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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%)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 30 months
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
I had hepatitis C but have been treated and cured.
Select...
I am mostly able to care for myself and carry out daily activities.
Select...
I have pancreatic cancer and haven't received any treatment for it.
Select...
I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 30 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 30 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Progression-free survival (PFS)
Secondary outcome measures
Median time of maintenance therapy (mMT)
Objective Response Rate
Overall survival (OS)
Side effects data
From 2016 Phase 4 trial • 48 Patients • NCT0152974920%
Hepatitis C
20%
Sexual transmitted diseases
10%
Post lumbar puncture headache
10%
Abdominal pain
100%
80%
60%
40%
20%
0%
Study treatment Arm
FTC/TDF+MK-0518+Losartan
EFV/FTC/TDF + Losartan
FTC/TDF + MK-0518
EFV/FTC/TDF
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
Find a Location
Who is running the clinical trial?
Colin D. Weekes, M.D., PhDLead Sponsor
Lustgarten FoundationOTHER
23 Previous Clinical Trials
5,303 Total Patients Enrolled
Colin D. Weekes, M.D.Lead Sponsor
1 Previous Clinical Trials
50 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My organs and bone marrow are functioning well.I am not on strong medication that affects liver enzymes CYP2C19, CYP3A4, and CYP1A2.I have another cancer, but it won't affect this trial's treatment.I had hepatitis C but have been treated and cured.I have a known UGT1A1 gene variation.I am mostly able to care for myself and carry out daily activities.My doctor says I don't need immediate treatment for my brain metastases.My pancreatic cancer is linked to a harmful BRCA gene mutation.I have a heart condition or have been treated with heart-toxic drugs and need a heart function assessment.I have not received a live vaccine in the last 30 days.I am on treatment for chronic hepatitis B.I have recovered from side effects of previous cancer treatments, except for hair loss.I have not had major surgery in the last 4 weeks.I need medication for irregular heartbeats or have a type of heart block.My cancer has a high number of mutations or is unstable genetically.I have a bleeding disorder that is not under control.My cancer is positive for TRK fusion.I have never received any treatment for pancreatic cancer.I am currently taking cimetidine.I have an active tuberculosis infection.My brain cancer has not worsened after treatment.My doctor has a reason if my brain metastases exclude me from the study.I have pancreatic cancer and haven't received any treatment for it.I have taken ARB medication for high blood pressure.I am allergic to certain medications and cannot undergo desensitization.I am HIV positive and have been on effective treatment for the last 6 months.I am 18 years old or older.
Research Study Groups:
This trial has the following groups:- Group 1: Safety Run-In: FOLFIRINOX + 9-ING-41 + Losartan
- Group 2: FOLFIRNINOX
- Group 3: FOLFIRINOX + Losartan
- Group 4: FOLFIRINOX + 9-ING-41 + Losartan
- Group 5: FOLFIRINOX + 9-ING-41
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
To what maladies is 9-ING-41 typically prescribed?
"9-ING-41 has been medically approved to treat diabetic nephropathy, left ventricular hypertrophy and proteinuria."
Answered by AI
Has 9-ING-41 obtained regulatory approval from the Food and Drug Administration?
"Our team evaluated 9-ING-41's safety as a 2, due to the lack of clinical evidence backing up its efficacy but existing data suggesting it is safe."
Answered by AI
What is the current sample size of this clinical trial?
"Affirmative. The information posted on clinicaltrials.gov reveals that this research trial, which was initially launched on March 21st 2022, is currently looking for participants. 70 individuals need to be enrolled from one medical centre."
Answered by AI
Are there currently any openings in this medical research study?
"According to clinicaltrials.gov, this medical study is actively enrolling patients and has been open since March 21st 2022. The trial was recently updated on June 7th 2022."
Answered by AI
Can you elaborate on the prior experiments that have included 9-ING-41 as a component?
"Presently, there are 34 clinical trials in progress investigating the therapeutic effects of 9-ING-41. Of these, 2 have reached Phase 3 while most are based in San Francisco, California. Nonetheless, studies for this medication can be found at 571 sites worldwide."
Answered by AI
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