A Study of Pralsetinib Versus Standard of Care (SOC) for Treatment of RET-Mutated Medullary Thyroid Cancer (MTC).

Sponsor
Hoffmann-La Roche
Study ID
NCT04760288
Phase
PHASE3
Status
Withdrawn

Conditions

  • Medullary Thyroid Cancer

Eligibility Criteria

Sex
ALL
Age
12 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Pralsetinib — DRUG
    Participants will receive pralsetinib at a dose of 400 mg, as per the dosing schedule described above.
  • Cabozantinib — DRUG
    Adult participants will receive cabozantinib at a dose of 140 mg, as per the dosing schedule described above.
  • Vandetanib — DRUG
    Adult participants will receive vandetanib at a dose of 300 mg and adolescent participants will receive vandetanib as per the dosing schedule described above.

Study Details

A study to evaluate the efficacy and safety of pralsetinib compared with SOC treatment (cabozantinib or vandetanib) for participants with RET (rearranged during transfection)-mutant MTC who have not previously received a SOC MultiKinase Inhibitor (MKI) therapy. Participants will be randomized in a 1:1 ratio into one of two treatment arms: Arm A (pralsetinib) or Arm B (investigator's choice of either cabozantinib or vandetanib for adults and vandetanib for adolescents). Participants whose disease progresses during SOC treatment will be offered the option to cross over to receive pralsetinib after confirmation of progressive disease by blinded independent central review (BICR).

Key Dates

Start date
Nov 30, 2023
Status verified
Jan 2024
Primary completion
Oct 6, 2027
Completion
Apr 12, 2035

Study Design

Enrollment
0 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm A (Pralsetinib)
    Participants will receive pralsetinib at a dose of 400 milligrams (mg) orally once daily (PO QD) in 28-day cycles.
  • Active Comparator: Arm B (SOC: Cabozantinib/Vandetanib)
    Adult participants will receive investigator's choice of SOC MKI therapy with either 140 mg cabozantinib PO QD or 300 mg vandetanib PO QD in 28-day cycles. Adolescents participants (≥ 12 and \< 18 years of age) will receive vandetanib, PO QD or every other day, in 28-day cycles depending on the body surface area (BSA), at a dose determined according to the dosing nomogram available in the E.U. Vandetanib SmPC.

Primary Outcome Measure

Progression-Free Survival (PFS) [ Time Frame: Up to 5 years ]

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