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Clinical Trial 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).


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT04760288
Study type Interventional
Source Hoffmann-La Roche
Contact
Status Withdrawn
Phase Phase 3
Start date November 30, 2023
Completion date April 12, 2035

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