NCT04760288

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

A Phase III, Randomized, Open-Label Study of Pralsetinib Versus Standard of Care for Treatment of RET-Mutated Medullary Thyroid Cancer.

• Status: Withdrawn
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

Summary

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).

Conditions

• Medullary Thyroid Cancer

Interventions

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

Timeline

• Start date: 2023-11-30
• Primary completion: 2027-10-06
• Completion: 2035-04-12
• First posted: 2021-02-18
• Last updated: 2024-01-05

Locations

1 site across 1 country: Spain

Regulatory

• FDA-regulated drug study