Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT03233724 · ClinicalTrials.gov registry record · Phase 1
Oral Decitabine and Tetrahydrouridine as Epigenetic Priming for Pembrolizumab-Mediated Immune Checkpoint Blockade in Patients With Inoperable, or Unresectable Locally Advanced or Metastatic Non-Small Cell Lung Cancers and Esophageal Carcinomas
A Phase 1 study, sponsored by National Cancer Institute (NCI).
- Terminated
- Registry status
- Phase 1
- Development phase
- 9
- Enrollment target
NCT03233724: Clinical Trial Phase 1 study, sponsored by National Cancer Institute (NCI).
NCT03233724 is a Phase 1 study that was terminated before completion, run by National Cancer Institute (NCI). The registered enrollment target is 9 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03233724, a Phase 1 study, was terminated before completion, sponsored by National Cancer Institute (NCI).
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 9 participants
- Enrollment target
Study Summary
Background: Non-small cell lung cancer (NSCLC) is the most common type of lung cancer. Lung cancer is the leading cause of cancer-related death in the United States. Most people with lung cancer are already in the advanced stages of the disease by the time they see a doctor. Researchers want to see if combining an approved drug with two new drugs can help. Objective: To study if tetrahydrouridine-decitabine (THU-DAC) with pembrolizumab is safe and effective in people with non-small cell lung cancer that cannot be removed by surgery. Eligibility: People 18 years and older who have NSCLC that cannot be removed by surgery Design: Participants will be screened with * Medical history * Physical exam * Blood and urine tests * Tests of heart and lung function They may have a small tumor sample taken (biopsy). They may have tumor scans. Before starting treatment, participants will repeat the screening tests. They will also give a stool sample. The study will be done in 3-week cycles for up to 6 cycles. * Participants will take the 2 study drugs by mouth 3-5 days a week. * Participants will get pembrolizumab in a vein for 30 minutes 1 day each cycle. Participants will keep a study medication diary. During cycle 1, participants will have blood taken multiple times on days 1 and 2. Every 3 cycles, participants will repeat screening tests. Participants will have a mandatory tumor biopsy. When they finish treatment, participants will have a physical exam and blood tests.
Interventions
- DRUG Pembrolizumab
- DRUG Decitabine (DAC)
- DRUG Tetrahydrouridine (THU)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 9 participants |
| Start Date | 2018-04-11 |
| Est. Completion | 2021-10-26 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03233724
The ClinicalTrials.gov registry entry for NCT03233724 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 9 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Pembrolizumab is the first listed.
NCT03233724 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03233724 about?
NCT03233724 is a clinical study titled "Oral Decitabine and Tetrahydrouridine as Epigenetic Priming for Pembrolizumab-Mediated Immune Checkpoint Blockade in Patients With Inoperable, or Unresectable Locally Advanced or Metastatic Non-Small Cell Lung Cancers and Esophageal Carcinomas". Background: Non-small cell lung cancer (NSCLC) is the most common type of lung cancer. Lung cancer is the leading cause of cancer-related death in the United States. Most people with lung cancer are already in the advanced stages of the disease by the time they see a doctor. Researchers want to see...
What is the current status of trial NCT03233724?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 9 participants. The study started on 2018-04-11. Estimated completion is 2021-10-26.
What interventions are being tested in trial NCT03233724?
The interventions under investigation include: Pembrolizumab (DRUG), Decitabine (DAC) (DRUG), Tetrahydrouridine (THU) (DRUG).
Who is sponsoring clinical trial NCT03233724?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Related
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, the data changelog, or report a data error.