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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

Status
Closed
Cancer Type
Neuroblastoma
Trial Phase
Phase I
Phase II
Eligibility
0 - 18 Years, Male and Female
Study Type
Treatment
NCT ID
NCT02650401
Protocol IDs
RXDX-101-03 (primary)
NCI-2016-00924
Study Sponsor
Hoffmann-La Roche

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.

Eligibility

  1. Disease status:
  2. Phase 1 portion (closed): Participants must have measurable or evaluable disease, as defined by RECIST v1.1
  3. Phase 2 portion:
  4. Part B: Participants must have measurable or evaluable disease, as defined by RANO
  5. Part C (closed): Participants must have measurable or evaluable disease, as defined by RECIST v1.1 ± Curie Scale
  6. Part D: Participants must have measurable or evaluable disease, as defined by RECIST v1.1
  7. Part E (closed): Participants must have measurable or evaluable disease, as defined by RECIST v1.1 ± Curie Scale or RANO
  8. Tumor type:
  9. Phase 1 portion: * Part A: Relapsed or refractory extracranial solid tumors
  10. Phase 2 portion
  11. 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
  12. 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
  13. Histologic/molecular diagnosis of malignancy at diagnosis or the time of relapse
  14. Archival tumor tissue from diagnosis or, preferably, at relapse
  15. Performance status: Lansky or Karnofsky score = 60% and minimum life expectancy of at least 4 weeks
  16. 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
  17. Participants must have recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to enrollment
  18. Adequate organ and neurologic function
  19. 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.
  20. 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

Treatment Sites in Georgia

Emory University Hospital - Atlanta


1364 Clifton Road NE
Atlanta, GA 30322
www.emoryhealthcare.org

**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.
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Advancing Cancer Care through Partnerships and Innovation

Georgia CORE is a statewide nonprofit that leverages partnerships and innovation to attract more clinical trials, increase research, and promote education and early detection to improve cancer care for Georgians in rural, urban, and suburban communities across the state.