Ignite Creation Date:
2024-05-06 @ 3:49 PM
Last Modification Date:
2024-10-26 @ 1:57 PM
Study NCT ID:
NCT04760288
Status:
WITHDRAWN
Last Update Posted:
2024-01-05
First Post:
2021-02-17
Brief Title:
A Study of Pralsetinib Versus Standard of Care SOC for Treatment of RET-Mutated Medullary Thyroid Cancer MTC
Sponsor:
Hoffmann-La Roche
Organization:
Hoffmann-La Roche
Study Overview
Official Title:
A Phase III Randomized Open-Label Study of Pralsetinib Versus Standard of Care for Treatment of RET-Mutated Medullary Thyroid Cancer
Status:
WITHDRAWN
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Due to several logistical challenges during start-up which could not be overcome study was withdrawn
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
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 11 ratio into one of two treatment arms Arm A pralsetinib or Arm B investigators 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2020-005269-15 | EUDRACT_NUMBER | None | None |