FOLFIRINOX + Elraglusib + Losartan In Pancreatic Cancer (NCT05077800) | Clinical Trial Compass
Active — Not RecruitingPhase 2
FOLFIRINOX + Elraglusib + Losartan In Pancreatic Cancer
United States70 participantsStarted 2022-03-21
Plain-language summary
The purpose of this study is to find out if an experimental drug will prevent metastatic pancreatic adenocarcinoma from becoming resistant to standard treatment for the disease.
The names of the study drugs involved in this study are:
* 9-ING-41
* Losartan
* Ferumoxytol
* FOLFIRINOX (made up of 4 different drugs):
* 5-Fluorouracil (5-FU)
* Oxaliplatin
* Irinotecan
* Leucovorin
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Histologically confirmed metastatic pancreatic adenocarcinoma without prior therapy for pancreatic adenocarcinoma.
* Participants must have measurable disease as defined by RECIST 1.1
* Age ≥18 years.
* ECOG performance status ≤1 (Karnofsky ≥ 70%, see Appendix A).
* Participants must have adequate organ and marrow function as defined below:
* Absolute neutrophil count (ANC) ≥ 1,500/mcL
* Platelets ≥ 100,000/mcL
* Total bilirubin ≤ 1.5 institutional upper limit of normal (ULN) if no biliary stenting has been done OR 2.0 x ULN if patient is status post biliary stenting or two downward trending values.
* AST(SGOT)/ALT(SGPT) \< 5 x institutional ULN.
* Creatinine ≤ 1.5 mg/dL OR .
* Creatinine clearance ≥ 30 mL/min (as estimated by Cockcroft Gault Equation)
(140 - age \[yrs\]) (body wt \[kg\]) Creatinine clearance for males = ------------ (72) (serum creatinine \[mg/dL\])
* Creatinine clearance for females = 0.85 x male value
* Prior treatment with angiotensin receptor blocker (ARB) for hypertension is allowed. If the patient is randomized to a non-losartan containing treatment arm, the patient must be changed to an antihypertensive medication that is not in the class of angiotensin receptor blocker (ARB).
* Human immunodeficiency virus (HIV)-infected participants on effective anti-retroviral therapy within 6 months are eligible for this trial.
* Participants with evidence of chronic hepatitis B virus (HBV) infection on suppressive therap…
What they're measuring
1
Progression-free survival (PFS)
Timeframe: Date of study entry to the earliest date of progressive disease up to 30 months