CPI-613 (Devimistat) in Combination With Hydroxychloroquine and 5-fluorouracil or Gemcitabine in Treating Patients With Advanced Chemorefractory Solid Tumors
Public ClinicalTrials.gov record NCT05733000. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT05733000
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 94 participants
Conditions and interventions
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
- Biospecimen Collection Procedure
- Computed Tomography Procedure
- Devimistat Drug
- Fluorouracil Drug
- Gemcitabine Hydrochloride Drug
- Hydroxychloroquine Drug
- Magnetic Resonance Imaging Procedure
Procedure · Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Mar 7, 2023
- Primary completion
- Jan 3, 2028
- Completion
- Mar 3, 2030
- Last update posted
- Mar 9, 2023
2023 – 2030
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Northwestern University | Chicago | Illinois | 60611 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05733000, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Mar 9, 2023 · Synced Sep 1, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT05733000 live on ClinicalTrials.gov.