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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: Recruiting Phase 2 study of Advanced Malignant Solid Neoplasm and Clinical Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8, sponsored by Northwestern University.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Will be assessed by Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1 in patients with solid tumors treated under this protocol. ORR is defined as the percentage of patients with documented complete response (CR) plus the percentage of patients with documented partial response (PR). ORR will be reported with the corresponding exact confidence intervals.
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 |
What NCT05733000 shows while recruiting
NCT05733000 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 94 participants, a relatively small participant target, below the 176-participant average among 108 other Advanced Malignant Solid Neoplasm trials with a reported enrollment target (47% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Advanced Malignant Solid Neoplasm
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05733000's enrollment target sits among peer trials
94 26th of 108 higher than 83 of 108 other Advanced Malignant Solid Neoplasm trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Advanced Malignant Solid Neoplasm trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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