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NCT04494113 · ClinicalTrials.gov registry record · Early Phase 1
Testing the Response to the Anti-cancer Drug, Triapine, in Uterine Cancers Using Markers From the Tissue at the Time of Hysterectomy
A Early Phase 1 study of Endometrial Serous Adenocarcinoma, sponsored by National Cancer Institute (NCI).
- Active
- Registry status
- Early Phase 1
- Development phase
- 12
- Enrollment target
- 7
- Study locations
NCT04494113: Active Early Phase 1 study of Endometrial Serous Adenocarcinoma, sponsored by National Cancer Institute (NCI).
NCT04494113 is a Early Phase 1 study of Endometrial Serous Adenocarcinoma that is active but no longer recruiting, run by National Cancer Institute (NCI). The registered enrollment target is 12 participants, below the 301-participant average among 12 other Endometrial Serous Adenocarcinoma trials with a reported enrollment target (96% lower). The trial reports 7 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04494113, a Early Phase 1 study of Endometrial Serous Adenocarcinoma, is active but no longer recruiting, sponsored by National Cancer Institute (NCI).
- ACTIVE NOT RECRUITING
- Registry status
- Early Phase 1
- Development phase
- 12 participants
- Enrollment target
- 7
- Study locations
Study Summary
This early phase I trial investigates the response to the anti-cancer drug, triapine, in uterine cancers by using markers from tissue samples at the time of removal of the uterus, ovaries, and fallopian tubes (hysterectomy and bilateral salpingo-oophorectomy). Triapine may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Adding triapine to the usual approach of surgery followed by chemotherapy alone or in combination with radiation therapy may help to slow the growth of uterine cancer.
Primary Outcome
Pharmacodynamic response rate will be estimated as the proportion of evaluable patients who achieve pharmacodynamic response defined as a decrease in phospho-histone H3 immunoscore of \>= 1 from baseline to post-exposure of intravenous triapine for each patient. The corresponding 95% confidence interval will be provided.
Conditions Studied
Interventions
- PROCEDURE Biospecimen Collection
- PROCEDURE Biopsy Procedure
- PROCEDURE Resection
- DRUG Triapine
Study Locations (7)
Florida
- UM Sylvester Comprehensive Cancer Center at Coral Gables - Coral Gables
- UM Sylvester Comprehensive Cancer Center at Deerfield Beach - Deerfield Beach
- University of Miami Miller School of Medicine-Sylvester Cancer Center - Miami
- UM Sylvester Comprehensive Cancer Center at Plantation - Plantation
Maryland
- Johns Hopkins University/Sidney Kimmel Cancer Center - Baltimore
Pennsylvania
- Thomas Jefferson University Hospital - Philadelphia
Virginia
- VCU Massey Comprehensive Cancer Center - Richmond
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2022-02-08 |
| Est. Completion | 2026-06-01 |
| Phase | Early Phase 1 |
What the registry record for NCT04494113 still lists
NCT04494113 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 301-participant average among 12 other Endometrial Serous Adenocarcinoma trials with a reported enrollment target (96% lower).
The record links to 1 condition, with Endometrial Serous Adenocarcinoma appearing as the primary indexed condition, and to 4 interventions - of which Biospecimen Collection is the first listed.
NCT04494113 lists 7 locations in 4 states (Florida, Maryland, Pennsylvania).
Frequently Asked Questions
What is clinical trial NCT04494113 about?
NCT04494113 is a clinical study titled "Testing the Response to the Anti-cancer Drug, Triapine, in Uterine Cancers Using Markers From the Tissue at the Time of Hysterectomy". This early phase I trial investigates the response to the anti-cancer drug, triapine, in uterine cancers by using markers from tissue samples at the time of removal of the uterus, ovaries, and fallopian tubes (hysterectomy and bilateral salpingo-oophorectomy). Triapine may stop the growth of tumor c...
What is the current status of trial NCT04494113?
This trial is currently active not recruiting. It is a Early Phase 1 study. The enrollment target is 12 participants. The study started on 2022-02-08. Estimated completion is 2026-06-01.
What conditions does trial NCT04494113 study?
This clinical trial studies the following conditions: Endometrial Serous Adenocarcinoma.
What interventions are being tested in trial NCT04494113?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Biopsy Procedure (PROCEDURE), Resection (PROCEDURE), Triapine (DRUG).
Who is sponsoring clinical trial NCT04494113?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04494113 being conducted?
This trial has 7 study locations across Florida, Maryland, Pennsylvania, Virginia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04494113's enrollment target sits among peer trials
12 13th of 12 the lowest of 12 other Endometrial Serous Adenocarcinoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Endometrial Serous Adenocarcinoma 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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