Phase 1/2 Study of LOXO-292 in Patients With Advanced Solid Tumours, RET Fusion-Positive Solid Tumours, and Medullary Thyroid Cancer

Titre officiel

A Phase 1/2 Study of Oral LOXO-292 in Patients With Advanced Solid Tumours, Including RET Fusion-Positive Solid Tumours, Medullary Thyroid Cancer, and Other Tumours With RET Activation (LIBRETTO-001)

Sommaire:

Il s’agit d’une étude de phase I/II ouverte, menée pour la première fois chez l’humain, conçue pour évaluer l’innocuité, la tolérabilité, les paramètres pharmacocinétiques et l’activité antitumorale préliminaire de LOXO-292 administré par voie orale à des patients atteints de tumeurs solides avancées, notamment de tumeurs solides positives à la fusion du gène RET, de cancer médullaire de la thyroïde (CMT) et d’autres tumeurs avec activation du gène RET.

Description de l'essai

Primary Outcome:

  • Phase 1: Maximum tolerated dose (MTD)
  • Phase 1: Recommended Phase 2 dose (RP2D)
  • Phase 2: Objective Response Rate
Secondary Outcome:
  • Phase 1: Frequency, severity, and relatedness of TEAEs and serious adverse events (SAEs), changes in hematology and blood chemistry values, assessments of physical examinations, vital signs, and electrocardiograms (ECGs).
  • Phase 1: Plasma concn of LOXO-292 (selpercatinib) and PK parameters, including but not limited to area under the curve from time 0 to 24 hrs (AUC0-24), max drug concn (Cmax), time to max plasma concn (Tmax), and degree of accumulation
  • Phase 1: ORR based on RECIST 1.1 or RANO, as appropriate to tumour type.
  • Phase 2: ORR (by Investigator)
  • Phase 2: best change in tumour size from baseline (by IRC and Investigator)
  • Phase 2: DOR (by IRC and Investigator)
  • Phase 2: CNS ORR (by IRC)
  • Phase 2: CNS DOR (by IRC)
  • Phase 2: time to any and best response (by IRC and Investigator)
  • Phase 2: CBR (by IRC and Investigator)
  • Phase 2: PFS (by IRC and Investigator)
  • Phase 2: OS
  • Phase 2: Frequency, severity and relatedness of TEAEs and SAEs, changes in hematology and blood chemistry values, assessments of physical examinations, vital signs and ECGs.
  • Phase 2: Plasma concentrations of LOXO-292 (selpercatinib) and PK parameters, including but not limited to AUC0-24, Cmax, and Tmax.
This is an open-label, multi-centre Phase 1/2 study in patients with advanced solid tumours, including RET fusion-positive solid tumours, MTC, and other tumours with RET activation. The trial will be conducted in 2 parts: phase 1 (dose escalation) and phase 2 (dose expansion). Patients with advanced cancer are eligible if they have progressed on or are intolerant to available standard therapies, or no standard or available curative therapy exists, or in the opinion of the Investigator, they would be unlikely to tolerate or derive significant clinical benefit from appropriate standard of care therapy, or they declined standard therapy. A dose of 160 mg BID has been selected as the recommended phase 2 dose (RP2D). Up to
  • 850 patients with advanced solid tumours harboring a RET gene alteration in tumour and/or blood will be enrolled to one of five phase 2 cohorts.
  • Voir cet essai sur ClinicalTrials.gov

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