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

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• Main Inclusion Criteria:
• 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 Criteria:
• 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.