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NCT04719273 · ClinicalTrials.gov registry record · Phase 2
Onapristone and Anastrozole for the Treatment of Refractory Hormone Receptor Positive Endometrial Cancer
A Phase 2 study of Refractory Endometrial Carcinoma and Refractory Endometrial Endometrioid Adenocarcinoma, sponsored by Thomas Jefferson University.
- Active
- Registry status
- Phase 2
- Development phase
- 14
- Enrollment target
- 2
- Study locations
NCT04719273: Active Phase 2 study of Refractory Endometrial Carcinoma and Refractory Endometrial Endometrioid Adenocarcinoma, sponsored by Thomas Jefferson University.
NCT04719273 is a Phase 2 study of Refractory Endometrial Carcinoma and Refractory Endometrial Endometrioid Adenocarcinoma that is active but no longer recruiting, run by Thomas Jefferson University. The registered enrollment target is 14 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (89% lower). The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04719273, a Phase 2 study of Refractory Endometrial Carcinoma and Refractory Endometrial Endometrioid Adenocarcinoma, is active but no longer recruiting, sponsored by Thomas Jefferson University.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 14 participants
- Enrollment target
- 2
- Study locations
Study Summary
This phase II trial studies the effect of onapristone and anastrozole in treating patients with hormone receptor positive endometrial cancer that has not responded to previous treatment (refractory). Progesterone and estrogen are hormones that can cause the growth of endometrial cancer cells. Onapristone blocks the use of progesterone by the tumor cells. Anastrozole is a drug that blocks the production of estrogen in the body. Giving onapristone with anastrozole may work better than anastrozole alone in treating patients with hormone receptor positive endometrial cancer.
Primary Outcome
Defined by the percentage of patients with tumor response (complete response \[CR\] or partial response \[PR\]) as defined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Conditions Studied
Interventions
- OTHER Quality-of-Life Assessment
- OTHER Questionnaire Administration
- DRUG Anastrozole
- DRUG Extended-release Onapristone
- DIAGNOSTIC_TEST Estrogen Receptor Positive (Positive Estrogen Receptor; ESR Positive; ESR1 Positive; ER Positive; Estrogen Receptor Alpha Positive)
Study Locations (2)
Pennsylvania
- Jefferson Abington Hospital - Abington
- Thomas Jefferson University - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 14 participants |
| Start Date | 2021-01-28 |
| Est. Completion | 2025-12-31 |
| Phase | Phase 2 |
What the registry record for NCT04719273 still lists
NCT04719273 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 14 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (89% lower).
The record links to 7 conditions, with Refractory Endometrial Carcinoma appearing as the primary indexed condition, and to 5 interventions - of which Quality-of-Life Assessment is the first listed.
NCT04719273 reports a single indexed study location in Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT04719273 about?
NCT04719273 is a clinical study titled "Onapristone and Anastrozole for the Treatment of Refractory Hormone Receptor Positive Endometrial Cancer". This phase II trial studies the effect of onapristone and anastrozole in treating patients with hormone receptor positive endometrial cancer that has not responded to previous treatment (refractory). Progesterone and estrogen are hormones that can cause the growth of endometrial cancer cells. Onapri...
What is the current status of trial NCT04719273?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 14 participants. The study started on 2021-01-28. Estimated completion is 2025-12-31.
What conditions does trial NCT04719273 study?
This clinical trial studies the following conditions: Refractory Endometrial Carcinoma, Refractory Endometrial Endometrioid Adenocarcinoma, Refractory Endometrial Adenocarcinoma, Refractory Endometrial Clear Cell Adenocarcinoma, Refractory Endometrial Mixed Cell Adenocarcinoma.
What interventions are being tested in trial NCT04719273?
The interventions under investigation include: Quality-of-Life Assessment (OTHER), Questionnaire Administration (OTHER), Anastrozole (DRUG), Extended-release Onapristone (DRUG), Estrogen Receptor Positive (Positive Estrogen Receptor; ESR Positive; ESR1 Positive; ER Positive; Estrogen Receptor Alpha Positive) (DIAGNOSTIC_TEST).
Who is sponsoring clinical trial NCT04719273?
This trial is sponsored by Thomas Jefferson University, which has 292 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04719273 being conducted?
This trial has 2 study locations across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT04719273's enrollment target sits among peer trials
14 1941st of 2000 higher than 54 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
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