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NCT03295396 · MORE INFO

Limitations, agreements, and source contact

ONC201 in Adults With Recurrent H3 K27M-mutant Glioma · Source last updated 2025-07-28

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

certain Agreement
other Details
Within 12 months of the completion of the Study at all sites, if no publication of the overall multi-center results has been made, institutions are entitled to publish their locally obtained results, provided the Sponsor is given the opportunity to review and comment. Institution publications may be delayed up to an additional 90 days to allow the Sponsor to seek patent protection.
pi Sponsor Employee
false
restriction Type
OTHER
restrictive Agreement
true
limitations And Caveats
description
The Sponsor terminated this study based on the initiation of a randomized Phase 3 study of dordaviprone (ONC201) in an earlier setting; closing this study ensured enrollment would not compete with the Phase 3 study. The decision was not related to any safety concerns with dordaviprone (ONC201). At the time enrollment was halted, some treatment arms had not completed enrollment. Note: This study did not assess response using RANO 2.0, as these criteria were established after study initiation.
point Of Contact
email
clinicaltrials@chimerix.com
organization
Chimerix, Inc.
phone
919-806-1074
phone Ext
101
title
Chief Medical Officer
Complete source fields
certain Agreement
other Details
Within 12 months of the completion of the Study at all sites, if no publication of the overall multi-center results has been made, institutions are entitled to publish their locally obtained results, provided the Sponsor is given the opportunity to review and comment. Institution publications may be delayed up to an additional 90 days to allow the Sponsor to seek patent protection.
pi Sponsor Employee
false
restriction Type
OTHER
restrictive Agreement
true
limitations And Caveats
description
The Sponsor terminated this study based on the initiation of a randomized Phase 3 study of dordaviprone (ONC201) in an earlier setting; closing this study ensured enrollment would not compete with the Phase 3 study. The decision was not related to any safety concerns with dordaviprone (ONC201). At the time enrollment was halted, some treatment arms had not completed enrollment. Note: This study did not assess response using RANO 2.0, as these criteria were established after study initiation.
point Of Contact
email
clinicaltrials@chimerix.com
organization
Chimerix, Inc.
phone
919-806-1074
phone Ext
101
title
Chief Medical Officer

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Preserved source evidence · Not medical advice