Status and phase
Conditions
Treatments
About
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.
Full description
The study is a multicentric, prospective, single arm phase 1b trial. This study will enroll 43 to 52 patients and consists of 2 parts: Safety Lead-in Phase and Expansion Phase. Initially, 3 to 12 patients will be enrolled into a Safety Lead-in Phase based on a 3 + 3 design, with the possibility of dose de-escalation, to confirm the recommended dose of NP137.The Expansion Phase will start after completion of Safety Lead-in Phase at the confirmed dose and will include 40 patients. Patients will be assigned to the experimental arm (NP137 + mFOLFIRINOX).
Enrollment
Sex
Ages
Volunteers
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
No prior systemic therapy, radiation therapy, or resection for pancreatic cancer
Life expectancy ≥ 12 weeks
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Adequate liver function:
Adequate bone marrow function: platelets >100,000 cells/mm3, hemoglobin > 9.0 g/dl and absolute neutrophil count (ANC) >1,500 cells/mm3
Adequate renal function: creatinine < 1.5 x ULN, creatinine clearance ≥ 30 mL/min/m2
Adequate nutritional state with Albumin ≥ 2.5 g/dL
Less than grade 2 pre-existing peripheral neuropathy (per CTCAE)
Patients covered by Health Insurance System
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
52 participants in 1 patient group
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Central trial contact
Laure Bordy; Anna BOROWIK
Data sourced from clinicaltrials.gov
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