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JOURNAL ONKOLOGIE – STUDIE
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

Rekrutierend

NCT-Nummer:
NCT02650401

Studienbeginn:
Mai 2016

Letztes Update:
28.04.2021

Wirkstoff:
Entrectinib

Indikation (Clinical Trials):
Neoplasms, Central Nervous System Neoplasms

Geschlecht:
Alle

Altersgruppe:
Alle

Phase:
-

Sponsor:
Hoffmann-La Roche

Collaborator:
-

Studienleiter

Clinical Trials
Study Director
Hoffmann-La Roche

Kontakt

Reference Study ID Number: CO40778 www.roche.com/about_roche/roche_worldwide.htm
Kontakt:
Phone: 888-662-6728 (U.S. and Canada)
E-Mail: global-roche-genentech-trials@gene.com
» Kontaktdaten anzeigen

Studienlocations
(3 von 41)

Universitätsklinikum Heidelberg
69120 Heidelberg
(Baden-Württemberg)
GermanyRekrutierend» Google-Maps
Children'S Hospital of Orange County
92868-3874 Orange
United StatesAbgeschlossen» Google-Maps
Rady Childrens Hospital
92123 San Diego
United StatesRekrutierend» Google-Maps
UCSF Benioff Children's Hospital; UCSF Pediatrics Hematology Oncology
94158 San Francisco
United StatesRekrutierend» Google-Maps
Children's Hospital Colorado; Center For Cancer/Blood Disorder
80045 Aurora
United StatesRekrutierend» Google-Maps
Children's National Medical Center; Department of Pediatrics
20037 Washington
United StatesAbgeschlossen» Google-Maps
Egleston Children's Hospital at Emory University Atlanta; Pediatric Hematology/Oncology
30322 Atlanta
United StatesRekrutierend» Google-Maps
University of Chicago; Comer Children's Hospital/Department of Pediatrics
60637 Chicago
United StatesRekrutierend» Google-Maps
Johns Hopkins University
21205 Baltimore
United StatesRekrutierend» Google-Maps
Dana Farber Cancer Institute
02215 Boston
United StatesRekrutierend» Google-Maps
University of Minnesota Childrens' Hospital
55455 Minneapolis
United StatesAbgeschlossen» Google-Maps
Washington University,St. Louis Children's Hospital; Neurology, Movement Disorder
63110 Saint Louis
United StatesRekrutierend» Google-Maps
Morgan Stanley Children's Hospital; Herbert Irving Cancer Center
10032 New York
United StatesAbgeschlossen» Google-Maps
Memorial Sloan Kettering Cancer Center; Pediatrics
10065 New York
United StatesRekrutierend» Google-Maps
Cincinnati Children's Hospital Medical Center
45229 Cincinnati
United StatesRekrutierend» Google-Maps
Nationwide Children's Hospital; Dept. of Pulmonology
43205 Columbus
United StatesRekrutierend» Google-Maps
Oregon Health & Science Uni
97239 Portland
United StatesRekrutierend» Google-Maps
Children's Hospital of Philadelphia
19104 Philadelphia
United StatesRekrutierend» Google-Maps
St. Jude Children'S Research Hospital
38105 Memphis
United StatesRekrutierend» Google-Maps
Cook Childrens Medical Center
76104 Fort Worth
United StatesRekrutierend» Google-Maps
Texas Children's Cancer and Hematology Center
77030 Houston
United StatesRekrutierend» Google-Maps
Primary Children's Hospital
84113 Salt Lake City
United StatesRekrutierend» Google-Maps
The Hospital for Sick Children
M5G 1X8 Toronto
CanadaRekrutierend» Google-Maps
Beijing Children's Hospital, Capital Medical University; Oncological Surgery Department
100032 Beijing City
ChinaNoch nicht rekrutierend» Google-Maps
Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
200092 Shanghai
ChinaRekrutierend» Google-Maps
Hôpital de la Timone, Oncologie Pédiatrique
13385 Marseille
FranceRekrutierend» Google-Maps
Hopital Purpan; Pédiatrie - Hématologie - Oncologie pédiatrique
31500 Toulouse
FranceRekrutierend» Google-Maps
Institut Gustave Roussy; Service de Pathologie Morphologique
94805 Villejuif
FranceRekrutierend» Google-Maps
Hong Kong Children's Hospital
Hong Kong
Hong KongNoch nicht rekrutierend» Google-Maps
Fondazione IRCCS Istituto Nazionale dei Tumori; Struttura Complessa di Pediatria Oncologica
20133 Milano
ItalyRekrutierend» Google-Maps
A. O. Città della Salute e della Scienza di Torino; SC Oncoematologia e Centro Trapianti AOOIRM
10126 Torino
ItalyNoch nicht rekrutierend» Google-Maps
Azienda Ospedaliera di Padova; Clinica di Onco-ematologia pediatrica
35128 Padova
ItalyNoch nicht rekrutierend» Google-Maps
Seoul National University Hospital
03080 Seoul
Korea, Republic ofRekrutierend» Google-Maps
Hospital Sant Joan de Deu; Servicio de Oncologia y Hematologia
08950 Esplugues de Llobregat
SpainRekrutierend» Google-Maps
Hospital Infantil Universitario Niño Jesus; Servicio de Onco-hematologia
28009 Madrid
SpainRekrutierend» Google-Maps
National Taiwan University Hospital; Department of Paediatrics
100 Taipei
TaiwanRekrutierend» Google-Maps
Chang Gung Memorial Hospital, Linkou; Department of Pediatric Internal Medicine
333 Taoyuan City
TaiwanRekrutierend» Google-Maps
Leeds General Infirmary
LS1 3EX Leeds
United KingdomRekrutierend» Google-Maps
Royal Victoria Infirmary; Pharmacy
NE1 4LP Newcastle upon Tyne
United KingdomRekrutierend» Google-Maps
Royal Marsden NHS Foundation Trust
SM2 5PT Sutton
United KingdomRekrutierend» Google-Maps
Alle anzeigen

Studien-Informationen

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.

Ein-/Ausschlusskriterien

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.

Studien-Rationale

Primary outcome:

1. Maximum Tolerated Dose (MTD) (Time Frame - Approximately 6 months):
Assessed by National Cancer Institute Common Terminology for Adverse Events Criteria (NCI CTCAE v4.03)

2. Recommended Phase 2 Dose (RP2D) of F1 Formulation In Pediatric Participants Able To Swallow Intact Capsules (Time Frame - Approximately 6 months):
Assessed by NCI CTCAE v4.03

3. Recommended Phase 2 Dose (RP2D) of F06 Formulation In Pediatric Participants Able To Swallow Intact Capsules (Time Frame - Approximately 6 months):
Assessed by NCI CTCAE v4.03

4. Recommended Phase 2 Dose (RP2D) of F06 Formulation In Pediatric In Participants Dosed Via Feeding Tube (Nasogastric Tube Or Gastric Tube) (Time Frame - Approximately 6 months):
Assessed by NCI CTCAE v4.03

5. Recommended Phase 2 Dose (RP2D) Of Minitablets/F15 Formulation In Pediatric Participants Unable To Swallow Intact Capsules (Time Frame - Approximately 6 months):
Assessed by NCI CTCAE v4.03

6. Objective Response Rate (ORR) (Time Frame - Approximately 6 months):
Assessed by RECIST v1.1

Secondary outcome:

1. Safety and Tolerability - AE, ECG and Labs assessed by NCI CTCAE v4.03 (Time Frame - Approximately 24 months):
AE, ECG and Labs assessed by NCI CTCAE v4.03

2. Maximum observed plasma drug concentration (Cmax) using F1 Formulation (Time Frame - Approximately 24 months):
Assessed by plasma concentrations obtained on Days 1, 2, 8, 15, 22 (Cycle 1), Days 1, 2 (Cycle 2) and on Day 1 of every cycle thereafter

3. Maximum observed plasma drug concentration (Cmax) using F06 Formulation given intact (Time Frame - Approximately 24 months):
Assessed by plasma concentrations obtained on Days 1, 2, 8, 15, 22 (Cycle 1), Days 1, 2 (Cycle 2) and on Day 1 of every cycle thereafter

4. Maximum observed plasma drug concentration (Cmax) using F06 Formulation administered via feeding tube (Time Frame - Approximately 24 months):
Assessed by plasma concentrations obtained on Days 1, 2, 8, 15, 22 (Cycle 1), Days 1, 2 (Cycle 2) and on Day 1 of every cycle thereafter

5. Maximum observed plasma drug concentration (Cmax) using minitablets/F15 (Time Frame - Approximately 24 months):
Assessed by plasma concentrations obtained on Days 1, 2, 8, 15, 22 (Cycle 1), Days 1, 2 (Cycle 2) and on Day 1 of every cycle thereafter

6. Time to Cmax, by inspection (Tmax) using F1 Formulation (Time Frame - Approximately 24 months):
Assessed by plasma concentrations obtained on Days 1, 2, 8, 15, 22 (Cycle 1), Days 1, 2 (Cycle 2) and on Day 1 of every cycle thereafter

7. Time to Cmax, by inspection (Tmax) using F06 Formulation given intact (Time Frame - Approximately 24 months):
Assessed by plasma concentrations obtained on Days 1, 2, 8, 15, 22 (Cycle 1), Days 1, 2 (Cycle 2) and on Day 1 of every cycle thereafter

8. Time to Cmax, by inspection (Tmax) using F06 Formulation administered via feeding tube (Time Frame - Approximately 24 months):
Assessed by plasma concentrations obtained on Days 1, 2, 8, 15, 22 (Cycle 1), Days 1, 2 (Cycle 2) and on Day 1 of every cycle thereafter

9. Time to Cmax, by inspection (Tmax) using minitablets/F15 (Time Frame - Approximately 24 months):
Assessed by plasma concentrations obtained on Days 1, 2, 8, 15, 22 (Cycle 1), Days 1, 2 (Cycle 2) and on Day 1 of every cycle thereafter

10. AUC at steady state (AUCss) using F1 Formulation (Time Frame - Approximately 24 months):
Assessed by plasma concentrations obtained on Days 1, 2, 8, 15, 22 (Cycle 1), Days 1, 2 (Cycle 2) and on Day 1 of every cycle thereafter

11. AUC at steady state (AUCss) using F06 Formulation given intact (Time Frame - Approximately 24 months):
Assessed by plasma concentrations obtained on Days 1, 2, 8, 15, 22 (Cycle 1), Days 1, 2 (Cycle 2) and on Day 1 of every cycle thereafter

12. AUC at steady state (AUCss) using F06 Formulation administered via feeding tube (Time Frame - Approximately 24 months):
Assessed by plasma concentrations obtained on Days 1, 2, 8, 15, 22 (Cycle 1), Days 1, 2 (Cycle 2) and on Day 1 of every cycle thereafter

13. AUC at steady state (AUCss) using minitablets/F15 (Time Frame - Approximately 24 months):
Assessed by plasma concentrations obtained on Days 1, 2, 8, 15, 22 (Cycle 1), Days 1, 2 (Cycle 2) and on Day 1 of every cycle thereafter

14. Terminal half life (t½) using F1 Formulation (Time Frame - Approximately 24 months):
Assessed by plasma concentrations obtained on Days 1, 2, 8, 15, 22 (Cycle 1), Days 1, 2 (Cycle 2) and on Day 1 of every cycle thereafter

15. Terminal half life (t½) using F06 Formulation given intact (Time Frame - Approximately 24 months):
Assessed by plasma concentrations obtained on Days 1, 2, 8, 15, 22 (Cycle 1), Days 1, 2 (Cycle 2) and on Day 1 of every cycle thereafter

16. Terminal half life (t½) using F06 Formulation administered via feeding tube (Time Frame - Approximately 24 months):
Assessed by plasma concentrations obtained on Days 1, 2, 8, 15, 22 (Cycle 1), Days 1, 2 (Cycle 2) and on Day 1 of every cycle thereafter

17. Terminal half life (t½) using minitablets/F15 (Time Frame - Approximately 24 months):
Assessed by plasma concentrations obtained on Days 1, 2, 8, 15, 22 (Cycle 1), Days 1, 2 (Cycle 2) and on Day 1 of every cycle thereafter

18. Area under the drug concentration by time curve (AUC) using F1 Formulation (Time Frame - Approximately 24 months):
Assessed by plasma concentrations obtained on Days 1, 2, 8, 15, 22 (Cycle 1), Days 1, 2 (Cycle 2) and on Day 1 of every cycle thereafter

19. Area under the drug concentration by time curve (AUC) using F06 Formulation given intact (Time Frame - Approximately 24 months):
Assessed by plasma concentrations obtained on Days 1, 2, 8, 15, 22 (Cycle 1), Days 1, 2 (Cycle 2) and on Day 1 of every cycle thereafter

20. Area under the drug concentration by time curve (AUC) using F06 Formulation administered via feeding tube (Time Frame - Approximately 24 months):
Assessed by plasma concentrations obtained on Days 1, 2, 8, 15, 22 (Cycle 1), Days 1, 2 (Cycle 2) and on Day 1 of every cycle thereafter

21. Area under the drug concentration by time curve (AUC) using minitablets/F15 (Time Frame - Approximately 24 months):
Assessed by plasma concentrations obtained on Days 1, 2, 8, 15, 22 (Cycle 1), Days 1, 2 (Cycle 2) and on Day 1 of every cycle thereafter

22. Progression-free Survival (PFS) (Time Frame - Approximately 6 months):
Defined as time from the date of study enrollment to the first occurrence of objective disease progression or date of death due to any cause, whichever occurs first

23. Overall Survival (OS) (Time Frame - Approximately 6 months):
Assessed by RECIST v1.1

24. Duration of Response (DOR) (Time Frame - Approximately 6 months):
Assessed by RECIST v1.1

25. Time to response (TTR) (Time Frame - Approximately 6 months):
Assessed by RECIST v1.1

26. Clinical Benefit Rate (CBR) (Time Frame - Approximately 6 months):
Assessed by RECIST v1.1

Studien-Arme

  • 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)
  • Active Comparator: CNS tumors harboring- NTRK1/2/3, ROS1, ALK
    Arm closed for further enrollment molecular alterations, including gene fusions Oral entrectinib (RXDX-101)
  • Active Comparator: Neuroblastoma
    Arm closed for further enrollment Oral entrectinib (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)
  • 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)
  • Active Comparator: Expansion: CNS tumors harboring NTRK1/2/3, ROS1
    gene fusions Oral entrectinib (RXDX-101)
  • Active Comparator: Expansion: Extracranial solid tumors harboring NTRK1/2/3, ROS1
    NTRK 1,2,3 and ROS1 fusions Oral entrectinib (RXDX-101)

Geprüfte Regime

  • Entrectinib (RXDX-101):
    TRKA/B/C, ROS1, and ALK inhibitor

Quelle: ClinicalTrials.gov


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