. Dudek, MDGenentech, Inc.; Vanquish Oncology, Inc.; HealthPartners Regions Cancer Care... and other collaboratorsTerminatedUveal MelanomaUnited States
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Hoffmann-La RocheNo longer availableCancers With NTRK, ROS1, or ALK Gene FusionsUnited States
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Hoffmann-La RocheActive, not recruitingMelanoma | Renal Cell Carcinoma | Adult Solid Tumor | Breast Cancer | Head and Neck Neoplasms | Colorectal Cancer | Pancreatic Cancer | Ovarian Cancer | Non-Small Cell Lung Cancer | Neuroendocrine Tumors | Lymphoma, Large-Cell, Anaplastic | Cholangiocarcinoma | Papillary Thyroid Cancer | Sarcomas | Salivary Gland Cancers and other conditionsUnited States, China, Korea, Republic of, Australia, Taiwan, France, Spain, United Kingdom, Hong Kong, Belgium, Italy, Germany, Japan, Singapore, Netherlands, Poland
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Cancer Research UKRoyal Marsden NHS Foundation Trust; Hoffmann-La Roche; University of Manchester; University of BirminghamRecruitingGlioma | Melanoma | Neoplasms by Histologic Type | Lymphoproliferative Disorders | Neoplasms by Site | Cancer | Brain Neoplasms | Solid Tumor | Malignant Neoplasm | Malignancy | Haematological MalignancyUnited Kingdom
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Hoffmann-La RocheCompletedLocally Advanced Solid Tumors | Metastatic Solid TumorsUnited States, Korea, Republic of
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Hoffmann-La RocheRecruitingCarcinoma, Non-Small-Cell LungChina, France, Croatia, Brazil, Greece, Italy, Mexico, Spain, India, Netherlands, Romania, Sweden, Lebanon, Turkey, Slovakia, Jordan, Russian Federation