Evaluating NALIRIFOX vs Modified Gemcitabine, Nab-Paclitaxel and Cisplatin in Patients With Local… (NCT07076212) | Clinical Trial Compass
RecruitingPhase 2
Evaluating NALIRIFOX vs Modified Gemcitabine, Nab-Paclitaxel and Cisplatin in Patients With Locally Advanced and Metastatic Pancreatic Adenocarcinoma
United States52 participantsStarted 2026-04-02
Plain-language summary
This is a single-center, open-label, randomized Phase 2 trial to evaluate the efficacy of NALIRIFOX (Arm 1) vs mGAP (Arm 2) in previously untreated patients with locally advanced (unresectable) and metastatic pancreatic ductal adenocarcinoma (PDAC).
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Provision of signed and dated informed consent form
* Stated willingness to comply with all study procedures and availability for the duration of the study
* Male or female, aged ≥18 years
* For females of reproductive potential: use of highly effective contraception for at least 1 month before screening and agreement to use such a method during study participation and for an additional 9 months after the end of the last dose of study medication administration
* Female patients including WOCBP must test negative for pregnancy at the time of screening based on a urine or serum pregnancy test.
* For males of reproductive potential: use of condoms or other methods to ensure effective contraception with a partner during the study and for 4 months after the last dose of study medication.
* Histologically or cytologically confirmed locally advanced or metastatic PDAC that has not been previously treated
* Radiographically confirmed measurable (per RECIST 1.1) locally advanced or metastatic PDAC per the National Comprehensive Cancer Network (NCCN) definition.
* Inoperable status due to the presence of locally advanced, unresectable disease with or metastases.
* Eastern Cooperative Oncology Group (ECOG) performance status 0-2
* Hematological, biochemical, and organ function inclusion criteria:
* Absolute neutrophil count (ANC) ≥1500/mm3 without the use of hemopoietic growth factors within 7 days before treatment
* Platelet count ≥100,000/mm3.
* Internati…