Study Of Entrectinib (Rxdx-101) in Children and Adolescents With Locally Advanced Or Metastatic Solid Or Primary CNS Tumours And/Or Who Have No Satisfactory Treatment Options

Official Title

A Phase 1/2, Open-Label, Dose-Escalation And Expansion Study Of Entrectinib (Rxdx-101) In Pediatrics With Locally Advanced Or Metastatic Solid Or Primary CNS Tumours And/Or Who Have No Satisfactory Treatment Options

Summary:

This is an open-label, Phase 1/2 multicentre dose escalation study in pediatric patients with relapsed or refractory extracranial solid tumours (Phase 1), with additional expansion cohorts (Phase 2) in patients with primary brain tumours harboring NTRK1/2/3 or ROS1 gene fusions, and extracranial solid tumours harboring NTRK1/2/3 or ROS1 gene fusions.

Trial Description

Primary Outcome:

  • Maximum Tolerated Dose (MTD)
  • Recommended Phase 2 Dose (RP2D) of F1 Formulation In Pediatric Participants Able To Swallow Intact Capsules
  • Recommended Phase 2 Dose (RP2D) of F06 Formulation In Pediatric Participants Able To Swallow Intact Capsules
  • Recommended Phase 2 Dose (RP2D) of F06 Formulation In Pediatric In Participants Dosed Via Feeding Tube (Nasogastric Tube Or Gastric Tube)
  • Recommended Phase 2 Dose (RP2D) Of Minitablets/F15 Formulation In Pediatric Participants Unable To Swallow Intact Capsules
  • Objective Response Rate (ORR)
Secondary Outcome:
  • Safety and Tolerability - AE, ECG and Labs assessed by NCI CTCAE v4.03
  • Maximum observed plasma drug concentration (Cmax) using F1 Formulation
  • Maximum observed plasma drug concentration (Cmax) using F06 Formulation given intact
  • Maximum observed plasma drug concentration (Cmax) using F06 Formulation administered via feeding tube
  • Maximum observed plasma drug concentration (Cmax) using minitablets/F15
  • Time to Cmax, by inspection (Tmax) using F1 Formulation
  • Time to Cmax, by inspection (Tmax) using F06 Formulation given intact
  • Time to Cmax, by inspection (Tmax) using F06 Formulation administered via feeding tube
  • Time to Cmax, by inspection (Tmax) using minitablets/F15
  • AUC at steady state (AUCss) using F1 Formulation
  • AUC at steady state (AUCss) using F06 Formulation given intact
  • AUC at steady state (AUCss) using F06 Formulation administered via feeding tube
  • AUC at steady state (AUCss) using minitablets/F15
  • Terminal half life (t½) using F1 Formulation
  • Terminal half life (t½) using F06 Formulation given intact
  • Terminal half life (t½) using F06 Formulation administered via feeding tube
  • Terminal half life (t½) using minitablets/F15
  • Area under the drug concentration by time curve (AUC) using F1 Formulation
  • Area under the drug concentration by time curve (AUC) using F06 Formulation given intact
  • Area under the drug concentration by time curve (AUC) using F06 Formulation administered via feeding tube
  • Area under the drug concentration by time curve (AUC) using minitablets/F15
  • Progression-free Survival (PFS)
  • Overall Survival (OS)
  • Duration of Response (DOR)
  • Time to response (TTR)
  • Clinical Benefit Rate (CBR)

View this trial on ClinicalTrials.gov

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Resources

Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society