Study of RXDX-101 in Children With Recurrent or Refractory Solid Tumors and Primary CNS Tumors, With or Without TRK, ROS1, or ALK Fusions



Status:Recruiting
Conditions:Cancer, Brain Cancer, Brain Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:2 - 22
Updated:3/27/2019
Start Date:May 3, 2016
End Date:June 1, 2023
Contact:Reference Study ID Number: CO40778 www.roche.com/about_roche/roche_worldwide.htm
Email:global-roche-genentech-trials@gene.com
Phone:888-662-6728 (U.S. and Canada)

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A Phase 1/1 b, Open-Label, Dose-Escalation and Expansion Study of Entrectinib (RXDX-101) in Children and Adolescents With Recurrent or Refractory Solid Tumors and Primary CNS Tumors, With or Without TRK, ROS 1, or ALK Fusions

This is a 5-part, open-label, Phase 1/1b multicenter, dose escalation study in pediatric
patients with relapsed refractory solid tumors; 2) primary CNS tumors; 3) neuroblastoma; 4)
non-neuroblastoma, extracranial solid tumors with NTRK1/2/3, ROS1 or ALK gene rearrangements;
and 5) patients who are otherwise eligible but unable to swallow capsules. The study is
designed to explore the safety, maximum tolerated dose (MTD) or recommended Phase 2 dose
(RP2D), pharmacokinetics, and antitumor activity of entrectinib.


Inclusion Criteria:

1. Ability to swallow capsules unless enrolled in Part E

2. Body surface area (BSA): Subjects must have a body surface area ≥ 0.45 m2 at the time
of the study enrollment, unless enrolled in Part E

3. Disease status: Subjects must have measurable or evaluable disease, by RECIST v1.1 ±
Curie Scale Criteria or RANO/RANO-BM

4. Tumor type:

- Part A: Relapsed or refractory extracranial solid tumors and (Phase 1b expansion)
relapsed or refractory extracranial solid tumors with molecular alterations,
non-gene fusions;

- Part B: Relapsed or refractory primary CNS tumors with molecular alterations,
including gene fusions, documented by a CLIA-approved lab prior to enrollment;

- Part C: Relapsed or refractory neuroblastoma;

- Part D: Relapsed or refractory non-neuroblastoma, extracranial solid tumors with
NTRK1/2/3, ROS1, or ALK gene fusions documented by a CLIA-approved lab prior to
enrollment;

- Part E: Any patient unable to swallow capsules who otherwise meet all other
eligibility criteria for Part A (expansion) B, C or D

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

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

7. Age: Male or female age ≥ 2 years and < 22 years unless enrolled in Part E

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

9. Patient's cancer must have relapsed after or failed to respond to frontline curative
therapy or there must not be other potentially curative treatment options available

10. Adequate organ and neurologic function

11. Females of child bearing potential must have a negative serum pregnancy test within 14
days prior to entrectinib dosing

Exclusion Criteria:

1. Receiving other experimental therapy

2. Known congenital long QT syndrome

3. Known active infections

4. Receiving Enzyme Inducing Antiepileptic Drugs (EIAEDs) within 14 days of first dose.

5. Incomplete recovery from acute effects of any surgery prior to treatment.

6. Active gastrointestinal disease or other malabsorption syndromes that would impact
drug absorption.

7. 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.
We found this trial at
21
sites
1201 W La Veta Ave
Orange, California 92868
(714) 997-3000
Principal Investigator: Elyssa Rubin, MD
Phone: 714-509-7868
Children's Hospital of Orange County For more than 45 years, CHOC Children’s has been steadfastly...
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3400 N Charles St
Baltimore, Maryland 21205
410-516-8000
Johns Hopkins University The Johns Hopkins University opened in 1876, with the inauguration of its...
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Baltimore, MD
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3333 Burnet Avenue # Mlc3008
Cincinnati, Ohio 45229
 1-513-636-4200 
Cincinnati Children's Hospital Medical Center Patients and families from across the region and around the...
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Cincinnati, OH
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262 Danny Thomas Pl
Memphis, Tennessee 38105
(901) 495-3300
Principal Investigator: Amar Gajjar, MD
Phone: 901-595-5787
St. Jude Children's Research Hospital St. Jude is unlike any other pediatric treatment and research...
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Memphis, TN
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South 34th Street
Philadelphia, Pennsylvania 19104
 215-590-1000
Principal Investigator: Elizabeth Fox, MD
Phone: 267-426-9293
Children's Hospital of Philadelphia Since its start in 1855 as the nation's first hospital devoted...
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Atlanta, GA
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Aurora, CO
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450 Brookline Ave
Boston, Massachusetts 2215
617-632-3000
Principal Investigator: Suzanne Shusterman, MD
Phone: 617-632-4931
Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
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Boston, MA
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Chicago, IL
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Columbus, OH
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801 7th Avenue
Fort Worth, Texas 76104
(682) 885-4000
Cook Children's Medical Center Cook Children's Health Care System is a not-for-profit, nationally recognized pediatric...
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Houston, TX
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3181 Southwest Sam Jackson Park Road
Portland, Oregon 97239
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Salt Lake City, Utah 84143
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San Diego, California 92123
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Washington, District of Columbia 20037
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