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NCT03366116 · ClinicalTrials.gov registry record · Phase 1
5-aza-4'-Thio-2'-Deoxycytidine (Aza-TdC) in People With Advanced Solid Tumors
A Phase 1 study of Neoplasms and Solid Tumors, sponsored by National Cancer Institute (NCI).
- Recruiting
- Registry status
- Phase 1
- Development phase
- 65
- Enrollment target
- 1
- Study location
NCT03366116: Recruiting Phase 1 study of Neoplasms and Solid Tumors, sponsored by National Cancer Institute (NCI).
NCT03366116 is a Phase 1 study of Neoplasms and Solid Tumors that is actively recruiting participants, run by National Cancer Institute (NCI). The registered enrollment target is 65 participants, below the 1,621-participant average among 158 other Neoplasms trials with a reported enrollment target (96% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03366116, a Phase 1 study of Neoplasms and Solid Tumors, is actively recruiting participants, sponsored by National Cancer Institute (NCI).
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 65 participants
- Enrollment target
- 1
- Study location
Study Summary
Background: Blood, tissue, and tumor cells contain genes. Genes are made up of DNA. DNA is the "instruction book" for each cell. In some people with cancer, the genes that might have slowed the growth of their tumor were "turned off." Researchers want to see if a new drug can turn the genes back on and slow the tumor growth. The drug is called Aza-TdC. Objective: To test the safety of Aza-TdC, and to find out the dose of this drug that can be safely given to humans. Eligibility: People ages 18 and older who have advanced cancer that has gotten worse after standard treatment, or for which no effective therapy exists Design: Participants will be screened with: Medical history Blood and urine tests Scans to measure their tumors Test to measure the electrical activity of the heart Participants will take the study drug by mouth. The drug is given in cycles. Each cycle is 21 days (3 weeks) long. Week 1 and week 2: participants will take the study drug once a day for 5 days. Then they will have 2 days without the drug. Week 3: no study drug is taken. This completes one cycle of treatment. For cycle 1, participants will repeat the screening tests several times. For all other cycles, participants will have blood tests and pregnancy tests. They will have scans of their tumor every 6 weeks. The cycle will be repeated as long as the participant tolerates the drug and the cancer is either stable or gets better. Sponsoring Institute: National Cancer Institute ...
Primary Outcome
To determine the safety, tolerability, and MTD of oral aza-TdC administered daily for 5 days a week for 2 weeks, with one week off, in 21-day cycles
Conditions Studied
Interventions
- DRUG aza-TdC
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 65 participants |
| Start Date | 2018-11-05 |
| Est. Completion | 2026-09-30 |
| Phase | Phase 1 |
What NCT03366116 shows while recruiting
NCT03366116 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 65 participants, a relatively small participant target, below the 1,621-participant average among 158 other Neoplasms trials with a reported enrollment target (96% lower).
The record links to 2 conditions, with Neoplasms appearing as the primary indexed condition, and to 1 intervention - of which aza-TdC is the first listed.
NCT03366116 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT03366116 about?
NCT03366116 is a clinical study titled "5-aza-4'-Thio-2'-Deoxycytidine (Aza-TdC) in People With Advanced Solid Tumors". Background: Blood, tissue, and tumor cells contain genes. Genes are made up of DNA. DNA is the "instruction book" for each cell. In some people with cancer, the genes that might have slowed the growth of their tumor were "turned off." Researchers want to see if a new drug can turn the genes back on...
What is the current status of trial NCT03366116?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 65 participants. The study started on 2018-11-05. Estimated completion is 2026-09-30.
What conditions does trial NCT03366116 study?
This clinical trial studies the following conditions: Neoplasms, Solid Tumors.
What interventions are being tested in trial NCT03366116?
The interventions under investigation include: aza-TdC (DRUG).
Who is sponsoring clinical trial NCT03366116?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03366116 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Neoplasms
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 NCT03366116's enrollment target sits among peer trials
65 91st of 158 higher than 68 of 158 other Neoplasms trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Neoplasms 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.
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