A Study of Pralsetinib Versus Standard of Care (SOC) for Treatment of RET-Mutated Medullary Thyroid Cancer (MTC). (AcceleRET-MTC)
A Study of Pralsetinib Versus Standard of Care (SOC) for Treatment of RET-Mutated Medullary Thyroid Cancer (MTC). (AcceleRET-MTC)
Brief 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). 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).
Study Type: Interventional (Clinical Trial)
Estimated Enrollment: 198 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase III, Randomized, Open-Label Study of Pralsetinib Versus Standard of Care for Treatment of RET-Mutated Medullary Thyroid Cancer.
Estimated Study Start Date: September 1, 2021
Estimated Primary Completion Date: April 15, 2026
Estimated Study Completion Date: April 15, 2028
Arm:
- Experimental: Arm A (Pralsetinib)
- Active Comparator: Arm B (SOC: Cabozantinib/Vandetanib)
| Category | Value |
|---|---|
| Study type(s) | Interventional |
| Estimated enrolment | 198 |
| Estimated Study start date | 01 September 2021 |
| Estimated Study Completion Date | 15 April 2028 |