A Study of Oral LOXO-292 (Selpercatinib) in Pediatric Participants With Advanced Solid or Primary Central Nervous System (CNS) Tumours

Titre officiel

A Phase 1/2 Study of the Oral RET Inhibitor LOXO 292 in Pediatric Patients With Advanced RET-Altered Solid or Primary Central Nervous System Tumours

Sommaire:

Il s’agit d’une étude ouverte de phase I/II multicentrique évaluant le LOXO-292 par voie orale chez des participants pédiatriques atteints d’une tumeur solide ou d’une tumeur primaire du système nerveux central (SNC) au stade avancé présentant une altération RET (réarrangement pendant la transfection) activatrice.

Description de l'essai

Primary Outcome:

  • To Determine the Safety of Oral LOXO-292 in Pediatric Participants with Advanced Solid Tumours: Dose Limiting Toxicities (DLTs)
  • To Determine the Safety of Oral LOXO-292 in Pediatric Participants with Primary CNS Tumours: DLTs
  • Overall Response Rate (ORR) Based on Response Evaluation Criteria in Solid Tumours (RECIST) 1.1 per Independent Review Committee (IRC)
  • ORR Based on Response Assessment in Neuro-Oncology (RANO) per IRC
Secondary Outcome:
  • Plasma Concentrations of LOXO-292
  • Area Under the Concentration-Time Curve from 0 to 24 hours (AUC0-24) of LOXO-292
  • Maximum Concentration (Cmax) of LOXO-292
  • Time to Maximum Concentration (Tmax) of LOXO-292
  • Recommended LOXO-292 Dose for Phase 2 (MTD)
  • To Assess the Preliminary Anti-Tumour Activity of LOXO-292 in Pediatric Participants with Tumours Harboring an Activating RET Alteration as Determined by ORR Based on RECIST v1.1
  • Changes from Baseline in Pain Measures as Measured by Wong Baker Faces scales. Wong-Baker Faces Pain Scale includes pictures of facial expressions with correlating scores of 0 being 'no hurt' and 10 being 'hurts worst'.
  • Changes from Baseline in Health Related Quality of Life Measures as Measured by Pediatric Quality of Life (PedsQoL) Inventory Core. PedsQoL includes a list of problems with scores of 0 being 'never a problem' and 4 being 'almost always a problem'.
  • Objective Response Rate as Assessed by RECIST v1.1, as Assessed by Investigator
  • Objective Response Rate as Assessed by RANO, as Assessed by Investigator
  • Duration of Response (DOR) as Assessed by Investigator
  • Duration of Response (DOR) as Assessed by the IRC
  • Progression Free Survival (PFS) as Assessed by Investigator
  • PFS as Assessed by IRC
  • Overall survival (OS)
  • Clinical Benefit Rate (by Investigator)
  • Clinical Benefit Rate (by IRC)
  • Frequency of Adverse Events (AEs)
  • To Evaluate the Concordance of Prior Molecular that Detected a RET Alteration within the Participant's Tumour with Diagnostic Tests Being Evaluated by Sponsor
  • Phase 2: Post-Operative Stage on Participants Treated with LOXO-292
  • Phase 2: Surgical Margin Status in Participants Treated with LOXO-292
  • Descriptive Analysis of Pretreatment Surgical Plan
  • Descriptive Analysis of Post-Treatment Plans
This study includes 2 parts: phase 1 (dose escalation) and phase 2 (dose expansion). In phase 1, participants will be enrolled using a rolling 6 dose escalation scheme. The starting dose of LOXO-292 is equivalent to the adult recommended phase 2 dose of 160 milligrams (mg) twice a day (BID). Once the maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D) is identified, participants will be enrolled to one of four phase 2 dose expansion cohorts depending on tumour histology and tumour genotype. Cycle length will be 28 days.

Voir cet essai sur ClinicalTrials.gov

Intéressé(e) par cet essai?

Imprimez cette page et apportez-la chez votre médecin pour discuter de votre admissibilité à cet essai et des options de traitement. Seul votre médecin peut vous recommander pour un essai clinique.

Ressources

Société canadienne du cancer

Ces ressources sont fournies en partenariat avec Société canadienne du cancer