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This study evaluated the drug MEN1611 combined with Cetuximab in patients with metastatic colorectal cancer. Patients who had progressed after prior irinotecan, oxaliplatin, 5-FU and anti-EGFR regimens and had RAS/BRAF wild-type, PIK3CA-mutated tumors were eligible. The study was conducted in Phase 1/Phase 2 and has been completed.
The summary above is a plain-language rendering of the official record. The original English title is shown for reference.
Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.
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.