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NCT03008408 · ClinicalTrials.gov registry record · Phase 2
A Phase II, Two-Arm Study of Everolimus and Letrozole, +/- Ribociclib (Lee011) in Patients With Advanced or Recurrent Endometrial Carcinoma
A Phase 2 study of Recurrent Endometrial Carcinoma and Recurrent Endometrial Endometrioid Adenocarcinoma, sponsored by M.D. Anderson Cancer Center.
- Active
- Registry status
- Phase 2
- Development phase
- 90
- Enrollment target
- 2
- Study locations
NCT03008408: Active Phase 2 study of Recurrent Endometrial Carcinoma and Recurrent Endometrial Endometrioid Adenocarcinoma, sponsored by M.D. Anderson Cancer Center.
NCT03008408 is a Phase 2 study of Recurrent Endometrial Carcinoma and Recurrent Endometrial Endometrioid Adenocarcinoma that is active but no longer recruiting, run by M.D. Anderson Cancer Center. The registered enrollment target is 90 participants, below the 248-participant average among 19 other Recurrent Endometrial Carcinoma trials with a reported enrollment target (64% lower). The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03008408, a Phase 2 study of Recurrent Endometrial Carcinoma and Recurrent Endometrial Endometrioid Adenocarcinoma, is active but no longer recruiting, sponsored by M.D. Anderson Cancer Center.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 90 participants
- Enrollment target
- 2
- Study locations
Study Summary
This phase II trial studies how well everolimus and letrozole with or without ribociclib work in treating participants with endometrial cancer that has spread to other areas of the body or has come back. Ribociclib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs such as everolimus and letrozole have been shown to be effective at stopping tumor growth either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving ribociclib, everolimus, and letrozole may work better than everolimus and letrozole in treating participants with endometrial cancer.
Primary Outcome
Per Response Evaluation Criteria in Solid Tumors version 1.1. This will be determined by combining the complete response rate, partial response rate, and stable disease rate. Response will be evaluated by repeat imaging (computed tomography or magnetic resonance imaging). Fisher's exact test will be used to compare patients with/without CTNNB1 mutation with respect to CBR.
Conditions Studied
Interventions
- DRUG Letrozole
- DRUG Everolimus
- DRUG Ribociclib
Study Locations (2)
Texas
- Lyndon Baines Johnson General Hospital - Houston
- M D Anderson Cancer Center - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 90 participants |
| Start Date | 2017-08-18 |
| Est. Completion | 2028-08-31 |
| Phase | Phase 2 |
What the registry record for NCT03008408 still lists
NCT03008408 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 90 participants, a relatively small participant target, below the 248-participant average among 19 other Recurrent Endometrial Carcinoma trials with a reported enrollment target (64% lower).
The record links to 10 conditions, with Recurrent Endometrial Carcinoma appearing as the primary indexed condition, and to 3 interventions - of which Letrozole is the first listed.
NCT03008408 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT03008408 about?
NCT03008408 is a clinical study titled "A Phase II, Two-Arm Study of Everolimus and Letrozole, +/- Ribociclib (Lee011) in Patients With Advanced or Recurrent Endometrial Carcinoma". This phase II trial studies how well everolimus and letrozole with or without ribociclib work in treating participants with endometrial cancer that has spread to other areas of the body or has come back. Ribociclib may stop the growth of tumor cells by blocking some of the enzymes needed for cell gr...
What is the current status of trial NCT03008408?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 90 participants. The study started on 2017-08-18. Estimated completion is 2028-08-31.
What conditions does trial NCT03008408 study?
This clinical trial studies the following conditions: Recurrent Endometrial Carcinoma, Recurrent Endometrial Endometrioid Adenocarcinoma, Refractory Endometrial Carcinoma, Refractory Endometrial Endometrioid Adenocarcinoma, Stage III Uterine Corpus Cancer AJCC v8.
What interventions are being tested in trial NCT03008408?
The interventions under investigation include: Letrozole (DRUG), Everolimus (DRUG), Ribociclib (DRUG).
Who is sponsoring clinical trial NCT03008408?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03008408 being conducted?
This trial has 2 study locations across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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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 NCT03008408's enrollment target sits among peer trials
90 5th of 19 higher than 15 of 19 other Recurrent Endometrial Carcinoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Recurrent Endometrial Carcinoma 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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