Back to resultsMEN1611 With Cetuximab in Metastatic Colorectal Cancer (C-PRECISE-01) (C-PRECISE-01)
Primary Purpose
Metastatic Colorectal Cancer
Status
Active
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
MEN1611
Cetuximab
Sponsored by
About this trial
This is an interventional treatment trial for Metastatic Colorectal Cancer focused on measuring Metastatic Colorectal Cancer, PI3K Inhibitor, PIK3CA mutated, MEN1611, Cetuximab, anti-EGFR, mCRC
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 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.
Sites / Locations
- Mayo Clinic Arizona
- The Oncology Institute of Hope and Innovation
- MultiCare Health System Institute for Research and Innovation
- ICO - Site Paul Papin
- Centre Georges François Leclerc
- ICO - Site René Gauducheau
- Charite Universitaetsmedizin Berlin - Campus Benjamin Franklin
- Universitaetsklinikum Carl Gustav Carus TU Dresden
- Klinikum der Universitaet Muenchen Campus Grosshadern
- Munich
- Universitaetsklinikum Tuebingen
- Azienda Ospedaliero Universitaria San Martino
- Istituto Europeo di Oncologia (IEO)
- Azienda Socio Sanitaria Territoriale Niguarda
- Azienda Ospedaliero Universitaria Pisana
- Istituto Clinico Humanitas
- Amsterdam University Medical Center
- Maastricht University Medical Center
- Radboud Nijmegen
- Erasmus Medisch Centrum
- Examen sp. z o.o.
- Centrum Onkologii-Instytut im.M.Sklodowskiej Curie
- Hospital Universitari Vall d'Hebron
- Hospital Universitario Ramon y Cajal
- Fundacion Jimenez Diaz
- Centro Integral Oncologico Clara Campal
- Hospital Clinico Universitario de Valencia
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
MEN1611
Arm Description
MEN1611 + Cetuximab
Outcomes
Primary Outcome Measures
Determination of recommended phase II dose (RP2D)
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.
Best overall response rate (ORR) according to RECIST v.1.1
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
Incidence of treatment emergent adverse events (TEAEs)
Assessment of the tolerability of MEN1611 in combination with cetuximab according to NCI CTCAE v5.0.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04495621
Brief Title
MEN1611 With Cetuximab in Metastatic Colorectal Cancer (C-PRECISE-01)
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
July 20, 2020 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Menarini Group
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Colorectal Cancer
Keywords
Metastatic Colorectal Cancer, PI3K Inhibitor, PIK3CA mutated, MEN1611, Cetuximab, anti-EGFR, mCRC
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Sequential Assignment
Model Description
Step 1: Confirmation of Dose for Cohort Expansion / Step 2: Cohort Expansion
Masking
None (Open Label)
Allocation
N/A
Enrollment
29 (Actual)
8. Arms, Groups, and Interventions
Arm Title
MEN1611
Arm Type
Experimental
Arm Description
MEN1611 + Cetuximab
Intervention Type
Drug
Intervention Name(s)
MEN1611
Intervention Description
MEN1611 oral dose administered twice daily for a continuous 28-day cycle.
Intervention Type
Drug
Intervention Name(s)
Cetuximab
Intervention Description
Cetuximab solution for infusion administered weekly via IV infusion.
Primary Outcome Measure Information:
Title
Determination of recommended phase II dose (RP2D)
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.
Time Frame
28 Days
Title
Best overall response rate (ORR) according to RECIST v.1.1
Description
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.
Time Frame
36 Months
Secondary Outcome Measure Information:
Title
Incidence of treatment emergent adverse events (TEAEs)
Description
Assessment of the tolerability of MEN1611 in combination with cetuximab according to NCI CTCAE v5.0.
Time Frame
36 Months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Josep Tabernero, MD PhD
Organizational Affiliation
Vall d' Hebron Institute of Oncology (VHIO), Barcelona, Spain
Official's Role
Study Chair
Facility Information:
Facility Name
Mayo Clinic Arizona
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85054
Country
United States
Facility Name
The Oncology Institute of Hope and Innovation
City
Anaheim
State/Province
California
ZIP/Postal Code
92801
Country
United States
Facility Name
MultiCare Health System Institute for Research and Innovation
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States
Facility Name
ICO - Site Paul Papin
City
Angers
ZIP/Postal Code
49055
Country
France
Facility Name
Centre Georges François Leclerc
City
Dijon
ZIP/Postal Code
21000
Country
France
Facility Name
ICO - Site René Gauducheau
City
Saint-Herblain
ZIP/Postal Code
44800
Country
France
Facility Name
Charite Universitaetsmedizin Berlin - Campus Benjamin Franklin
City
Berlin
ZIP/Postal Code
12203
Country
Germany
Facility Name
Universitaetsklinikum Carl Gustav Carus TU Dresden
City
Dresden
ZIP/Postal Code
01307
Country
Germany
Facility Name
Klinikum der Universitaet Muenchen Campus Grosshadern
City
Munich
ZIP/Postal Code
81377
Country
Germany
Facility Name
Munich
City
Munich
ZIP/Postal Code
81675
Country
Germany
Facility Name
Universitaetsklinikum Tuebingen
City
Tuebingen
ZIP/Postal Code
72076
Country
Germany
Facility Name
Azienda Ospedaliero Universitaria San Martino
City
Genoa
ZIP/Postal Code
16132
Country
Italy
Facility Name
Istituto Europeo di Oncologia (IEO)
City
Milan
ZIP/Postal Code
20141
Country
Italy
Facility Name
Azienda Socio Sanitaria Territoriale Niguarda
City
Milan
ZIP/Postal Code
20162
Country
Italy
Facility Name
Azienda Ospedaliero Universitaria Pisana
City
Pisa
ZIP/Postal Code
56126
Country
Italy
Facility Name
Istituto Clinico Humanitas
City
Rozzano
ZIP/Postal Code
20089
Country
Italy
Facility Name
Amsterdam University Medical Center
City
Amsterdam
ZIP/Postal Code
1105 AZ
Country
Netherlands
Facility Name
Maastricht University Medical Center
City
Maastricht
ZIP/Postal Code
6229 HX
Country
Netherlands
Facility Name
Radboud Nijmegen
City
Nijmegen
ZIP/Postal Code
6525 GA
Country
Netherlands
Facility Name
Erasmus Medisch Centrum
City
Rotterdam
ZIP/Postal Code
3015 GD
Country
Netherlands
Facility Name
Examen sp. z o.o.
City
Skórzewo
ZIP/Postal Code
60-185
Country
Poland
Facility Name
Centrum Onkologii-Instytut im.M.Sklodowskiej Curie
City
Warsaw
ZIP/Postal Code
00-001
Country
Poland
Facility Name
Hospital Universitari Vall d'Hebron
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Hospital Universitario Ramon y Cajal
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Facility Name
Fundacion Jimenez Diaz
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Centro Integral Oncologico Clara Campal
City
Madrid
ZIP/Postal Code
28050
Country
Spain
Facility Name
Hospital Clinico Universitario de Valencia
City
Valencia
ZIP/Postal Code
46010
Country
Spain
12. IPD Sharing Statement
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MEN1611 With Cetuximab in Metastatic Colorectal Cancer (C-PRECISE-01)
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