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Metabolic Inhibitor

Devimistat Combo for Advanced Cancers

Phase 2

Recruiting

Led By Devalingam Mahalingam

Research Sponsored by Northwestern University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients must meet specified renal function criteria

Patients must be age >= 18 years

Timeline

Screening 3 weeks

Treatment Varies

Follow Up time from baseline to disease progression, initiates subsequent anti-cancer therapy, or 24 months (whichever occurs first)

Awards & highlights

Study Summary

This trial tests a combo of drugs to better treat advanced solid tumors. It blocks energy production tumor cells need & may kill them.

Who is the study for?

This trial is for adults with advanced solid tumors like colorectal, pancreatic, biliary, gastroesophageal, urothelial, ovarian or lung cancer (adenocarcinoma only) that haven't responded to standard treatments. Participants must have good physical function and meet specific blood count and organ function criteria. They should not be pregnant/nursing and must agree to use contraception if applicable.Check my eligibility

What is being tested?

The trial tests CPI-613 (devimistat) combined with hydroxychloroquine and either 5-fluorouracil or gemcitabine against advanced chemorefractory solid tumors. Devimistat targets the energy production of tumor cells while hydroxychloroquine may enhance immune response; both fluorouracil and gemcitabine are chemotherapy drugs aiming to kill fast-growing abnormal cells.See study design

What are the potential side effects?

Potential side effects include fatigue, nausea, diarrhea from chemotherapy drugs like fluorouracil and gemcitabine; devimistat might cause metabolic disturbances since it affects cell energy processes; hydroxychloroquine can lead to vision changes or muscle weakness.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My kidney function meets the required levels.

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I am 18 years old or older.

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I have pancreatic cancer.

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I have tried all targeted therapy options available for my condition.

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My liver is functioning within normal ranges.

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I am fully active or restricted in physically strenuous activity but can do light work.

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My cancer cannot be cured with standard treatments, or I cannot tolerate them.

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I have colorectal cancer.

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I had hepatitis C but have been successfully treated and cured.

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I have chronic hepatitis B but it's under control with medication.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ time from baseline to disease progression, initiates subsequent anti-cancer therapy, or 24 months (whichever occurs first)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~time from baseline to disease progression, initiates subsequent anti-cancer therapy, or 24 months (whichever occurs first)

This trial's timeline: 3 weeks for screening, Varies for treatment, and time from baseline to disease progression, initiates subsequent anti-cancer therapy, or 24 months (whichever occurs first) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Overall response rate (ORR)

Secondary outcome measures

Duration of response (DOR)

Incidence of adverse events

Overall survival (OS)

+1 more

Trial Design

3Treatment groups

Experimental Treatment

Group I: COHORT 3 (Devimistat, 5-FU, HCQ, Gemcitabine)Experimental Treatment7 Interventions

Patients with gastroesophageal cancer receive devimistat IV, 5-FU IV, plus HCQ PO on study. Patients with urothelial, ovarian, or non-small cell lung cancer receive devimistat IV, gemcitabine IV, plus HCQ PO on study. Patients with biliary tumors receive devimistat IV and gemcitabine IV or HCQ PO on study. Patients also undergo CT and/or MRI and undergo blood specimen collection throughout the study.

Group II: COHORT 2 (Devimistat, 5-FU, HCQ)Experimental Treatment6 Interventions

Patients with pancreatic cancer receive devimistat IV, 5-FU IV, plus HCQ PO on study. Patients also undergo CT and/or MRI and undergo blood specimen collection throughout the study.

Group III: COHORT 1 (Devimistat, 5-FU, HCQ)Experimental Treatment6 Interventions

Patients with colorectal cancer receive devimistat IV, 5-FU IV, plus HCQ PO on study. Patients also undergo CT and/or MRI and undergo blood specimen collection throughout the study.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Biospecimen Collection

2004

Completed Phase 2

~1700

Computed Tomography

2017

Completed Phase 2

~2720

Fluorouracil

2014

Completed Phase 3

~11540

Gemcitabine Hydrochloride

2005

Completed Phase 3

~5420

Hydroxychloroquine

2017

Completed Phase 4

~5360

Magnetic Resonance Imaging

2017

Completed Phase 3

~1190

0 / 10Eligibility criteria met

Find a Location

Who is running the clinical trial?

Northwestern UniversityLead Sponsor

1,586 Previous Clinical Trials

916,925 Total Patients Enrolled

National Cancer Institute (NCI)NIH

13,664 Previous Clinical Trials

40,926,079 Total Patients Enrolled

Devalingam MahalingamPrincipal InvestigatorNorthwestern University

1 Previous Clinical Trials

17 Total Patients Enrolled

Media Library

CPI-613 (Devimistat) (Metabolic Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05733000 — Phase 2

Gastroesophageal Junction Adenocarcinoma Research Study Groups: COHORT 1 (Devimistat, 5-FU, HCQ), COHORT 2 (Devimistat, 5-FU, HCQ), COHORT 3 (Devimistat, 5-FU, HCQ, Gemcitabine)

Gastroesophageal Junction Adenocarcinoma Clinical Trial 2023: CPI-613 (Devimistat) Highlights & Side Effects. Trial Name: NCT05733000 — Phase 2

CPI-613 (Devimistat) (Metabolic Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05733000 — Phase 2

Frequently Asked Questions

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

What deleterious effects may arise from the utilization of Devimistat, 5-FU, and HCQ (COHORT 1)?

"Due to the fact it is a Phase 2 trial, with some preliminary safety data but none in regards to efficacy, our team at Power have rated the security of COHORT 1 (Devimistat, 5-FU, HCQ) as an intermediate level 2."

Answered by AI

Are participants being actively enrolled in this investigation?

"According to information from clinicaltrials.gov, this trial is no longer enrolling patients as of February 6th 2023. Since then, it has been superseded by over six thousand other studies that are actively seeking participants."

Answered by AI

Who else is applying?

What site did they apply to?

Northwestern University

What portion of applicants met pre-screening criteria?

Did not meet criteria

Why did patients apply to this trial?

I have Stage IV esophageal cancer. I have been told that surgery to remove the tumor is not an option. I have tried two different series of chemotherapy drugs along with radiation and am looking for other treatment options that might be available.

PatientReceived 1 prior treatment

Recent research and studies

clinicaltrials.govStudy

CPI-613 (Devimistat) in Combination With Hydroxychloroquine and 5-fluorouracil or Gemcitabine in Treating Patients With Advanced Chemorefractory Solid Tumors

2023. "CPI-613 (Devimistat) in Combination With Hydroxychloroquine and 5-fluorouracil or Gemcitabine in Treating Patients With Advanced Chemorefractory Solid Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05733000.

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