mFOLFIRINOX for Pancreatic Cancer

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center, Cleveland, OHPancreatic Cancer+1 MoremFOLFIRINOX - Drug
Eligibility
18 - 80
All Sexes
What conditions do you have?
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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.

Eligible Conditions
  • Pancreatic Cancer
  • Resectable Pancreatic Cancer

Treatment Effectiveness

Effectiveness Progress

1 of 3

Similar Trials

1
Omeprazole
1
AG-120
1
ribociclib

Study Objectives

1 Primary · 4 Secondary · Reporting Duration: Up to 24 months from the start of treatment

Month 24
Maximum-tolerated dose (MTD) or Recommended Phase 2 dose (RP2D)
Week 24
Biochemical response rates
Major pathologic response rates
RECIST version 1.1 response rates.
iRECIST version 1.1 response rates.

Trial Safety

Safety Progress

1 of 3

Similar Trials

1
Omeprazole
1
AG-120
1
ribociclib

Side Effects for

After Cross Over to AG-120
28%Diarrhoea
28%Nausea
23%Fatigue
21%Oedema peripheral
16%Anaemia
16%Abdominal pain
14%Decreased appetite
14%Weight decreased
12%Constipation
12%Asthenia
12%Arthralgia
12%Ascites
12%Cough
12%Vomiting
9%Dizziness
9%Blood alkaline phosphatase increased
9%Abdominal pain upper
9%Dyspnoea
9%Hypertension
9%Muscle spasms
9%Muscular weakness
7%Hypoalbuminaemia
7%Aspartate aminotransferase increased
7%Pruritus
7%Upper respiratory tract infection
7%Alanine aminotransferase increased
7%Hypophosphataemia
7%Insomnia
7%Abdominal discomfort
5%Pyrexia
5%Headache
5%Blood bilirubin increased
5%Rash
5%Hyperglycaemia
5%Confusional state
5%Hypokalaemia
5%White blood cell count decreased
5%Hyperkalaemia
5%Back pain
5%Abdominal distension
5%Platelet count decreased
2%Intestinal pseudo-obstruction
2%Spinal cord compression
2%Oesophageal varices haemorrhage
2%Encephalopathy
2%Urinary tract infection
2%Hyponatraemia
2%Gastrooesophageal reflux disease
2%Hypercalcaemia
2%Cholangitis
2%Multiple sclerosis relapse
2%Rash maculo-papular
2%Blood creatinine increased
2%Gastrointestinal haemorrhage
2%Biliary obstruction
2%Bacteraemia
2%Clostridium difficile colitis
2%Escherichia bacteraemia
2%Hypomagnesaemia
2%Hip fracture
2%Syncope
2%Hypotension
2%Dyspepsia
2%Electrocardiogram QT prolonged
2%Chills
2%Upper gastrointestinal haemorrhage
2%Hepatic cirrhosis
2%Acute kidney injury
2%Dry mouth
This histogram enumerates side effects from a completed 2021 Phase 3 trial (NCT02989857) in the After Cross Over to AG-120 ARM group. Side effects include: Diarrhoea with 28%, Nausea with 28%, Fatigue with 23%, Oedema peripheral with 21%, Anaemia with 16%.

Trial Design

1 Treatment Group

Ivosidenib+mFOLFIRINOX
1 of 1

Experimental Treatment

16 Total Participants · 1 Treatment Group

Primary Treatment: mFOLFIRINOX · No Placebo Group · Phase 1

Ivosidenib+mFOLFIRINOXExperimental Group · 2 Interventions: mFOLFIRINOX, Ivosidenib · Intervention Types: Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
mFOLFIRINOX
2013
Completed Phase 2
~40

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 24 months from the start of treatment

Who is running the clinical trial?

Case Comprehensive Cancer CenterLead Sponsor
432 Previous Clinical Trials
30,466 Total Patients Enrolled
David Bajor, MDPrincipal InvestigatorUniversity Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
3 Previous Clinical Trials
152 Total Patients Enrolled

Eligibility Criteria

Age 18 - 80 · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
References

Frequently Asked Questions

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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