Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
FOLFIRNINOX · 1 trial · 2 indications
Defined from the date of study entry to the earliest date of progressive disease while receiving complete therapy with FOLFIRINOX-based therapy or death due to any cause. PFS will be censored at the date of last follow-up for patients alive without documented progression. PFS curves will be estimated by the Kaplan-Meier method and compared to historical controls treated with FOLFIRINOX alone using the one-sample log-rank test.
| Arm | Type | Description |
|---|---|---|
| Safety Run-In: FOLFIRINOX + Elraglusib + Losartan | EXPERIMENTAL | The study will begin with a Safety Run-In phase to establish the side effects from the study treatment to its safety before beginning the main part of the study, six (6) participants will receive 1-2 cycles (each study cycle is 14 days +/- 3 days) of: * FOLFIRINOX * 5Fluorouracil portion of FOLFIRINOX on Days 1-3 of each study cycle * Irinotecan portion of FOLFIRINOX on Day 1 of each study cycle * Oxaliplatin portion of FOLFIRINOX on Day 1 of each study cycle * Leucovorin portion of FOLFIRINOX on Day 1 of each study cycle The FOLFIRINOX treatment regimen will be given every 14 days +/- 3 days at physician discretion. * Elraglusib on days on days 1, 3, 8, and 11 of every 14-day cycle * Losartan daily of every 14-day cycle. |
| FOLFIRNINOX | EXPERIMENTAL | The study will be conducted in three parts depending on participant disease progression: Complete Therapy, Maintenance Therapy and Complete Therapy Round 2. For initial complete therapy, participants will receive FOLFIRINOX as follows (each study cycle is 14 days +/- 3 days, FOLFIRINOX can be given +/- 3 days): * 5Fluorouracil portion of FOLFIRINOX on Days 1-3 of each study cycle up to 12 cycles (24 weeks) * Irinotecan portion of FOLFIRINOX on Day 1 of each study cycle up to 12 cycles (24 weeks) * Oxaliplatin portion of FOLFIRINOX on Day 1 of each study cycle up to 12 cycles (24 weeks) * Leucovorin portion of FOLFIRINOX on Day 1 of each study cycle up to 12 cycles (24 weeks) For Maintenance therapy, participants will receive FOLFIRINOX as follows: * 5Fluorouracil portion of FOLFIRINOX on Days 1-3 of each 14 day study cycle until disease progression For Complete Therapy Round 2, participants will repeat initial complete therapy of FOLFIRINOX until further disease progression |
| FOLFIRINOX + Losartan | EXPERIMENTAL | The study will be conducted in three parts depending on participant disease progression: Complete Therapy, Maintenance Therapy and Complete Therapy Round 2. For initial complete therapy (each study cycle is 14 days +/- 3 days): * FOLFIRINOX (+/- 3 days) * 5Fluorouracil portion of FOLFIRINOX on Days 1-3 of each study cycle up to 12 cycles (24 weeks) * Irinotecan portion of FOLFIRINOX on Day 1 of each study cycle up to 12 cycles (24 weeks) * Oxaliplatin portion of FOLFIRINOX on Day 1 of each study cycle up to 12 cycles (24 weeks) * Leucovorin portion of FOLFIRINOX on Day 1 of each study cycle up to 12 cycles (24 weeks) * Losartan daily up to 12 cycles (24 weeks) For Maintenance therapy: * 5Fluorouracil portion of FOLFIRINOX on Days 1-3 of each 14 day study cycle until disease progression * Losartan daily until disease progression For Complete Therapy Round 2, participants will repeat initial complete therapy of FOLFIRINOX + Losartan until further disease progression |
| FOLFIRINOX + Elraglusib | EXPERIMENTAL | The study conducted in 3 parts depending on disease progression: Complete Therapy, Maintenance Therapy and Complete Therapy Round 2 For initial complete therapy (each study cycle is 14 days +/- 3 days): * FOLFIRINOX (+/- 3 days) * 5Fluorouracil portion of FOLFIRINOX on Days 1-3 of each study cycle up to 12 cycles (24 weeks) * Irinotecan portion of FOLFIRINOX on Day 1 of each study cycle up to 12 cycles (24 weeks) * Oxaliplatin portion of FOLFIRINOX on Day 1 of each study cycle up to 12 cycles (24 weeks) * Leucovorin portion of FOLFIRINOX on Day 1 of each study cycle up to 12 cycles (24 weeks) * Elraglusib on days 1, 3, 8, and 11 of every study cycle up to 12 cycles (24 weeks) For Maintenance therapy: * 5Fluorouracil portion of FOLFIRINOX on Days 1-3 of each study cycle until disease progression * Elraglusib on days 1, 3, 8, and 11 of every study cycle until disease progression For Complete Therapy Round 2, repeat of initial complete therapy until further disease progression |
| FOLFIRINOX + Elraglusib + Losartan | EXPERIMENTAL | The study conducted in 3 parts depending on disease progression: Complete Therapy, Maintenance Therapy and Complete Therapy Round 2. For initial complete therapy (each study cycle is 14 days +/- 3 days): * FOLFIRINOX (+/- 3 days) * 5Fluorouracil portion of FOLFIRINOX on Days 1-3 of each study cycle * Irinotecan portion of FOLFIRINOX on Day 1 of each study cycle * Oxaliplatin portion of FOLFIRINOX on Day 1 of each study cycle * Leucovorin portion of FOLFIRINOX on Day 1 of each study cycle * Elraglusib on days 1, 3, 8, and 11 of every 14-day cycle * Losartan daily For Maintenance therapy: * 5Fluorouracil portion of FOLFIRINOX on Days 1-3 of each 14 day study cycle until disease progression * Elraglusib on days 1, 3, 8, and 11 of every 14-day cycle until disease progression * Losartan daily until disease progression For Complete Therapy Round 2, participants will repeat initial complete therapy of FOLFIRINOX + Elraglusib + Losartan until further disease progression |
| Name | Type | Description |
|---|---|---|
| FOLFIRNINOX | DRUG | Combination of 4 different drugs (5-Fluorouracil (5-FU), Oxaliplatin, Irinotecan and Leucovorin) administered by intravenous infusion |
| Losartan | DRUG | Taken Orally |
| 9-ING-41 | DRUG | Administered by intravenous infusion |
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). * Participan...
FOLFIRINOX is a chemotherapy regimen used for pancreatic adenocarcinoma, including metastatic pancreatic adenocarcinoma. It is being studied in combination with elraglusib and losartan in a Phase 2 clinical trial for this indication.
FOLFIRINOX is being developed by Actuate Therapeutics, Inc., a company traded under the ticker ACTU. The company is sponsoring a Phase 2 clinical trial evaluating FOLFIRINOX in combination with elraglusib and losartan for pancreatic cancer.
FOLFIRINOX is in Phase 2 clinical development for pancreatic adenocarcinoma. It is an investigational regimen and has not been approved by the FDA for this use. The Phase 2 trial is active but not recruiting participants.
FOLFIRINOX is being studied in a Phase 2 trial with the identifier NCT05077800, titled 'FOLFIRINOX + Elraglusib + Losartan In Pancreatic Cancer'. This randomized, controlled trial has an enrollment of 70 participants and is being conducted in the United States.
No, FOLFIRINOX is a chemotherapy regimen, while elraglusib and losartan are separate drugs being tested in combination with it. The Phase 2 trial NCT05077800 evaluates the combination of FOLFIRINOX, elraglusib, and losartan in patients with pancreatic adenocarcinoma.