TriangleNCT03000452 · MORE INFO
Limitations, agreements, and source contact
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- certain Agreement
- other Details
- Results from a center cannot be submitted for publication before results of multicenter study are published unless it is \> 1 year since study completion. Then, Investigator can publish if manuscript is submitted to Celgene 60 days prior to submission. If Celgene decides publication would hinder drug development, Investigator must delay submission for up to 90 additional days. Investigator must delete confidential information before submission and defer publication to permit patent applications.
- pi Sponsor Employee
- false
- restriction Type
- OTHER
- restrictive Agreement
- true
- limitations And Caveats
- description
- An independent DMC reviewed data from Part 1 Stage 1 of the study on 26 Oct 2017; based on their recommendations, Celgene decided to close the study due to unfavorable efficacy results (number of responses to move to Stage 2 was not reached).
- point Of Contact
- ClinicalTrialDisclosure@Celgene.com
- organization
- Celgene Corporation
- phone
- 888-260-1599
- title
- Anne McClain, Senior Manager, Clinical Trial Disclosure
Complete source fields
- certain Agreement
- other Details
- Results from a center cannot be submitted for publication before results of multicenter study are published unless it is \> 1 year since study completion. Then, Investigator can publish if manuscript is submitted to Celgene 60 days prior to submission. If Celgene decides publication would hinder drug development, Investigator must delay submission for up to 90 additional days. Investigator must delete confidential information before submission and defer publication to permit patent applications.
- pi Sponsor Employee
- false
- restriction Type
- OTHER
- restrictive Agreement
- true
- limitations And Caveats
- description
- An independent DMC reviewed data from Part 1 Stage 1 of the study on 26 Oct 2017; based on their recommendations, Celgene decided to close the study due to unfavorable efficacy results (number of responses to move to Stage 2 was not reached).
- point Of Contact
- ClinicalTrialDisclosure@Celgene.com
- organization
- Celgene Corporation
- phone
- 888-260-1599
- title
- Anne McClain, Senior Manager, Clinical Trial Disclosure
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice