Clinical Trials /

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

NCT04495621

Description:

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.

Related Conditions:
  • Colon Adenocarcinoma
  • Rectal Adenocarcinoma
Recruiting Status:

Recruiting

Phase:

Phase 1/Phase 2

Trial Eligibility

Document

Title

  • Brief Title: MEN1611 With Cetuximab in Metastatic Colorectal Cancer (C-PRECISE-01)
  • 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

Clinical Trial IDs

  • ORG STUDY ID: MEN1611-02
  • SECONDARY ID: 2019-003727-38
  • NCT ID: NCT04495621

Conditions

  • Metastatic Colorectal Cancer

Interventions

DrugSynonymsArms
MEN1611MEN1611
CetuximabMEN1611

Purpose

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.

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.
    

Trial Arms

NameTypeDescriptionInterventions
MEN1611ExperimentalMEN1611 + Cetuximab
  • MEN1611
  • Cetuximab

Eligibility Criteria

        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.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Determination of recommended phase II dose (RP2D)
Time Frame:28 Days
Safety Issue:
Description: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.

Secondary Outcome Measures

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

Details

Phase:Phase 1/Phase 2
Primary Purpose:Interventional
Overall Status:Not yet recruiting
Lead Sponsor:Menarini Group

Trial Keywords

  • Metastatic Colorectal Cancer
  • PI3K Inhibitor
  • PIK3CA mutated
  • MEN1611
  • Cetuximab

Last Updated

July 28, 2020