MEN1611 With Cetuximab in Metastatic Colorectal Cancer (C-PRECISE-01) (C-PRECISE-01)

January 19, 2024 updated by: Menarini Group

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

Open-label, dose-confirmation and cohort expansion, multicentre, Phase Ib/II study to assess the anti-tumour activity and safety of MEN1611 in combination with cetuximab for the treatment of patients with PIK3CA mutated metastatic colorectal cancer.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

This Phase Ib/II study will investigate the anti-tumour activity and safety of daily oral doses MEN1611 in combination with cetuximab in female and male patients affected by PIK3CA mutated, N-K-RAS wild-type and BRAF wild-type metastatic colorectal cancer.

MEN1611 is a potent, selective Class I phosphoinositide 3-kinase (PI3K) inhibitor. The Maximum Tolerated Dose (MTD) of MEN1611 given as single agent was assessed in a phase I trial in patients with advanced solid tumors.

This Phase Ib/II will start with a dose confirmation part (Step 1) to identify the RP2D of MEN1611 given in combination with cetuximab.

The study will continue with a cohort expansion (Step 2) to explore the anti-tumour activity of the selected MEN1611 dose level combined with cetuximab with further assessment of their safety and tolerability.

Study Type

Interventional

Enrollment (Actual)

29

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Angers, France, 49055
        • ICO - Site Paul Papin
      • Dijon, France, 21000
        • Centre Georges Francois Leclerc
      • Saint-Herblain, France, 44800
        • ICO - Site René Gauducheau
  • Germany
      • Berlin, Germany, 12203
        • Charite Universitaetsmedizin Berlin - Campus Benjamin Franklin
      • Dresden, Germany, 01307
        • Universitaetsklinikum Carl Gustav Carus TU Dresden
      • Munich, Germany, 81377
        • Klinikum der Universitaet Muenchen Campus Grosshadern
      • Munich, Germany, 81675
        • Munich
      • Tuebingen, Germany, 72076
        • Universitaetsklinikum Tuebingen
  • Italy
      • Genoa, Italy, 16132
        • Azienda Ospedaliero Universitaria San Martino
      • Milan, Italy, 20141
        • Istituto Europeo di Oncologia (IEO)
      • Milan, Italy, 20162
        • Azienda Socio Sanitaria Territoriale Niguarda
      • Pisa, Italy, 56126
        • Azienda Ospedaliero Universitaria Pisana
      • Rozzano, Italy, 20089
        • Istituto Clinico Humanitas
  • Netherlands
      • Amsterdam, Netherlands, 1105 AZ
        • Amsterdam University Medical Center
      • Maastricht, Netherlands, 6229 HX
        • Maastricht University Medical Center
      • Nijmegen, Netherlands, 6525 GA
        • Radboud Nijmegen
      • Rotterdam, Netherlands, 3015 GD
        • Erasmus Medisch Centrum
  • Poland
      • Skórzewo, Poland, 60-185
        • Examen sp. z o.o.
      • Warsaw, Poland, 00-001
        • Centrum Onkologii-Instytut im.M.Sklodowskiej Curie
  • Spain
      • Barcelona, Spain, 08035
        • Hospital Universitari Vall d'Hebron
      • Madrid, Spain, 28040
        • Fundacion Jimenez Diaz
      • Madrid, Spain, 28034
        • Hospital Universitario Ramon Y Cajal
      • Madrid, Spain, 28050
        • Centro Integral Oncologico Clara Campal
      • Valencia, Spain, 46010
        • Hospital Clinico Universitario de Valencia
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85054
        • Mayo Clinic Arizona
    • California
      • Anaheim, California, United States, 92801
        • The Oncology Institute of Hope and Innovation
    • Washington
      • Tacoma, Washington, United States, 98405
        • MultiCare Health System Institute for Research and Innovation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Main Inclusion Criteria:

  • Histological documentation of adenocarcinoma of the colon or rectum.
  • Progression or recurrence following prior irinotecan, oxaliplatin, 5-FU and anti-EGFR containing regimens for metastatic disease.
  • Best response according to Response Evaluation Criteria in Solid Tumours 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 (ECOG) performance status (PS) of 0 or 1.

Main Exclusion Criteria:

  • Previous treatment with PI3K inhibitor.
  • Brain metastases, unless treated > 4 weeks before Screening Visit and only if clinically stable and not receiving corticosteroids.
  • NCI CTCAE v5.0 Grade ≥ 2 diarrhoea.
  • History of significant, uncontrolled or active cardiovascular disease.
  • Known active or uncontrolled pulmonary dysfunction.
  • Uncontrolled diabetes mellitus (HbA1c > 7%) and fasting plasma glucose > 126 mg/dL.
  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: MEN1611
MEN1611 + Cetuximab
Drug: MEN1611
MEN1611 oral dose administered twice daily for a continuous 28-day cycle.
Drug: Cetuximab
Cetuximab solution for infusion administered weekly via IV infusion.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Determination of recommended phase II dose (RP2D)
Time Frame: 28 Days
Determination of the recommended phase II dose of MEN1611 when administered orally in combination with cetuximab to patients with PIK3CA mutated colorectal cancer failing irinotecan, oxaliplatin, 5-FU and anti-EGFR containing regimens.
28 Days
Best overall response rate (ORR) according to RECIST v.1.1
Time Frame: 36 Months
Assessment of the anti-tumour activity of MEN1611 in combination with cetuximab in patients with PIK3CA mutated metastatic colorectal cancer failing irinotecan, oxaliplatin, 5-FU and anti-EGFR containing regimens.
36 Months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of treatment emergent adverse events (TEAEs)
Time Frame: 36 Months
Assessment of the tolerability of MEN1611 in combination with cetuximab according to NCI CTCAE v5.0.
36 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Menarini Group

Investigators

  • Study Chair: Josep Tabernero, MD PhD, Vall d' Hebron Institute of Oncology (VHIO), Barcelona, Spain

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 20, 2020

Primary Completion (Estimated)

June 1, 2024

Study Completion (Estimated)

June 1, 2024

Study Registration Dates

First Submitted

June 30, 2020

First Submitted That Met QC Criteria

July 28, 2020

First Posted (Actual)

August 3, 2020

Study Record Updates

Last Update Posted (Actual)

January 22, 2024

Last Update Submitted That Met QC Criteria

January 19, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MEN1611-02
  • 2019-003727-38 (EudraCT Number)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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