Study Investigating the Association of NP137 With mFOLFIRINOX in Locally Advanced Pancreatic Duct… (NCT05546853) | Clinical Trial Compass
CompletedPhase 1
Study Investigating the Association of NP137 With mFOLFIRINOX in Locally Advanced Pancreatic Ductal Adenocarcinoma
France43 participantsStarted 2023-03-28
Plain-language summary
The study will assess the safety of the association of NP137 with the standard of care mFOLFIRINOX in the treatment of locally advanced pancreatic ductal adenocarcinoma.The study drug which is tested is the NP137 in association with mFOLFIRINOX to allow a better tumor response as well as better survival outcomes with an acceptable safety.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Age from 18 to 79 years
✓. Able to understand and sign informed consent
✓. Histologically or cytologically proven diagnosis of pancreatic ductal adenocarcinoma
✓. Locally advanced pancreatic cancer considered unresectable according to NCCN Guidelines® Version 2.2021
✓. Measurable disease as defined by Response Evaluation Criteria in Solid Tumors RECIST 1.1 criteria
✓. Male, or non-pregnant and non-lactating female
✓. Women patients of childbearing potential\* must have a negative serum/urine pregnancy test at screening and baseline, and be willing to use a highly effective\*\* contraception. The patient should be advised to continue the contraception for at least 6 months following the completion of dosing. Women with cessation for \> 24 months of previously occurring menses, or women of any age who have had a hysterectomy, or have had both ovaries removed will be considered to be of non-childbearing potential
✓. Male patients of reproductive potential must be willing to use one acceptable method of contraception, as judged by Investigator and Sponsor and/or to refrain from donating sperm from the time of screening through at least 6 months following the completion of dose administration
Exclusion criteria
✕. Patients with resectable pancreatic cancer
✕. Evidence of the presence of metastases.
What they're measuring
1
Percentage Proportion of patients experiencing adverse events
. Patients who have received prior systemic therapy, radiation therapy, or resection for pancreatic cancer or prior therapy with NP137
✕. Patients with known Dihydropyrimidine dehydrogenase (DPD) deficiency, or homozygosity for UGT1A1\*28 polymorphism (UGT1A1 genotype analysis is not required to be eligible)
✕. Previous (within the past 3 years) or concurrent malignancy diagnosis except non-melanoma skin cancer and in situ carcinomas (excluding in situ breast cancer)
✕. History of severe (grade ≥ 3) allergic reactions to one of the components of chemotherapy, or NP137
✕. Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding that contraindicates the use of an investigational drug, may affect the interpretation of the results, may decrease subject's compliance to study's procedures or may render the patient at high risk from treatment complications in the opinion of the treating investigator
✕. Subjects with known poorly controlled comorbid conditions, including; congestive heart failure (CHF), chronic obstructive pulmonary disease (COPD), uncontrolled diabetes mellitus (DM) or neurologic disorders (not acutely related to pancreatic cancer) or limited function