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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
Must not have
Patients who are unable to swallow or retain and absorb oral medication
Patients with poorly controlled diabetes mellitus
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

Summary

This trial tests a combination of three drugs to treat patients with advanced solid tumors that have spread or are resistant to previous treatments. The drugs work together to block energy production in tumor cells, boost the immune system, and kill fast-growing tumor cells. The goal is to see how well this combination works and how safe it is for patients.

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.
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.
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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I cannot swallow or properly absorb pills.
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My diabetes is not well-managed.
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I have a pre-existing eye condition affecting my retina.
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I am using corticosteroids for my brain metastases symptoms.
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I am taking medication that affects my heart's electrical cycle.
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I do not have any unmanaged ongoing illnesses.
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I have severe lung disease.
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I have certain heart conditions or ECG abnormalities.
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I started low dose chemotherapy with radiation less than 3 weeks ago.

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)
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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Overall response rate (ORR)
Secondary study objectives
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 3
~2020
Computed Tomography
2017
Completed Phase 2
~2740
Fluorouracil
2014
Completed Phase 3
~11700
Gemcitabine Hydrochloride
2005
Completed Phase 3
~5420
Hydroxychloroquine
2017
Completed Phase 4
~5360
Magnetic Resonance Imaging
2017
Completed Phase 3
~1160

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for Gastroesophageal Junction (GEJ) Adenocarcinoma, such as CPI-613 (devimistat), work by inhibiting metabolic pathways essential for tumor cell energy production, effectively starving the cancer cells. Other treatments like 5-fluorouracil (5-FU) and gemcitabine disrupt DNA synthesis, leading to cell death. Combining these with agents like hydroxychloroquine, which may enhance immune response, provides a comprehensive approach to combat the cancer. Understanding these mechanisms is crucial for GEJ Adenocarcinoma patients as it underscores the strategic targeting of cancer cell survival pathways to improve treatment efficacy and patient outcomes.

Find a Location

Who is running the clinical trial?

Northwestern UniversityLead Sponsor
1,630 Previous Clinical Trials
958,191 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,872 Previous Clinical Trials
41,012,770 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
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