TriangleNCT01849874 · 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
- Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- pi Sponsor Employee
- false
- restriction Type
- OTHER
- restrictive Agreement
- true
- limitations And Caveats
- description
- In the futility analysis based on PCD, the futility boundary was crossed, and therefore, no additional efficacy data was collected and no additional efficacy analyses were conducted. As of 01 Apr 2016, enrollment into the study were discontinued and crossover treatment was no longer permitted, any participants still receiving MEK162 were allowed to continue at the discretion of the investigator until any treatment discontinuation criterion was met and discontinued after 30-day safety follow up.
- point Of Contact
- ClinicalTrials.gov_Inquiries@pfizer.com
- organization
- Pfizer Inc.
- phone
- 1-800-718-1021
- title
- Pfizer ClinicalTrials.gov Call Center
Complete source fields
- certain Agreement
- other Details
- Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- pi Sponsor Employee
- false
- restriction Type
- OTHER
- restrictive Agreement
- true
- limitations And Caveats
- description
- In the futility analysis based on PCD, the futility boundary was crossed, and therefore, no additional efficacy data was collected and no additional efficacy analyses were conducted. As of 01 Apr 2016, enrollment into the study were discontinued and crossover treatment was no longer permitted, any participants still receiving MEK162 were allowed to continue at the discretion of the investigator until any treatment discontinuation criterion was met and discontinued after 30-day safety follow up.
- point Of Contact
- ClinicalTrials.gov_Inquiries@pfizer.com
- organization
- Pfizer Inc.
- phone
- 1-800-718-1021
- title
- Pfizer ClinicalTrials.gov Call Center
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice