Trial · NCT04719273
Onapristone and Anastrozole for the Treatment of Refractory Hormone Receptor Positive Endometrial Cancer
NCT04719273, Phase 2, Completed, Thomas Jefferson University
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Onapristone and Anastrozole for the Treatment of Refractory Hormone Receptor Positive Endometrial Cancer. Trials, record NCT04719273. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04719273
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Onapristone and Anastrozole for the Treatment of Refractory Hormone Receptor Positive Endometrial Cancer
- NCT number
- NCT04719273
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 14 participants, actual
- Lead sponsor
- Thomas Jefferson University
- Conditions
Refractory Endometrial Adenocarcinoma, Refractory Endometrial Carcinoma, Refractory Endometrial Clear Cell Adenocarcinoma, Refractory Endometrial Endometrioid Adenocarcinoma, Refractory Endometrial Mixed Cell Adenocarcinoma, Refractory Endometrial Serous Adenocarcinoma, Refractory Endometrial Undifferentiated Carcinoma
- Interventions
Extended-release Onapristone, Anastrozole, Quality-of-Life Assessment, Questionnaire Administration, Estrogen Receptor Positive (Positive Estrogen Receptor; ESR Positive; ESR1 Positive; ER Positive; Estrogen Receptor Alpha Positive), Progesterone Receptor Positive ( PGR Positive; PR Positive)
- First posted
- 2021-01-22
- Last updated
- 2026-07-17
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Objective Response Rate (ORR) | Up to 1 year post-treatment, up to 36 months total | 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. |
| Primary | Progression-Free Survival (PFS) | From treatment until disease progression or death, up to 25 months | Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. 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. |
| Secondary | Disease Control Rate | Up to 1 year post-treatment | Defined as best overall response of CR, PR, or stable disease lasting for \>= 24 weeks, per RECIST 1.1. |
| Secondary | Time to Response | up to 1 yr post treatment | Time to Response defined as time from randomization to first documented response (CR or PR) in months. |
| Secondary | Duration of Response in Participants With Complete Response | From the first date of documented response to progression or death due to endometrial cancer, assessed up to 1 year post-treatment | Duration of Response (DOR) is the time from the first documented achievement of a Partial Response (PR) or Complete Response (CR) until the date of confirmed disease Progression (PD) or death due to endometrial cancer. |
| Secondary | Duration of Response in Participants With Partial Response | From the first date of documented response to progression or death due to endometrial cancer, assessed up to 1 year post-treatment | Duration of Response (DOR) is the time from the first documented achievement of a Partial Response (PR) or Complete Response (CR) until the date of confirmed disease Progression (PD) or death due to endometrial cancer. |
| Secondary | Quality of Life Assessed by the Edmonton Symptom Assessment System | Up to 25 months | Quality of life and pain scores are defined by the Edmonton Symptom Assessment System (ESAS) using nine subjective patient measures of well-being including pain, tiredness, nausea, depression, anxiety, drowsiness, appetite, well-being, shortness of breath. Numerical Rating Scale (NRS): Each symptom, including Pain and Well-being (which reflects Quality of Life), is rated on a 0 to 10 scale. Pain Score: 0 = No pain, 10 = Worst possible pain. Quality of Life / Well-being Score: 0 = Best possible feeling of well-being (i.e., best QoL), 10 = Worst possible feeling of well-being (i.e., worst QoL). ESAS scores were collected over the course of treatment and follow-up. Results represent the mean score for each symptom averaged across all available assessments for each participant. Higher scores reflect greater symptom severity. Scores are reported as means with standard deviations. |
| Other | Estrogen Receptor and Progesterone Receptor Expression | Up to 1 year post-treatment | Assessed by immunohistochemistry and represented as a percentage prior to trial initiation and at progression. For analysis, ER/PR expression values were summarized according to each participant's best overall tumor response category-Complete Response (CR), Partial Response (PR), Stable Disease (SD), or Progressive Disease (PD)-as defined by RECIST criteria. Higher receptor expression is generally associated with more favorable treatment response, whereas lower expression is associated with poorer outcomes. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| P30CA056036 | Translational Research in Cancer | CHAPMAN, ANDREW | THOMAS JEFFERSON UNIVERSITY | NATIONAL CANCER INSTITUTE | 1995 to 2025 |
Source NIH RePORTER
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04719273
GET https://conductscience.org/api/trials/v1/NCT04719273/registered