MEN1611 With Cetuximab in Metastatic Colorectal Cancer (C-PRECISE-01)
Completed · Phase 1/Phase 2
Conditions studied: Metastatic Colorectal Cancer
In brief
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.
Key facts
- Study ID
- NCT04495621
- Run by
- Menarini Group
- People needed
- 29
- Starts
- 2020-07-20
- Expected to finish
- 2024-02-27
- Last updated by the study team
- 2025-05-01
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Mayo Clinic Arizona — Phoenix, Arizona, United States
- The Oncology Institute of Hope and Innovation — Anaheim, California, United States
- MultiCare Health System Institute for Research and Innovation — Tacoma, Washington, United States
- ICO - Site Paul Papin — Angers, France
- Centre Georges François Leclerc — Dijon, France
- ICO - Site René Gauducheau — Saint-Herblain, France
- Charite Universitaetsmedizin Berlin - Campus Benjamin Franklin — Berlin, Germany
- Universitaetsklinikum Carl Gustav Carus TU Dresden — Dresden, Germany
- Asklepios Klinik Altona — Hamburg, Germany
- Klinikum der Universitaet Muenchen Campus Grosshadern — Munich, Germany
- Klinikum rechts der Isar der TU — Munich, Germany
- Universitaetsklinikum Tuebingen — Tübingen, Germany
- Azienda Ospedaliero Universitaria San Martino — Genoa, Italy
- Istituto Europeo di Oncologia (IEO) — Milan, Italy
- Azienda Socio Sanitaria Territoriale Niguarda — Milan, Italy
- Azienda Ospedaliero Universitaria Pisana — Pisa, Italy
- Istituto Clinico Humanitas — Rozzano, Italy
- Amsterdam University Medical Center — Amsterdam, Netherlands
- Maastricht University Medical Center — Maastricht, Netherlands
- Radboud Nijmegen — Nijmegen, Netherlands
- Erasmus Medisch Centrum — Rotterdam, Netherlands
- Examen sp. z o.o. — Skórzewo, Poland
- Centrum Onkologii-Instytut im.M.Sklodowskiej Curie — Warsaw, Poland
- Hospital Universitari Vall d'Hebron — Barcelona, Spain
- Hospital Universitario Ramon y Cajal — Madrid, Spain
Full record on ClinicalTrials.gov
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