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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 below

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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

This trial's timeline: 3 weeks for screening, Varies for treatment, and initiation of treatment to 30 days after treatment for reporting.

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 • NCT01005680

51%

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

Blood sodium decreased

Hypokalaemia

Insomnia

Pyrexia

Hyponatraemia

Blood creatinine increased

Lymphopenia

Diarrhoea

Dyspepsia

Red blood cell count decreased

Cough

Dizziness

Bone marrow failure

Ischaemic stroke

Cerebral infarction

Dyspnoea

Pulmonary embolism

Embolism venous

Superior vena cava syndrome

100%

80%

60%

40%

20%

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

Group IV: CPI-613® (Dose level 1.0 500 mg/m^2)Experimental Treatment3 Interventions

Group V: CPI-613® (Dose level -1.0 250 mg/m^2)Experimental Treatment3 Interventions

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Gemcitabine

2017

Completed Phase 3

~2070

0 / 6Eligibility criteria met

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

609 Previous Clinical Trials

1,162,559 Total Patients Enrolled

Cornerstone PharmaceuticalsIndustry Sponsor

13 Previous Clinical Trials

837 Total Patients Enrolled

Media Library

CPI-613® (Enzyme Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05325281 — Phase 1

Pancreatic Adenocarcinoma Research Study Groups: CPI-613® (Dose level -1.0 250 mg/m^2), CPI-613® (Dose level 1.0 500 mg/m^2), CPI-613® (Dose level 2.0 1,000 mg/m^2), CPI-613® (Dose level 3.0 1,500 mg/m^2), CPI-613® Maximum Tolerated Dose (MTD)

Pancreatic Adenocarcinoma Clinical Trial 2023: CPI-613® Highlights & Side Effects. Trial Name: NCT05325281 — Phase 1

CPI-613® (Enzyme Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05325281 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the FDA sanctioned Gemcitabine for clinical use?

"Since there is only limited data regarding Gemcitabine's safety and efficacy, it was given a score of 1 on our team's metric."

Answered by AI

Are participants still being accepted for this medical investigation?

"Clinicaltrials.gov reveals that this clinical trial is still in the process of enrolment, with its original posting dated October 31st 2022 and most recent update on November 9th 2022."

Answered by AI

How many individuals are involved in the current clinical investigation?

"This is accurate. According to records on clinicaltrials.gov, this trial was first published on October 31st 2022 and has been updated recently as of November 9th 2022. The study requires 24 people from one location for participation."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

CPI-613 (Devimistat) in Combination With Chemoradiation in Patients With Pancreatic Adenocarcinoma

Mandana Kamgar, MD 2022. "CPI-613 (Devimistat) in Combination With Chemoradiation in Patients With Pancreatic Adenocarcinoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05325281.