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Compares treatment options for Metastatic Pancreatic Adenocarcinoma
Official title Evaluating NALIRIFOX vs Modified Gemcitabine, Nab-Paclitaxel and Cisplatin in Patients With Locally Advanced and Metastatic Pancreatic Adenocarcinoma
ClinicalTrials.gov ID: NCT07076212
What this study is testing
What is Liposomal Irinotecan?
Liposomal Irinotecan is an investigational medicine, given as a treatment applied to the skin, being studied as a potential treatment for metastatic pancreatic adenocarcinoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- Female patients including WOCBP must test negative for pregnancy at the time of screening based on a urine or serum pregnancy test.
You likely can't join if
- 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...
- Unwilling or unable to comply with study procedures and/or study visits.
- Uncontrolled, active infection
See the full eligibility 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...
- 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
- 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...
- Adequate renal function, as evidenced by serum/plasma creatinine level \<1.6 mg/dL
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Charleston, South Carolina, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Charleston, South Carolina, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.