Status:
COMPLETED
MEN1611 With Cetuximab in Metastatic Colorectal Cancer (C-PRECISE-01)
Lead Sponsor:
Menarini Group
Conditions:
Metastatic Colorectal Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
Open-label, dose-confirmation and cohort expansion, multicenter, Phase Ib/II study to assess the anti-tumor activity and safety of MEN1611 in combination with cetuximab for the treatment of participan...
Detailed Description
This Phase Ib/II study investigated the anti-tumor activity and safety of daily oral doses MEN1611 in combination with cetuximab in female and male participants affected by PIK3CA-mutated, neuroblasto...
Eligibility Criteria
Inclusion
- Main
- Histological documentation of adenocarcinoma of the colon or rectum.
- Progression or recurrence following prior irinotecan, oxaliplatin, 5-fluorouracil (5-FU) and anti-epidermal growth factor receptor (EGFR) containing regimens for metastatic disease.
- Best response according to Response Evaluation Criteria in Solid Tumours (RECIST) 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 performance status of 0 or 1.
- Main
Exclusion
- Previous treatment with PI3K inhibitor.
- Brain metastases, unless treated \>4 weeks before screening visit and only if clinically stable and not receiving corticosteroids.
- National Cancer Institute Common Terminology Criteria for Adverse Events v5.0 Grade ≥2 diarrhea.
- History of significant, uncontrolled or active cardiovascular disease.
- Known active or uncontrolled pulmonary dysfunction.
- Uncontrolled diabetes mellitus (glycated hemoglobin \>7%) and fasting plasma glucose \>126 milligrams/deciliter.
- 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.
Key Trial Info
Start Date :
July 20 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 27 2024
Estimated Enrollment :
29 Patients enrolled
Trial Details
Trial ID
NCT04495621
Start Date
July 20 2020
End Date
February 27 2024
Last Update
May 1 2025
Active Locations (28)
Enter a location and click search to find clinical trials sorted by distance.
1
Mayo Clinic Arizona
Phoenix, Arizona, United States, 85054
2
The Oncology Institute of Hope and Innovation
Anaheim, California, United States, 92801
3
MultiCare Health System Institute for Research and Innovation
Tacoma, Washington, United States, 98405
4
ICO - Site Paul Papin
Angers, France, 49055