At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 29 enrolled
Drug / intervention
MEN1611 +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Open-label, Multicentre, Phase Ib/II Study of MEN1611, a PI3K Inhibitor, and Cetuximab in Patients With PIK3CA Mutated Metastatic Colorectal Cancer Failing Irinotecan, Oxaliplatin, 5-FU and Anti-EGFR Containing Regimens
In Brief
A Phase 2 clinical trial evaluating MEN1611 and Cetuximab for Metastatic Colorectal Cancer. Completed, enrolled 29 participants across 28 sites in 7 countries.
Detailed Summary
Open-label, dose-confirmation and cohort expansion, multicenter, Phase Ib/II study to assess the anti-tumor activity and safety of MEN1611 in combination with cetuximab for the treatment of participants with phosphatidylinositol 3-kinase, catalytic, alpha polypeptide gene (PIK3CA)-mutated metastatic colorectal cancer.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMetastatic Colorectal Cancer
CountriesFrance, Germany, Italy, Netherlands, Poland, Spain, United States
Collaborators--
Timeline
Phase 2CompletedFinished
202120222023202420252026
Enrollment StartJul 2020
First PostedAug 2020
Primary CompletionJan 2024
Study CompletionFeb 2024
TodayJul 2026
First PostedAug 3, 2020
Enrollment StartJul 20, 2020
Primary CompletionJan 12, 2024
Study CompletionFeb 27, 2024
TodayJul 2, 2026
Enrollment to primary: 3.5 yearsPosted 5.9 years ago
Interventions
MEN1611drug
MEN1611 oral dose administered twice daily for a continuous 28-day cycle.
Cetuximabdrug
Cetuximab solution for infusion administered weekly via intravenous infusion.