Study Of Entrectinib (Rxdx-101) in Children and Adolescents With Locally Advanced Or Metastatic Sā¦ (NCT02650401) | Clinical Trial Compass
Active ā Not RecruitingPhase 1/2
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
United States69 participantsStarted 2016-05-03
Plain-language 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.
Who can participate
Age range0 Years ā 18 Years
SexALL
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Inclusion criteria
ā. Disease status:
ā. Tumor type:
ā. Histologic/molecular diagnosis of malignancy at diagnosis or the time of relapse
ā. Archival tumor tissue from diagnosis or, preferably, at relapse
ā. Performance status: Lansky or Karnofsky score ā„ 60% and minimum life expectancy of at least 4 weeks
ā. 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
ā. Participants must have recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to enrollment
ā. Adequate organ and neurologic function
Exclusion criteria
ā. Receiving other experimental therapy
ā. Known congenital long QT syndrome
ā. History of recent (3 months) symptomatic congestive heart failure or ejection fraction ā¤50% at screening
ā. Known active infections
ā
What they're measuring
1
Maximum Tolerated Dose (MTD)
Timeframe: Approximately 6 months
2
Recommended Phase 2 Dose (RP2D) of F1 Formulation In Pediatric Participants Able To Swallow Intact Capsules
Timeframe: Approximately 6 months
3
Recommended Phase 2 Dose (RP2D) of F06 Formulation In Pediatric Participants Able To Swallow Intact Capsules
Timeframe: Approximately 6 months
4
Recommended Phase 2 Dose (RP2D) of F06 Formulation In Pediatric In Participants Dosed Via Feeding Tube (Nasogastric Tube Or Gastric Tube)
Timeframe: Approximately 6 months
5
Recommended Phase 2 Dose (RP2D) Of Minitablets/F15 Formulation In Pediatric Participants Unable To Swallow Intact Capsules