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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 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.

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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 ...

Conditions Studied

Interventions

  • DRUG aza-TdC

Study Locations (1)

Maryland

  • National Institutes of Health Clinical Center - Bethesda

Trial Details

FieldValue
Enrollment Target 65 participants
Start Date 2018-11-05
Est. Completion 2026-09-30
Phase Phase 1

Sponsor

National Cancer Institute (NCI)

3,257 total trials

What the Registry Record Tells You About NCT03366116

The ClinicalTrials.gov registry entry for NCT03366116 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 65 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,621-participant average among 158 other Neoplasms trials with a reported enrollment target (96% lower). The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.

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 1 study location spanning 1 distinct geographic area - top geographies include 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.

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