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

  • STATUS
    Recruiting
  • End date
    Aug 30, 2029
  • participants needed
    68
  • sponsor
    Hoffmann-La Roche
Updated on 3 July 2021
Investigator
Cecilia Carlowicz
Primary Contact
Dana Farber Cancer Institute (4.5 mi away) Contact
+4 other location
cancer
serum pregnancy test
ROS1
brain tumor
solid tumour
cns tumor
entrectinib

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.

Details
Condition Central Nervous System Neoplasms, Neuroblastoma, Solid Tumors, Solid Neoplasm, Solid Tumour, cns tumors, cns tumor, cns neoplasm, central nervous system tumors, central nervous system tumor
Treatment Entrectinib
Clinical Study IdentifierNCT02650401
SponsorHoffmann-La Roche
Last Modified on3 July 2021

Eligibility

Yes No Not Sure

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
Clear my responses

How to participate?

Step 1 Connect with a site
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar
Name

Primary Contact

site
Name

0/250
Preferred Language
Other Language
Please verify that you are not a bot.

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note