Phase 2
Completed
- Conditions
- -
- Registration Number
- JPRN-jRCT2080222950
- Lead Sponsor
- -
- Brief Summary
The study did not meet its primary endpoint of OS with palbociclib + cetuximab treatment arm when compared with placebo + cetuximab treatment arm, although the estimated HR using stratified analysis showed a numerical trend in favor of palbociclib + cetuximab. The study did not meet secondary endpoint of PFS (investigator’s assessment). Overall, the combination of palbociclib + cetuximab was well tolerated and the safety findings were aligned with the safety profile of both palbociclib and cetuximab.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 125
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method