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

Part of paid clinical trials in Chicago, Illinois.

Sponsor
Northwestern University
Study ID
NCT05733000
Phase
PHASE2
Status
Recruiting
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Conditions

  • Advanced Biliary Tract Carcinoma
  • Advanced Colorectal Carcinoma
  • Advanced Gastroesophageal Junction Adenocarcinoma
  • Advanced Lung Adenocarcinoma
  • Advanced Malignant Solid Neoplasm
  • Advanced Ovarian Carcinoma
  • Advanced Pancreatic Carcinoma
  • Advanced Urothelial Carcinoma
  • Clinical Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8
  • Clinical Stage IV Gastroesophageal Junction Adenocarcinoma AJCC v8
  • Metastatic Biliary Tract Carcinoma
  • Metastatic Colorectal Carcinoma
  • Metastatic Gastroesophageal Junction Adenocarcinoma
  • Metastatic Lung Adenocarcinoma
  • Metastatic Ovarian Carcinoma
  • Metastatic Pancreatic Carcinoma
  • Metastatic Urothelial Carcinoma
  • Refractory Biliary Tract Carcinoma
  • Refractory Colorectal Carcinoma
  • Refractory Gastroesophageal Junction Adenocarcinoma
  • Refractory Lung Adenocarcinoma
  • Refractory Ovarian Carcinoma
  • Refractory Pancreatic Carcinoma
  • Refractory Urothelial Carcinoma
  • Stage II Pancreatic Cancer AJCC v8
  • Stage III Colorectal Cancer AJCC v8
  • Stage III Lung Cancer AJCC v8
  • Stage III Ovarian Cancer AJCC v8
  • Stage III Pancreatic Cancer AJCC v8
  • Stage IV Colorectal Cancer AJCC v8
  • Stage IV Lung Cancer AJCC v8
  • Stage IV Ovarian Cancer AJCC v8
  • Stage IV Pancreatic Cancer AJCC v8

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Biospecimen Collection — PROCEDURE
    Undergo blood sample collection
  • Computed Tomography — PROCEDURE
    Undergo CT
  • Devimistat — DRUG
    Receive IV
  • Fluorouracil — DRUG
    Receive IV
  • Gemcitabine Hydrochloride — DRUG
    Receive IV
  • Hydroxychloroquine — DRUG
    Receive PO
  • Magnetic Resonance Imaging — PROCEDURE
    Undergo MRI

Study Details

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.

Key Dates

Start date
Mar 8, 2023
Status verified
Feb 2023
Primary completion
Jan 4, 2028
Completion
Mar 4, 2030

Study Design

Enrollment
94 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: COHORT 1 (Devimistat, 5-FU, HCQ)
    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.
  • Experimental: COHORT 2 (Devimistat, 5-FU, HCQ)
    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.
  • Experimental: COHORT 3 (Devimistat, 5-FU, HCQ, Gemcitabine)
    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.

Primary Outcome Measure

Overall response rate (ORR) [ Time Frame: Time from baseline to disease progression, initiates subsequent anti-cancer therapy, or 24 months (whichever occurs first) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Northwestern UniversityChicagoIllinois60611
Devalingam Mahalingam, MD, PhD
[email protected]
312-695-6929
Devalingam Mahalingam, MD, PhD (PRINCIPAL_INVESTIGATOR)

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By research site
Northwestern University· Chicago, IL

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