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

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.

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

Interventions

PROCEDURE

Biospecimen Collection

Undergo blood sample collection

PROCEDURE

Computed Tomography

Undergo CT

DRUG

Devimistat

Receive IV

DRUG

Fluorouracil

Receive IV

DRUG

Gemcitabine Hydrochloride

Receive IV

DRUG

Hydroxychloroquine

Receive PO

PROCEDURE

Magnetic Resonance Imaging

Undergo MRI

Sponsors & Collaborators

• National Cancer Institute (NCI)

  collaborator NIH

• Northwestern University

  lead OTHER

Principal Investigators

• Devalingam Mahalingam · Northwestern University

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-03-08

Primary Completion

2028-01-04

Completion

2030-03-04

FDA Drug

Yes

Countries

• United States

Study Locations