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Trial record 1 of 1 for:    MEN1611-02
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MEN1611 With Cetuximab in Metastatic Colorectal Cancer (C-PRECISE-01) (C-PRECISE-01)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04495621
Recruitment Status : Recruiting
First Posted : August 3, 2020
Last Update Posted : December 7, 2020
Information provided by (Responsible Party):
Menarini Group

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Metastatic Colorectal Cancer Drug: MEN1611 Drug: Cetuximab Phase 1 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 42 participants
Intervention Model: Sequential Assignment
Intervention Model Description: Step 1: Confirmation of Dose for Cohort Expansion / Step 2: Cohort Expansion
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : July 20, 2020
Estimated Primary Completion Date : July 2023
Estimated Study Completion Date : July 2023

Resource links provided by the National Library of Medicine

Drug Information available for: Cetuximab

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.

Primary Outcome Measures :
  1. 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.

  2. 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.

Secondary Outcome Measures :
  1. 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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 at least stable disease for 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.
  • Previous treatment with an anti-EGFR containing regimen for metastatic disease within 6 months prior to inclusion into the study.
  • Untreated brain metastases, unless treated > 4 weeks earlier 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04495621

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Contact: Angela Capriati - Corporate Director, MD PhD +390555680 ext 9990
Contact: Ram Charan - Clinical Research Physician, MD PhD +390555680 ext 9990

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Sponsors and Collaborators
Menarini Group
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Study Chair: Josep Tabernero, MD PhD Vall d' Hebron Institute of Oncology (VHIO), Barcelona, Spain
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Responsible Party: Menarini Group Identifier: NCT04495621    
Other Study ID Numbers: MEN1611-02
2019-003727-38 ( EudraCT Number )
First Posted: August 3, 2020    Key Record Dates
Last Update Posted: December 7, 2020
Last Verified: December 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Menarini Group:
Metastatic Colorectal Cancer
PI3K Inhibitor
PIK3CA mutated
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Antineoplastic Agents, Immunological
Antineoplastic Agents