No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
52 (estimated)
Sponsor
Medical University of South Carolina · Other
Who this trial is looking for
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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).
Trial Locations
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City
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Status
Eligibility Criteria
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 le…
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.
* International normalized ratio (INR) \<1.5 unless the patient is receiving anticoagulation therapy, in which case a therapeutic INR is acceptable. Anticoagulation therapy with low-molecular weight heparin or warfarin, whether medically indicated, is permitted.
* Adequate renal function, as evidenced by serum/plasma creatinine level \<1.6 mg/dL
Exclusion Criteria:
* Pregnancy or lactation
* Treatment with another investigational drug or other intervention within 30 days of protocol initiation.
* Known hypersensitivity/allergic reaction to any of the components of the therapeutic agents in mGAP or NALIRIFOX.
* Any other medical or social condition deemed by the investigator to be likely to interfere with a subject's ability to sign informed consent, cooperate, and participate in the study or who is likely to interfere with the interpretation of the results.
* Unwilling or unable to comply with study procedures and/or study visits.
* Uncontrolled, active infection
* Histologic diagnosis other than adenocarcinoma.
* Medical co-morbidities, that preclude major abdominal surgery
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