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NCT01935973 · ClinicalTrials.gov registry record · Phase 1
Trametinib With or Without GSK2141795 in Treating Patients With Recurrent or Persistent Endometrial Cancer
A Phase 1 study of Endometrial Adenocarcinoma and Endometrial Serous Adenocarcinoma, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 1
- Development phase
- 26
- Enrollment target
- 20
- Study locations
NCT01935973: Completed Phase 1 study of Endometrial Adenocarcinoma and Endometrial Serous Adenocarcinoma, sponsored by National Cancer Institute (NCI).
NCT01935973 is a Phase 1 study of Endometrial Adenocarcinoma and Endometrial Serous Adenocarcinoma that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 26 participants, below the 338-participant average among 13 other Endometrial Adenocarcinoma trials with a reported enrollment target (92% lower). The trial reports 20 study locations across 15 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01935973, a Phase 1 study of Endometrial Adenocarcinoma and Endometrial Serous Adenocarcinoma, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 26 participants
- Enrollment target
- 20
- Study locations
Study Summary
This randomized phase I trial studies how well trametinib with or without GSK 2141795 (protein kinase B \[Akt\] inhibitor GSK2141795) works in treating patients with endometrial cancer that has come back (recurrent) or does not go to remission despite treatment (persistent). Trametinib and Akt inhibitor GSK2141795 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether trametinib is a more effective treatment for endometrial cancer when given with or without ATK inhibitor GSK2141795.
Primary Outcome
The null hypothesis will be tested against the alternative with a stratified log-rank test.
Conditions Studied
Interventions
- OTHER Laboratory Biomarker Analysis
- DRUG Trametinib
- DRUG Uprosertib
Study Locations (20)
Ohio
- Case Western Reserve University - Cleveland
- Cleveland Clinic Foundation - Cleveland
- Ohio State University Comprehensive Cancer Center - Columbus
- Hillcrest Hospital Cancer Center - Mayfield Heights
Connecticut
- Hartford Hospital - Hartford
- The Hospital of Central Connecticut - New Britain
Pennsylvania
- Thomas Jefferson University Hospital - Philadelphia
- Fox Chase Cancer Center - Philadelphia
Georgia
- Augusta University Medical Center - Augusta
Illinois
- University of Chicago Comprehensive Cancer Center - Chicago
Kentucky
- University of Kentucky/Markey Cancer Center - Lexington
Maryland
- Johns Hopkins University/Sidney Kimmel Cancer Center - Baltimore
Missouri
- Washington University School of Medicine - St Louis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 26 participants |
| Start Date | 2013-09-30 |
| Est. Completion | 2015-09-08 |
| Phase | Phase 1 |
What the finished NCT01935973 record still lists
NCT01935973 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 26 participants, a relatively small participant target, below the 338-participant average among 13 other Endometrial Adenocarcinoma trials with a reported enrollment target (92% lower).
The record links to 6 conditions, with Endometrial Adenocarcinoma appearing as the primary indexed condition, and to 3 interventions - of which Laboratory Biomarker Analysis is the first listed.
NCT01935973 names 20 study sites across 15 states, led by Ohio, Connecticut, Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT01935973 about?
NCT01935973 is a clinical study titled "Trametinib With or Without GSK2141795 in Treating Patients With Recurrent or Persistent Endometrial Cancer". This randomized phase I trial studies how well trametinib with or without GSK 2141795 (protein kinase B \[Akt\] inhibitor GSK2141795) works in treating patients with endometrial cancer that has come back (recurrent) or does not go to remission despite treatment (persistent). Trametinib and Akt inhib...
What is the current status of trial NCT01935973?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 26 participants. The study started on 2013-09-30. Estimated completion is 2015-09-08.
What conditions does trial NCT01935973 study?
This clinical trial studies the following conditions: Endometrial Adenocarcinoma, Endometrial Serous Adenocarcinoma, Endometrial Clear Cell Adenocarcinoma, Endometrial Mixed Cell Adenocarcinoma, Endometrial Undifferentiated Carcinoma.
What interventions are being tested in trial NCT01935973?
The interventions under investigation include: Laboratory Biomarker Analysis (OTHER), Trametinib (DRUG), Uprosertib (DRUG).
Who is sponsoring clinical trial NCT01935973?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01935973 being conducted?
This trial has 20 study locations across Connecticut, Georgia, Illinois, Kentucky, Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Endometrial Adenocarcinoma
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 NCT01935973's enrollment target sits among peer trials
26 13th of 13 higher than 1 of 13 other Endometrial Adenocarcinoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Endometrial 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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