The main objective of this trial is to evaluate the safety and tolerability of sotorasib combined with first-line chemotherapy for advanced pancreatic adenocarcinoma harboring KRAS p.G12C mutation.
Female of childbearing potential using a highly effective method of contraception (i.e., a method with less than 1% failure rate [e.g., sterilization, hormone implants, hormone injections, some intrauterine devices, or vasectomized partner])
Absolute neutrophil count (ANC) ≥ 1.5 x 109/L (without granulocyte colony-stimulating factor support within 2 weeks of laboratory test used to determine eligibility)
Hemoglobin ≥ 9.0 g/dL (without transfusion within 2 weeks of laboratory test used to determine eligibility)
Platelet count ≥ 100 x 109/L (without transfusion within 2 weeks of laboratory test used to determine eligibility)
Patients with resectable or borderline resectable pancreatic cancer.
Known history or positive viral test for human immunodeficiency virus (HIV).
Peripheral sensory neuropathy. 4 )Proven complete dihydropyrimidine dehydrogenase (DPD) deficiency for patients that will be treated with mFOLFIRINOX.
Active hepatitis B virus (HBV) is defined by a known positive HBV surface antigen (HBsAg) result. Patients with a past or resolved HBV infection (defined as the presence of hepatitis B core antibody and absence of HBsAg) are eligible
Single group
Sotorasib, 960 mg, oral daily dose for 4 weeks (28 days)
DrugA minimum of 6 and a maximum of 15 patients will be enrolled to receive first-line chemotherapy (gem/nab-P or mFOLFIRINOX at investigator choice) in combination with sotorasib 960 mg daily (QD). The treatment with gem/nab-P and mFOLFIRINOX should be managed as per clinical practice.
To evaluate the safety and tolerability of sotorasib combined with first-line chemotherapy for locally advanced or metastatic pancreatic adenocarcinoma harboring KRAS p.G12C mutation.
Incidence of treatment-emergent adverse events (TEAEs) and related TEAEs (TRAEs) according to CTCAE V5.0.
To evaluate the progression-free survival assessed by CT or MRI using RECIST 1.1 criteria of first-line chemotherapy combined with sotorasib for advanced pancreatic adenocarcinoma harboring KRAS p.G12C mutation
Progression-Free Survival (PFS) is defined as time from the first day of the study treatment (Day 1) until disease progression or death from any cause, whichever occurs first, for all patients, according to the investigator criteria.
To evaluate the overall survival of first-line chemotherapy combined with sotorasib for advanced pancreatic adenocarcinoma harboring KRAS p.G12C mutation.
The overall survival (OS) is defined as time from Day 1 until death from any cause.
Overall response (OR)
The overall response (OR) is defined as the best overall response complete response (CR) or partial response (PR), assessed per RECIST 1.1.
Disease control (DC)
The disease control (DC) is defined as the best overall response of CR or PR or of stable disease.
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Spanish Cooperative Group for the Treatment of Digestive Tumours (TTD)
Lead sponsor
Apices Soluciones S.L.
Collaborator
GERCOR - Multidisciplinary Oncology Cooperative Group
Collaborator
