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About
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.
Full description
This is a phase 2, multicenter and open-label study of first-line chemotherapy (gemcitabine combined with nab-paclitaxel [gem/nab-P] or modified FOLFIRINOX [mFOLFIRINOX]) in combination with sotorasib for patients with advance pancreatic cancer harboring KRAS p.G12C mutation.The study will be conducted at approximately 25 sites distributed in two countries (Spain and France). The study will consist of a screening period, a treatment period, a safety follow-up (SFU) and long-term follow-up (LTFU) period. A minimum of 6 and a maximum of 15 patients will be enrolled to receive first-line chemotherapy (gem/nab-P or mFOLFIRINOX) in combination with sotorasib 960 mg daily (QD). An interim safety analysis will be conducted by an independent data monitoring committee (DMC) DMC after the first 3 evaluable patients treated with sotorasib combined with gem/nab-P and an additional interim safety analysis with the first 3 evaluable patients treated with sotorasib combined with mFOLFIRINOX have been treated for at least 1 month, respectively. Patients may discontinue treatment because of disease progression, intolerance of treatment leading to treatment discontinuation, initiation of another anticancer therapy, or withdrawal of consent.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Willing and able to provide informed consent.
Men or women aged ≥ 18 years old.
Using adequate contraceptive measures or sexual abstinence during the treatment and for 7 additional days after the last dose of sotorasib and for at least 6 months afterwards after the last dose of mFOLFIRINOX or gem/nab-P
Pathologically confirmed treatment-naïve of advanced pancreatic adenocarcinoma harboring KRAS p.G12C mutation assessed by means of a IVDR compliant test).
Measurable disease per RECIST 1.1 criteria.
Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
Life expectancy > 3 months, in the opinion of the investigator.
Adequate hematologic, renal and hepatic organ function, defined as the following within 10 days prior study inclusion:
Ability to take oral medications and willing to record daily adherence to investigational product.
Exclusion criteria
Known history or positive viral test for human immunodeficiency virus (HIV).
Patients with known active hepatitis (i.e., Hepatitis B or C)
Female: currently pregnant or breast-feeding or who plan to breastfeed while on study though 7 additional days after the last dose of sotorasib and for at least 6 months afterwards after the last dose of FOLFIRINOX or gem/nab-P
Myocardial infarction within 6 months of study Day 1, symptomatic congestive heart failure (New York Heart Association > class II), unstable angina, or cardiac arrhythmia requiring medication
Prior anti-tumor treatment for metastatic or advanced pancreatic adenocarcinoma*. Prior chemotherapy or radiotherapy in the adjuvant or neoadjuvant setting is acceptable if received > 6 months prior to study enrolment
*If initiation of treatment is deemed urgent by the investigator, patients can receive 1st month of Standard of Care (SoC) gem/nab-P (1 cycle) or FOLFIRINOX (2 cycles) during screening. This first month of gem/nab-P or FOLFIRINOX is not a requirement of the study and is not part of this clinical study
Active infection requiring antibiotics within 1 weeks of study enrollment.
Other malignancy unless curatively treated with no evidence of disease for ≥2 years except: adequately treated non-melanoma skin cancer, curatively treated in situ cancer of the cervix, and/or ductal carcinoma in situ.
Significant gastrointestinal disorder that results in significant malabsorption, requirement for IV alimentation, or inability to take oral medication.
History of interstitial pneumonitis or pulmonary fibrosis or evidence of interstitial pneumonitis or pulmonary fibrosis.
Presence of any condition that, in the opinion of the investigator, renders the patient at high risk from treatment complications or might affect the interpretation of the results of the study.
Significant uncontrolled concomitant disease that could affect compliance with protocol procedures or interpretation of results or that pose a risk to patient safety, in the opinion of the investigator.
Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures at a frequency greater than monthly. Patients with PleurX catheters or intraperitoneal drainage catheters in place may be considered for the study with Medical Monitor approval.
Major surgery within 4 weeks of study Day 1
Prior/concomitant therapy:
Patient has known sensitivity to any of the products or components to be administered during the study.
History or evidence of any other clinically significant disorder, condition or disease (with the exception of those outlined above) that, in the opinion of the investigator would pose a risk to patient safety or interfere with the study evaluation, procedures, or completion.
Primary purpose
Allocation
Interventional model
Masking
15 participants in 1 patient group
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Central trial contact
Grupo de Tratamiento de los Tumores Digestivos
Data sourced from clinicaltrials.gov
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