RecruitingPhase 2NCT05733000

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

Phase II Open-Label Multi-Cohort Study Evaluating CPI-613 (Devimistat) in Combination With Hydroxychloroquine and 5-fluorouracil or Gemcitabine in Patients With Advanced Chemorefractory Colorectal, Pancreatic, or Other Solid Cancers


Sponsor

Northwestern University

Enrollment

94 participants

Start Date

Mar 8, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

This phase II trial tests how well CPI-613 (devimistat) in combination with hydroxychloroquine (HCQ) and 5-fluorouracil (5-FU) or gemcitabine works in patients with solid tumors that may have spread from where they first started to nearby tissue, lymph nodes, or distant parts of the body (advanced) or that have not responded to chemotherapy medications (chemorefractory). Metabolism is how the cells in the body use molecules (carbohydrates, fats, and proteins) from food to get the energy they need to grow, reproduce and stay healthy. Tumor cells, however, do this process differently as they use more molecules (glucose, a type of carbohydrate) to make the energy they need to grow and spread. CPI-613 works by blocking the creation of the energy that tumor cells need to survive, grow in the body and make more tumor cells. When the energy production they need is blocked, the tumor cells can no longer survive. Hydroxychloroquine is a drug used to treat malaria and rheumatoid arthritis and may also improve the immune system in a way that tumors may be better controlled. Fluorouracil is in a class of medications called antimetabolites. It works by killing fast-growing abnormal cells. Gemcitabine is a chemotherapy drug that blocks the cells from making DNA and may kill tumor cells. CPI-613 (devimistat) in combination with hydroxychloroquine and 5-fluorouracil or gemcitabine may work to better treat advanced solid tumors.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial tests a combination of experimental treatments — CPI-613 (devimistat), hydroxychloroquine, and either 5-fluorouracil or gemcitabine — in people with advanced cancers that are no longer responding to standard treatment. CPI-613 targets how cancer cells produce energy. The trial includes separate groups for colorectal cancer, pancreatic cancer, and several other cancer types (biliary, gastroesophageal, urothelial, ovarian, and lung adenocarcinoma). **You may be eligible if...** - You are 18 or older with a confirmed diagnosis of one of the cancer types listed above - Your cancer is advanced/metastatic and standard treatments are no longer working - Your cancer is measurable on scans - You are in good enough health to participate (ECOG 0 or 1, occasionally 2 with approval) - You have adequate blood counts, liver, and kidney function **You may NOT be eligible if...** - You have brain metastases causing symptoms and currently on steroids - You have had a heart attack within the past 90 days - You have severe lung disease or uncontrolled heart problems - You have pre-existing retinal eye disease - You have poorly controlled diabetes - You are pregnant or breastfeeding - You have a known allergy to hydroxychloroquine or quinine compounds - You are unable to swallow oral medications Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREBiospecimen Collection

Undergo blood sample collection

PROCEDUREComputed Tomography

Undergo CT

DRUGDevimistat

Receive IV

DRUGFluorouracil

Receive IV

DRUGGemcitabine Hydrochloride

Receive IV

DRUGHydroxychloroquine

Receive PO

PROCEDUREMagnetic Resonance Imaging

Undergo MRI


Locations(1)

Northwestern University

Chicago, Illinois, United States

View Full Details on ClinicalTrials.gov

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NCT05733000


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