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Mutant IDH1 Inhibitor
Ivosidenib + mFOLFIRINOX for Pancreatic Cancer
Phase 1
Recruiting
Led By David Bajor, MD
Research Sponsored by Case Comprehensive Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Subjects must have histologically or cytologically confirmed diagnosis of pancreatic adenocarcinoma or adenosquamous carcinoma
No evidence of clinically significant active infection and no serious or chronic infection requiring ongoing antibiotics
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 24 months from the start of treatment
Awards & highlights
Study Summary
This trial is testing a new cancer drug, ivosidenib, to see if it is effective when used with another standard cancer drug, mFOLFIRINOX. Up to 15 people with a certain kind of cancer, PDA, that can be removed by surgery will participate.
Who is the study for?
This trial is for adults over 18 with resectable pancreatic cancer, specifically adenocarcinoma or adenosquamous carcinoma. They must be in good health overall, have a life expectancy of at least 3 months, and not have had previous treatments for pancreatic cancer. Women who can bear children and men must use contraception.Check my eligibility
What is being tested?
The study tests the effectiveness of ivosidenib combined with mFOLFIRINOX chemotherapy before surgery in patients with certain types of pancreatic cancer. It's a phase I trial to see how well this combination works as an initial treatment.See study design
What are the potential side effects?
Ivosidenib may cause side effects like fatigue, joint pain, skin problems or changes in blood counts which could lead to infections or bleeding issues. The mFOLFIRINOX regimen has its own risks including nausea, diarrhea, low blood cell counts and nerve damage.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer is confirmed as pancreatic adenocarcinoma or adenosquamous carcinoma.
Select...
I don't have any serious infections or need for ongoing antibiotics.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 24 months from the start of treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 24 months from the start of treatment
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Maximum-tolerated dose (MTD) or Recommended Phase 2 dose (RP2D)
Secondary outcome measures
Biochemical response rates
Major pathologic response rates
RECIST version 1.1 response rates.
Side effects data
From 2021 Phase 3 trial • 187 Patients • NCT0298985728%
Nausea
28%
Diarrhoea
23%
Fatigue
21%
Oedema peripheral
16%
Abdominal pain
16%
Anaemia
14%
Decreased appetite
14%
Weight decreased
12%
Vomiting
12%
Asthenia
12%
Cough
12%
Ascites
12%
Constipation
12%
Arthralgia
9%
Hypertension
9%
Abdominal pain upper
9%
Dizziness
9%
Muscle spasms
9%
Muscular weakness
9%
Dyspnoea
9%
Blood alkaline phosphatase increased
7%
Upper respiratory tract infection
7%
Hypoalbuminaemia
7%
Pruritus
7%
Hypophosphataemia
7%
Aspartate aminotransferase increased
7%
Alanine aminotransferase increased
7%
Insomnia
7%
Abdominal discomfort
5%
Hypokalaemia
5%
Rash
5%
Back pain
5%
White blood cell count decreased
5%
Hyperglycaemia
5%
Hyperkalaemia
5%
Pyrexia
5%
Headache
5%
Abdominal distension
5%
Blood bilirubin increased
5%
Confusional state
5%
Platelet count decreased
2%
Electrocardiogram QT prolonged
2%
Chills
2%
Cholangitis
2%
Gastrointestinal haemorrhage
2%
Intestinal pseudo-obstruction
2%
Biliary obstruction
2%
Bacteraemia
2%
Clostridium difficile colitis
2%
Escherichia bacteraemia
2%
Hip fracture
2%
Hypercalcaemia
2%
Encephalopathy
2%
Acute kidney injury
2%
Hypotension
2%
Gastrooesophageal reflux disease
2%
Hypomagnesaemia
2%
Blood creatinine increased
2%
Dyspepsia
2%
Urinary tract infection
2%
Rash maculo-papular
2%
Dry mouth
2%
Multiple sclerosis relapse
2%
Spinal cord compression
2%
Syncope
2%
Hyponatraemia
2%
Hepatic cirrhosis
2%
Oesophageal varices haemorrhage
2%
Upper gastrointestinal haemorrhage
100%
80%
60%
40%
20%
0%
Study treatment Arm
After Cross Over to AG-120
AG-120
Placebo
Trial Design
1Treatment groups
Experimental Treatment
Group I: Ivosidenib+mFOLFIRINOXExperimental Treatment2 Interventions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ivosidenib
FDA approved
mFOLFIRINOX
2013
Completed Phase 2
~40
Find a Location
Who is running the clinical trial?
Case Comprehensive Cancer CenterLead Sponsor
452 Previous Clinical Trials
31,894 Total Patients Enrolled
David Bajor, MDPrincipal InvestigatorUniversity Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
3 Previous Clinical Trials
152 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My pancreatic cancer has spread, as shown by scans.I have a serious illness that could make treatment more risky for me.I do not have any severe ongoing illnesses that would interfere with the study.I am fully active or can carry out light work.I am not pregnant, breastfeeding, or if capable of becoming pregnant, I am using reliable contraception.I am using birth control and my pregnancy test was negative.I have had treatment for pancreatic cancer before.I am a man who can father children and will not use birth control during the study.My organ and bone marrow functions are normal.My pancreatic cancer can be surgically removed and is located on the right side.I am not HIV-positive or not on antiretroviral therapy.My cancer is confirmed as pancreatic adenocarcinoma or adenosquamous carcinoma.My pancreatic cancer is advanced or has come back.I am under 18 years old.My cancer is a type of pancreatic cancer.I had a heart attack less than 3 months ago.I am older than 18 years.I don't have any serious infections or need for ongoing antibiotics.My pancreatic cancer cannot be removed by surgery or is in the left side (body/tail) and can be.I do not have any ongoing, uncontrolled bleeding issues.
Research Study Groups:
This trial has the following groups:- Group 1: Ivosidenib+mFOLFIRINOX
Awards:
This trial has 3 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Approved for 5 Other Conditions - This treatment demonstrated efficacy for 5 other conditions.
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.
Is enrollment for this clinical trial still available?
"Clinicaltrials.gov's data suggests this medical trial is open to recruitment, having been posted on September 8th 2022 and updated most recently on the 28th of the same month."
Answered by AI
Does the experiment accept participants over a certain age threshold?
"This medical research requires that potential participants be aged between 18 and 80 to qualify for enrollment."
Answered by AI
Is enrollment open for this research trial?
"This clinical trial seeks to enrol 16 individuals diagnosed with ductal adenocarcinoma of the pancreas, ranging from 18-80 years old. Eligible candidates must meet numerous criteria including acceptable hematological values, normalised hepatic function, renal health, coagulation levels and an anticipated life expectancy in excess of three months. Furthermore there is a requirement for screening HgbA1C to be lower than 6.5%. Both genders are accepted into this study as long as they exceed eighteen years of age at the point of enrollment."
Answered by AI
Has the Food and Drug Administration (FDA) endorsed mFOLFIRINOX as a viable treatment option?
"Our team at Power has evaluated the safety of mFOLFIRINOX and, due to there being limited data available in respect to efficacy and safety, gave it a score of 1."
Answered by AI
How many participants can take part in this research endeavor?
"Correct. Clinicaltrials.gov confirms that this research project, which was originally published on September 8th 2022, is actively searching for participants. 16 individuals will be accepted to take part in the trial at 1 medical facility."
Answered by AI
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