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New treatment option for Pancreatic Ductal Adenocarcinoma
Official title Monthly Alternating NALIRIFOX and GnP in the First-Line Setting for Metastatic Pancreatic Ductal Adenocarcinoma
ClinicalTrials.gov ID: NCT07163273
What this study is testing
What is NALIRIFOX?
NALIRIFOX is an investigational medicine, given as a monthly, being studied as a potential treatment for pancreatic ductal adenocarcinoma.
Also referred to as 5fu/ leucovorin / oxaliplatin / liposomal irinotecan.
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
- A prospective, interventional, single-center, single-arm, open-label, phase II study for patients with metastatic pancreatic cancer. The intervention consists of monthly alternating standard chemotherapy regimens-NALIRIFOX and GnP.
- Phase 2: a mid-size study of how well it works
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
- Inclusion:
- \>18 years of age
- Histologically proven pancreatic ductal adenocarcinoma, poorly differentiated carcinoma, or adenosquamous carcinoma
- Radiographic evidence of metastatic disease
- At least 1 measurable target lesion per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
See the full eligibility criteria
- Inclusion:
- \>18 years of age
- Histologically proven pancreatic ductal adenocarcinoma, poorly differentiated carcinoma, or adenosquamous carcinoma
- Radiographic evidence of metastatic disease
- At least 1 measurable target lesion per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
- Metastatic relapse of previously resected pancreatic cancer is allowed provided the patient is more than 6 months from last SOC adjuvant treatment
- ECOG PS 0-1
- Laboratory assessments within 14 days as indicated below:
- Hemoglobin \> 9.0 g/dL (patients with hemoglobin \< 9 g/dL may be transfused prior to study enrollment)
- Platelet count \> 100 x 10\^9/L
- Absolute neutrophil count (ANC) \> 1.5 x 10\^9/L
- Total bilirubin \< 3 x upper limit of normal (ULN)
- Aspartate transaminase (AST) and alanine transaminase (ALT) \< 3 x ULN (if liver metastases are present, AST and ALT \< 5 x ULN is permitted.
- Creatinine ≤1.5 ULN
- Creatinine clearance \> 40 mL/min as calculated by Cockcroft-Gault formula
- APTT (aPTT) ≤ 1.5 × ULN. For people receiving unfractionated heparin \< 2.5 × ULN, or within acceptable range considered by the investigator.
- PT/INR INR ≤ 1.5 × ULN. For people receiving warfarin, 2.0 -3.0, or within acceptable range considered by the investigator.
- Women of childbearing potential must be surgically sterile or postmenopausal or must have a negative pregnancy test (serum or urine) prior to study enrolment and must use effective barrier contraception or abstinence...
- Ability to understand and willing to sign informed consent form Exclusion:
- A history of other disease, metabolic dysfunction, physical examination finding or clinical laboratory test result suspicious of a disease or condition which, in the opinion of the investigator, would compromise patient...
- Ampullary, acinar, squamous, and neuroendocrine histology
- Presence of central nervous system metastases
- Life expectancy \< 12 weeks
- Pregnant or breastfeeding women
- Prior neuropathy \> grade 1 as per CTCAE v5
- Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association...
- Major surgery within 4 weeks prior to initiation of the study treatment, without full recovery
- Any past chemotherapy delivered for metastatic pancreatic cancer
- Known somatic or germline mutations in BRCA1, BRCA2, or PALB2
- Active second malignancy whose prognosis has a high likelihood of impacting survival
- 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 interfere with the interpretation...
The study team makes the final eligibility decision.
Where it's taking place
- Bay Shore, New York, United States
- Mount Kisco, New York, United States
- New Hyde Park, New York, United States
- New York, New York, United States
- Rego Park, New York, United States
- Sleepy Hollow, New York, 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 Bay Shore, New York, United States; Mount Kisco, New York, United States; New Hyde Park, New York, United States; New York, New York, United States; Rego Park, New York, United States; Sleepy Hollow, New York, 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.