TriangleNCT03258554 · 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
- pi Sponsor Employee
- false
- restriction Type
- LTE60
- restrictive Agreement
- true
- limitations And Caveats
- description
- Phase II (phII) component stopped enrollment early due to toxicity and futility concerns, with 186 of the 234 planned participants, but continued to collect data required for the final phII analysis. Per the protocol, the study did not continue to phase III (phIII). Therefore, the phIII primary outcome measure (OM) of overall survival was analyzed as a phII secondary OM. Accordingly, the phIII PD-L1 and p16 analyses were analyzed using the phII primary OM of progression-free survival.
- point Of Contact
- seiferheldw@nrgoncology.org
- organization
- NRG Oncology
- phone
- 2155743208
- title
- Wendy Seiferheld
Complete source fields
- certain Agreement
- pi Sponsor Employee
- false
- restriction Type
- LTE60
- restrictive Agreement
- true
- limitations And Caveats
- description
- Phase II (phII) component stopped enrollment early due to toxicity and futility concerns, with 186 of the 234 planned participants, but continued to collect data required for the final phII analysis. Per the protocol, the study did not continue to phase III (phIII). Therefore, the phIII primary outcome measure (OM) of overall survival was analyzed as a phII secondary OM. Accordingly, the phIII PD-L1 and p16 analyses were analyzed using the phII primary OM of progression-free survival.
- point Of Contact
- seiferheldw@nrgoncology.org
- organization
- NRG Oncology
- phone
- 2155743208
- title
- Wendy Seiferheld
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice