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Enzyme Inhibitor
Devimistat + Chemoradiation for Pancreatic Cancer
Phase 1
Recruiting
Led By Mandana Kamgar, MD, MPH
Research Sponsored by Medical College of Wisconsin
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Pathologically confirmed adenocarcinoma of the pancreas
Age ≥ 18 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up start of study treatment until 30 days after completion of study treatment.
Awards & highlights
Study Summary
This trial is testing a new cancer drug CPI-613 in patients with pancreatic cancer. The goal is to find the maximum tolerated dose and learn about the safety profile.
Who is the study for?
This trial is for adults with confirmed pancreatic adenocarcinoma who cannot undergo surgery. They should have adequate blood cell counts, not be on hemodialysis, and have liver function within acceptable limits. Women of childbearing potential and men must agree to use effective contraception. Those with severe illnesses or conditions that could interfere with the study are excluded.Check my eligibility
What is being tested?
The trial is testing various doses of CPI-613 (Devimistat) in combination with chemoradiation to find the highest dose patients can tolerate without severe side effects. It's an early-phase study focusing on safety and determining the right dosage for further research.See study design
What are the potential side effects?
Specific side effects aren't listed here, but generally, participants may experience reactions related to CPI-613 or chemoradiation such as nausea, fatigue, blood count changes, or organ inflammation. The maximum tolerated dose aims to minimize these while being effective.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer is a type of pancreatic cancer called adenocarcinoma.
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I am 18 years old or older.
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My cancer cannot be removed by surgery and needs chemoradiation for treatment.
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I can stay still for radiation therapy.
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I am following the required birth control measures.
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My blood counts and liver function are within safe ranges, and I'm not on dialysis.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ initiation of treatment to 30 days after treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~initiation of treatment to 30 days after 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 of CPI-613®
Secondary outcome measures
The number of subjects with adverse events related to the treatment
Side effects data
From 2012 Phase 3 trial • 256 Patients • NCT0100568051%
Neutropenia
47%
Leukopenia
46%
Nausea
43%
Vomiting
35%
Anaemia
31%
Decreased appetite
26%
Haemoglobin decreased
26%
Fatigue
25%
Constipation
25%
White blood cell count decreased
24%
Neutrophil count decreased
19%
Alanine aminotransferase increased
13%
Platelet count decreased
12%
Rash
10%
Aspartate aminotransferase increased
10%
Thrombocytopenia
9%
Blood sodium decreased
8%
Hypokalaemia
7%
Insomnia
7%
Pyrexia
6%
Hyponatraemia
6%
Blood creatinine increased
6%
Lymphopenia
6%
Diarrhoea
6%
Dyspepsia
6%
Red blood cell count decreased
6%
Cough
4%
Dizziness
2%
Bone marrow failure
1%
Ischaemic stroke
1%
Dyspnoea
1%
Cerebral infarction
1%
Pulmonary embolism
1%
Embolism venous
1%
Superior vena cava syndrome
100%
80%
60%
40%
20%
0%
Study treatment Arm
Gemcitabine Plus Cisplatin (GC)
Pemetrexed Plus Cisplatin (PC)
Trial Design
5Treatment groups
Experimental Treatment
Group I: CPI-613® Maximum Tolerated Dose (MTD)Experimental Treatment7 Interventions
MTD of CPI-613® from initiation of treatment to 30 days after treatment. MTD will be determined by testing increasing doses of CPI-613®, starting from 500 mg/m^2 and up to 1,500 mg/m^2, on dose escalation cohorts of three patients (maximum 24 patients) in combination with Gem-RT therapy. MTD reflects the highest drug dose that does not cause unacceptable adverse effects, with a target dose-limiting toxicity (DLT) rate of 30%. Final dose will be revised as appropriate.
Group II: CPI-613® (Dose level 3.0 1,500 mg/m^2)Experimental Treatment3 Interventions
Dose escalation/de-escalation for CPI-613® (devimistat) will be conducted using a Bayesian optimal interval (BOIN) design. Gemcitabine will be infused over 30 minutes at a fixed dose of 400 mg/m^2 weekly. Intensity-modulated radiation therapy will be administered at 54 Gy in 30 fractions of 1.8 Gy per fraction, with five fractions given per week. CPI-613® will be given once per week by IV infusion.
Group III: CPI-613® (Dose level 2.0 1,000 mg/m^2)Experimental Treatment3 Interventions
Dose escalation/de-escalation for CPI-613® (devimistat) will be conducted using a Bayesian optimal interval (BOIN) design. Gemcitabine will be infused over 30 minutes at a fixed dose of 400 mg/m^2 weekly. Intensity-modulated radiation therapy will be administered at 54 Gy in 30 fractions of 1.8 Gy per fraction, with five fractions given per week. CPI-613® will be given once per week by IV infusion.
Group IV: CPI-613® (Dose level 1.0 500 mg/m^2)Experimental Treatment3 Interventions
Dose escalation/de-escalation for CPI-613® (devimistat) will be conducted using a Bayesian optimal interval (BOIN) design. Gemcitabine will be infused over 30 minutes at a fixed dose of 400 mg/m^2 weekly. Intensity-modulated radiation therapy will be administered at 54 Gy in 30 fractions of 1.8 Gy per fraction, with five fractions given per week. CPI-613® will be given once per week by IV infusion.
Group V: CPI-613® (Dose level -1.0 250 mg/m^2)Experimental Treatment3 Interventions
Dose escalation/de-escalation for CPI-613® (devimistat) will be conducted using a Bayesian optimal interval (BOIN) design. Gemcitabine will be infused over 30 minutes at a fixed dose of 400 mg/m^2 weekly. Intensity-modulated radiation therapy will be administered at 54 Gy in 30 fractions of 1.8 Gy per fraction, with five fractions given per week. CPI-613® will be given once per week by IV infusion.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Gemcitabine
2017
Completed Phase 3
~2070
Find a Location
Who is running the clinical trial?
Barbara Ann Karmanos Cancer InstituteOTHER
163 Previous Clinical Trials
9,232 Total Patients Enrolled
Medical College of WisconsinLead Sponsor
610 Previous Clinical Trials
1,162,507 Total Patients Enrolled
Cornerstone PharmaceuticalsIndustry Sponsor
13 Previous Clinical Trials
837 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I've had the required scans and blood tests within the last 30 days.I have not had major surgery in the last 28 days.I've had a check-up, including weight and vital signs, within the last 30 days.I can take care of myself and am up and about more than half of my waking hours.My cancer is a type of pancreatic cancer called adenocarcinoma.I haven't had any other cancer besides skin cancer in the last 2 years.I have had radiation therapy on the area where my cancer is located.I am 18 years old or older.I am following pregnancy prevention measures.I am not pregnant and willing to use contraception.I may or may not have swollen lymph nodes.My cancer cannot be removed by surgery and needs chemoradiation for treatment.I can stay still for radiation therapy.I am following the required birth control measures.My blood counts and liver function are within safe ranges, and I'm not on dialysis.I do not have severe health issues that could interfere with the treatment.
Research Study Groups:
This trial has the following groups:- Group 1: CPI-613® (Dose level -1.0 250 mg/m^2)
- Group 2: CPI-613® (Dose level 1.0 500 mg/m^2)
- Group 3: CPI-613® (Dose level 2.0 1,000 mg/m^2)
- Group 4: CPI-613® (Dose level 3.0 1,500 mg/m^2)
- Group 5: CPI-613® Maximum Tolerated Dose (MTD)
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.
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