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NCT05733000 · ClinicalTrials.gov registry record · Phase 2
CPI-613 (Devimistat) in Combination With Hydroxychloroquine and 5-fluorouracil or Gemcitabine in Treating Patients With Advanced Chemorefractory Solid Tumors
A Phase 2 study of Advanced Malignant Solid Neoplasm and Clinical Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8, sponsored by Northwestern University.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 94
- Enrollment target
- 1
- Study location
NCT05733000 is a Phase 2 study of Advanced Malignant Solid Neoplasm and Clinical Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8 that is actively recruiting participants, run by Northwestern University. The registered enrollment target is 94 participants, below the 176-participant average among 108 other Advanced Malignant Solid Neoplasm trials with a reported enrollment target (47% lower). The trial reports 1 study location across 1 state.
The verdict
NCT05733000, a Phase 2 study of Advanced Malignant Solid Neoplasm and Clinical Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8, is actively recruiting participants, sponsored by Northwestern University.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 94 participants
- Enrollment target
- 1
- Study location
Study 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 Studied
Interventions
- PROCEDURE Biospecimen Collection
- PROCEDURE Computed Tomography
- DRUG Fluorouracil
- DRUG Devimistat
- DRUG Gemcitabine Hydrochloride
Study Locations (1)
Illinois
- Northwestern University - Chicago
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 94 participants |
| Start Date | 2023-03-08 |
| Est. Completion | 2030-03-04 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05733000
The ClinicalTrials.gov registry entry for NCT05733000 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 94 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 176-participant average among 108 other Advanced Malignant Solid Neoplasm trials with a reported enrollment target (47% lower). The listed sponsor is Northwestern University, which has 1,209 total studies on file at ClinicalTrials.gov.
The record links to 10 conditions, with Advanced Malignant Solid Neoplasm appearing as the primary indexed condition, and to 5 interventions - of which Biospecimen Collection is the first listed.
NCT05733000 reports 1 study location spanning 1 distinct geographic area - top geographies include Illinois.
Frequently Asked Questions
What is clinical trial NCT05733000 about?
NCT05733000 is a clinical study titled "CPI-613 (Devimistat) in Combination With Hydroxychloroquine and 5-fluorouracil or Gemcitabine in Treating Patients With Advanced Chemorefractory Solid Tumors". 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) ...
What is the current status of trial NCT05733000?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 94 participants. The study started on 2023-03-08. Estimated completion is 2030-03-04.
What conditions does trial NCT05733000 study?
This clinical trial studies the following conditions: Advanced Malignant Solid Neoplasm, Clinical Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8, Clinical Stage IV Gastroesophageal Junction Adenocarcinoma AJCC v8, Advanced Ovarian Carcinoma, Advanced Colorectal Carcinoma.
What interventions are being tested in trial NCT05733000?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Computed Tomography (PROCEDURE), Fluorouracil (DRUG), Devimistat (DRUG), Gemcitabine Hydrochloride (DRUG).
Who is sponsoring clinical trial NCT05733000?
This trial is sponsored by Northwestern University, which has 1,209 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05733000 being conducted?
This trial has 1 study location across Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Advanced Malignant Solid Neoplasm
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Clinical Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8
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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.