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.
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
Drug | Synonyms | Arms |
---|
MEN1611 | | MEN1611 |
Cetuximab | | MEN1611 |
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
Name | Type | Description | Interventions |
---|
MEN1611 | Experimental | 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: | Recruiting |
Lead Sponsor: | Menarini Group |
Trial Keywords
- Metastatic Colorectal Cancer
- PI3K Inhibitor
- PIK3CA mutated
- MEN1611
- Cetuximab
Last Updated
December 7, 2020