Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01797523 · ClinicalTrials.gov registry record · Phase 2
A Phase II, Single-Arm Study of RAD001 (Everolimus), Letrozole, and Metformin in Patients With Advanced or Recurrent Endometrial Carcinoma
A Phase 2 study of Endometrial Cancer, sponsored by M.D. Anderson Cancer Center.
- Active
- Registry status
- Phase 2
- Development phase
- 62
- Enrollment target
- 6
- Study locations
NCT01797523: Active Phase 2 study of Endometrial Cancer, sponsored by M.D. Anderson Cancer Center.
NCT01797523 is a Phase 2 study of Endometrial Cancer that is active but no longer recruiting, run by M.D. Anderson Cancer Center. The registered enrollment target is 62 participants, below the 524-participant average among 181 other Endometrial Cancer trials with a reported enrollment target (88% lower). The trial reports 6 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01797523, a Phase 2 study of Endometrial Cancer, is active but no longer recruiting, sponsored by M.D. Anderson Cancer Center.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 62 participants
- Enrollment target
- 6
- Study locations
Study Summary
The goal of this clinical research study is to learn if the combination of everolimus, letrozole, and metformin can help to control recurrent or progressive endometrial cancer. The safety of this drug combination will also be studied. Everolimus is designed to block a protein inside cancer cells that is involved in cancer growth. Letrozole is designed to block a protein from making estrogen. This may interfere with the growth of cancer cells. Metformin is commonly used to control blood sugar levels in patients with diabetes. It is designed to lower insulin levels, which may slow or stop the growth of endometrial cancer cells.
Primary Outcome
The proportion of patients demonstrating a clinical benefit (CBR) complete response + partial response + stable disease rates) based on RECIST v1.1.
Conditions Studied
Interventions
- DRUG Letrozole
- DRUG Everolimus
- DRUG Metformin
Study Locations (6)
Texas
- Memorial City Medical Center - Houston
- Lyndon B Johnson General Hospital - Houston
- University of Texas MD Anderson Cancer Center - Houston
- The Woman's Hospital of Texas - Houston
Florida
- Sacred Heart Health Systems - Pensacola
New Jersey
- MD Anderson Cooper Cancer Center - Voorhees Township
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 62 participants |
| Start Date | 2013-10-07 |
| Est. Completion | 2027-10-31 |
| Phase | Phase 2 |
What the registry record for NCT01797523 still lists
NCT01797523 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 62 participants, a relatively small participant target, below the 524-participant average among 181 other Endometrial Cancer trials with a reported enrollment target (88% lower).
The record links to 1 condition, with Endometrial Cancer appearing as the primary indexed condition, and to 3 interventions - of which Letrozole is the first listed.
NCT01797523 lists 6 locations in 3 states (Texas, Florida, New Jersey).
Frequently Asked Questions
What is clinical trial NCT01797523 about?
NCT01797523 is a clinical study titled "A Phase II, Single-Arm Study of RAD001 (Everolimus), Letrozole, and Metformin in Patients With Advanced or Recurrent Endometrial Carcinoma". The goal of this clinical research study is to learn if the combination of everolimus, letrozole, and metformin can help to control recurrent or progressive endometrial cancer. The safety of this drug combination will also be studied. Everolimus is designed to block a protein inside cancer cells th...
What is the current status of trial NCT01797523?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 62 participants. The study started on 2013-10-07. Estimated completion is 2027-10-31.
What conditions does trial NCT01797523 study?
This clinical trial studies the following conditions: Endometrial Cancer.
What interventions are being tested in trial NCT01797523?
The interventions under investigation include: Letrozole (DRUG), Everolimus (DRUG), Metformin (DRUG).
Who is sponsoring clinical trial NCT01797523?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01797523 being conducted?
This trial has 6 study locations across Florida, New Jersey, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Endometrial Cancer
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 NCT01797523's enrollment target sits among peer trials
62 114th of 181 higher than 67 of 181 other Endometrial Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Endometrial Cancer 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.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Adjuvant Therapy in POLE-Mutated and p53-Wildtype/NSMP Early Stage Endometrial Cancer RAINBO BLUE & TAPER
RECRUITING · Phase 2
-
A Study of Lifileucel (Tumor-infiltrating Lymphocytes) in Adults With Advanced Endometrial Cancer.
RECRUITING · Phase 2
-
Radiation and TSR-042 (Dostarlimab) in People With Endometrial Cancer After They Receive Surgery
RECRUITING · Phase 2
-
Sapanisertib and Serabelisib (PIKTOR) With Paclitaxel and a Substudy With an Insulin-Suppressing Diet in Patients With Advanced/Recurrent Endometrial Cancer
RECRUITING · Phase 2
-
Evaluation of Mirvetuximab Soravtansine (IMGN853) in Women With Folate Receptor-α Positive Endometrial Cancer
RECRUITING · Phase 2
-
Relacorilant in Combination With Different Treatment Regimens in Patients With Gynecological Cancers
RECRUITING · Phase 2
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT03231150 · 62 participants · NA
Plantar Fasciitis Randomized Clinical Control Trial
- NCT03458676 · 62 participants · NA
Radiologic Pathologic Correlation of Advanced MR Imaging to Guide the Biopsy of Cerebral Malignancies
- NCT03596086 · 62 participants · Phase 1
HSV-tk + Valacyclovir + SBRT + Chemotherapy for Recurrent GBM
- NCT03603405 · 62 participants · Phase 1
HSV-tk and XRT and Chemotherapy for Newly Diagnosed GBM
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI