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FOLFIRINOX + 9-ING-41 for Pancreatic Cancer

Phase 2

Recruiting

Led By Colin D Weekes, MD, PhD

Research Sponsored by Colin D. Weekes, M.D., PhD

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Participants with a history of hepatitis C virus (HCV) infection must have been treated and cured

ECOG performance status ≤1 (Karnofsky ≥ 70%)

Must not have

Patients taking strong inhibitors of CYP2C19, CYP3A4, and CYP1A2 or strong inducers of CYP3A4

Patients with known history of UGT1A1 gene polymorphism

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 30 months

Awards & highlights

No Placebo-Only Group

Summary

This trial will test if adding the drug 9-ING-41 to the standard treatment regimen of FOLFIRINOX will help to prevent metastatic pancreatic adenocarcinoma from becoming resistant to treatment.

Who is the study for?

This trial is for adults over 18 with newly diagnosed metastatic pancreatic adenocarcinoma who haven't had treatment for it yet. They must have a certain level of physical fitness and adequate organ function. People with HIV, HBV, or cured HCV can join. Those with controlled brain metastases may be eligible. Pregnant women can't participate unless they use contraception.

What is being tested?

The study tests if the experimental drug 9-ING-41 combined with FOLFIRINOX (a mix of four chemotherapy drugs) and Losartan prevents resistance to standard pancreatic cancer treatment in patients without prior therapy.

What are the potential side effects?

Potential side effects include reactions related to the immune system, blood disorders, fatigue, digestive issues due to chemotherapy drugs involved, and possible increased risk of infection.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I had hepatitis C but have been treated and cured.

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I am mostly able to care for myself and carry out daily activities.

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I have pancreatic cancer and haven't received any treatment for it.

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am not on strong medication that affects liver enzymes CYP2C19, CYP3A4, and CYP1A2.

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I have a known UGT1A1 gene variation.

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My pancreatic cancer is linked to a harmful BRCA gene mutation.

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I have not received a live vaccine in the last 30 days.

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I have not had major surgery in the last 4 weeks.

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I need medication for irregular heartbeats or have a type of heart block.

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My cancer has a high number of mutations or is unstable genetically.

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I have a bleeding disorder that is not under control.

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My cancer is positive for TRK fusion.

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I have never received any treatment for pancreatic cancer.

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I am currently taking cimetidine.

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I have an active tuberculosis infection.

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I am allergic to certain medications and cannot undergo desensitization.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 30 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 30 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 30 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Progression-free survival (PFS)

Secondary study objectives

Median time of maintenance therapy (mMT)

Objective Response Rate

Overall survival (OS)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

5Treatment groups

Experimental Treatment

Group I: Safety Run-In: FOLFIRINOX + 9-ING-41 + LosartanExperimental Treatment3 Interventions

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 of: * FOLFIRINOX * 5Fluorouracil portion of FOLFIRINOX on Days 1-3 of each 14 day study cycle * Irinotecan portion of FOLFIRINOX on Day 1 of each 14 day study cycle * Oxaliplatin portion of FOLFIRINOX on Day 1 of each 14 day study cycle * Leucovorin portion of FOLFIRINOX on Day 1 of each 14 day study cycle * 9-ING-41 on days on days 1, 3, 8, and 11 of every 14-day cycle * Losartan daily of every 14-day cycle.

Group II: FOLFIRNINOXExperimental Treatment1 Intervention

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: * 5Fluorouracil portion of FOLFIRINOX on Days 1-3 of each 14 day study cycle up to 12 cycles (24 weeks) * Irinotecan portion of FOLFIRINOX on Day 1 of each 14 day study cycle up to 12 cycles (24 weeks) * Oxaliplatin portion of FOLFIRINOX on Day 1 of each 14 day study cycle up to 12 cycles (24 weeks) * Leucovorin portion of FOLFIRINOX on Day 1 of each 14 day 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

Group III: FOLFIRINOX + LosartanExperimental Treatment2 Interventions

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: * FOLFIRINOX * 5Fluorouracil portion of FOLFIRINOX on Days 1-3 of each 14 day study cycle up to 12 cycles (24 weeks) * Irinotecan portion of FOLFIRINOX on Day 1 of each 14 day study cycle up to 12 cycles (24 weeks) * Oxaliplatin portion of FOLFIRINOX on Day 1 of each 14 day study cycle up to 12 cycles (24 weeks) * Leucovorin portion of FOLFIRINOX on Day 1 of each 14 day 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

Group IV: FOLFIRINOX + 9-ING-41 + LosartanExperimental Treatment3 Interventions

The study conducted in 3 parts depending on disease progression: Complete Therapy, Maintenance Therapy and Complete Therapy Round 2. For initial complete therapy: * FOLFIRINOX * 5Fluorouracil portion of FOLFIRINOX on Days 1-3 of each 14 day study cycle * Irinotecan portion of FOLFIRINOX on Day 1 of each 14 day study cycle * Oxaliplatin portion of FOLFIRINOX on Day 1 of each 14 day study cycle * Leucovorin portion of FOLFIRINOX on Day 1 of each 14 day study cycle * 9-ING-41 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 * 9-ING-41 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 + 9-ING-41+ Losartan until further disease progression

Group V: FOLFIRINOX + 9-ING-41Experimental Treatment2 Interventions

The study conducted in 3 parts depending on disease progression: Complete Therapy, Maintenance Therapy and Complete Therapy Round 2. For initial complete therapy: * FOLFIRINOX * 5Fluorouracil portion of FOLFIRINOX on Days 1-3 of each 14 day study cycle up to 12 cycles (24 weeks) * Irinotecan portion of FOLFIRINOX on Day 1 of each 14 day study cycle up to 12 cycles (24 weeks) * Oxaliplatin portion of FOLFIRINOX on Day 1 of each 14 day study cycle up to 12 cycles (24 weeks) * Leucovorin portion of FOLFIRINOX on Day 1 of each 14 day study cycle up to 12 cycles (24 weeks) * 9-ING-41 on days 1, 3, 8, and 11 of every 14-day cycle 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 * 9-ING-41 on days 1, 3, 8, and 11 of every 14-day cycle until disease progression For Complete Therapy Round 2, repeat of initial complete therapy until further disease progression

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

9-ING-41

2020

Completed Phase 2

~20

Losartan

2003

Completed Phase 4

~3000