MEN1611 With Cetuximab in Metastatic Colorectal Cancer (C-PRECISE-01)
NCT ID: NCT04495621
Last Updated: 2025-05-01
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1/PHASE2
29 participants
INTERVENTIONAL
2020-07-20
2024-02-27
Brief Summary
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Detailed Description
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MEN1611 is a potent, selective class I phosphoinositide 3-kinase (PI3K) inhibitor. The maximum tolerated dose of MEN1611 given as single agent was assessed in a Phase I trial in participants with advanced solid tumors.
This Phase Ib/II started with a dose confirmation part (Step 1) to identify the recommended phase 2 dose of MEN1611 given in combination with cetuximab.
The study continued with a cohort expansion (Step 2) to explore the anti-tumor activity of the selected MEN1611 dose level combined with cetuximab with further assessment of safety and tolerability.
Conditions
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Study Design
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NA
SEQUENTIAL
TREATMENT
NONE
Study Groups
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MEN1611
MEN1611 + Cetuximab
MEN1611
MEN1611 oral dose administered twice daily for a continuous 28-day cycle.
Cetuximab
Cetuximab solution for infusion administered weekly via intravenous infusion.
Interventions
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MEN1611
MEN1611 oral dose administered twice daily for a continuous 28-day cycle.
Cetuximab
Cetuximab solution for infusion administered weekly via intravenous infusion.
Eligibility Criteria
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Inclusion Criteria
* Progression or recurrence following prior irinotecan, oxaliplatin, 5-fluorouracil (5-FU) and anti-epidermal growth factor receptor (EGFR) containing regimens for metastatic disease.
* Best response according to Response Evaluation Criteria in Solid Tumours (RECIST) criteria to the last anti-EGFR containing regimen of partial response or stable disease for at least 4 months.
* Measurable disease according to RECIST criteria.
* N-K-RAS (exons 2, 3 and 4) and BRAF wild-type and PIK3CA mutated.
* Eastern Cooperative Oncology Group performance status of 0 or 1.
Exclusion Criteria
* Brain metastases, unless treated \>4 weeks before screening visit and only if clinically stable and not receiving corticosteroids.
* National Cancer Institute Common Terminology Criteria for Adverse Events v5.0 Grade ≥2 diarrhea.
* History of significant, uncontrolled or active cardiovascular disease.
* Known active or uncontrolled pulmonary dysfunction.
* Uncontrolled diabetes mellitus (glycated hemoglobin \>7%) and fasting plasma glucose \>126 milligrams/deciliter.
* Known history of human immunodeficiency virus infection or active infection with hepatitis C virus or hepatitis B virus.
* Concurrent chronic immunosuppressive treatment either with steroids or other immunosuppressive agents.
18 Years
ALL
No
Sponsors
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Menarini Group
INDUSTRY
Responsible Party
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Principal Investigators
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Josep Tabernero, MD, PhD
Role: STUDY_CHAIR
Vall d' Hebron Institute of Oncology (VHIO), Barcelona, Spain
Locations
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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
Fundacion Jimenez Diaz
Madrid, , Spain
Centro Integral Oncologico Clara Campal
Madrid, , Spain
Hospital Clinico Universitario de Valencia
Valencia, , Spain
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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MEN1611-02
Identifier Type: -
Identifier Source: org_study_id
2019-003727-38
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
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