Trial · NCT03018249
Medroxyprogesterone Acetate With or Without Entinostat Before Surgery in Treating Patients With Endometrioid Endometrial Cancer
NCT03018249, Early phase 1, Completed, National Cancer Institute (NCI); results first posted 2021-06-02
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Medroxyprogesterone Acetate With or Without Entinostat Before Surgery in Treating Patients With Endometrioid Endometrial Cancer. Trials, record NCT03018249. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03018249
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Medroxyprogesterone Acetate With or Without Entinostat Before Surgery in Treating Patients With Endometrioid Endometrial Cancer
- NCT number
- NCT03018249
- Status
- Completed
- Phases
- Early phase 1
- Enrollment
- 50 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
- FIGO Grade 1 Endometrial Endometrioid Adenocarcinoma, FIGO Grade 2 Endometrial Endometrioid Adenocarcinoma, FIGO Grade 3 Endometrial Endometrioid Adenocarcinoma
- Interventions
- Entinostat, Hysterectomy, Laboratory Biomarker Analysis, Medroxyprogesterone Acetate
- First posted
- 2017-01-12
- Last updated
- 2021-11-16
- Results first posted
- 2021-06-02
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Mean Post-treatment Tumor Progesterone Receptor H-score (Histology Score) | Specimens were collected at hysterectomy on day 21-24 and analyzed in batch. | The H-score is defined as the percent cells staining positive (0-100) multiplied by the staining intensity (0, 1, 2 or 3) measured in the tumor by immunohistochemistry and averaged over 3 reviewers. This score can range from 0 to 300. In general, PRs are expected to decrease in response to medroxyprogesterone acetate. It was hypothesized that entinostat would mitigate the decrease in PR relative to the medroxyprogesterone acetate only arm post treatment. Higher PR H-scores post treatment in the arm with entinostat relative to the medroxyprogesterone alone arm would be consistent with this hypothesis. Arm II was thought to result in higher scores which was expected to have a more favorable outcome when treated with MPA therapy. |
| Secondary | Percentage of Participants With a Histologic Response | Specimens were collected at initial diagnostic biopsy and at hysterectomy on day 21-24 and analyzed in batch. | Pre- and post-treatment slides for each patient were evaluated in pairs for complete or partial histologic response by one reviewer. Pre- and post-treatment slides for each patient were evaluated in pairs for complete or partial histologic response by one reviewer. A histologic response was defined as either the absence of identifiable adenocarcinoma in the hysterectomy specimen section (complete) or, subjectively, as the presence of a complex proliferation of glands that retain the architectural characteristics of adenocarcinoma, but with features of secretion, decreased nuclear stratification, or the presence of eosinophilic, squamous or mucinous metaplasia, when this was absent in the initial sample (partial). |
| Secondary | Percent of Participants With a Ki67 Response | Specimens were collected at initial diagnostic biopsy and at hysterectomy on day 21-24 and analyzed in batch. | A response was defined as a decrease in Ki-67 protein expression in tumor from pre- to post-treatment. |
| Secondary | The Frequency and Severity of CTCAE Version 4.0 Graded Adverse Events (AE) | Up to 45 days after surgery | Maximum grade of physician assessed adverse events reported during treatment and up to 45 days after surgery. Grades start with 1 which is considered mild through grade 5 which is death. Participants on this study had adverse event grades up to grade 3 which is considered moderately severe. |
| Other | Mean Post-treatment Tumor Estrogen Receptor Score | Up to 3 years | |
| Other | Co-expression of PR, Ki67, and p21 | Up to 3 years | Will be compared between the arms. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Mean Post-treatment Tumor Progesterone Receptor H-score (Histology Score) | Specimens were collected at hysterectomy on day 21-24 and analyzed in batch. | Randomized, treated, evaluable specimen. There were 2 participants in each reporting group who withdrew consent prior to treatment; no specimens were submitted for these patients. There were two additional patients with insufficient tumor post-treatment and no slides were submitted; one in each reporting group. There was one additional patient with no specimens submitted in reporting group 2. | units on a scale | MEAN |
| SECONDARY | Percentage of Participants With a Histologic Response | Specimens were collected at initial diagnostic biopsy and at hysterectomy on day 21-24 and analyzed in batch. | Randomized, treated, evaluable pre and post treatment specimen available. There were 2 participants in each reporting group who withdrew consent prior to treatment; no specimens were submitted for these patients. There was one participant with an inevaluable pre-treatment slide. There were two additional patients with insufficient tumor post-treatment and no slides were submitted; one in each reporting group. There was one additional patient with no specimens submitted in reporting group 2. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Percent of Participants With a Ki67 Response | Specimens were collected at initial diagnostic biopsy and at hysterectomy on day 21-24 and analyzed in batch. | Randomized, treated, evaluable pre and post treatment specimens available. There were 2 participants in each reporting group who withdrew consent prior to treatment; no specimens were submitted for these patients. There was one participant with an inevaluable pre-treatment slide. There were two additional patients with insufficient tumor post-treatment and no slides were submitted; one in each reporting group. There was one additional patient with no specimens submitted in reporting group | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | The Frequency and Severity of CTCAE Version 4.0 Graded Adverse Events (AE) | Up to 45 days after surgery | Eligible and Treated Patients | participants | NUMBER |
| OTHER_PRE_SPECIFIED | Mean Post-treatment Tumor Estrogen Receptor Score | Up to 3 years | |||
| OTHER_PRE_SPECIFIED | Co-expression of PR, Ki67, and p21 | Up to 3 years |
Source ClinicalTrials.gov
Results by group16
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Mean Post-treatment Tumor Progesterone Receptor H-score (Histology Score) | Arm I (Medroxyprogesterone Acetate, Hysterectomy) MPA | 53.6 | Standard Deviation 64.8 | units on a scale | |
| Mean Post-treatment Tumor Progesterone Receptor H-score (Histology Score) | Arm II (Medroxyprogesterone Acetate, Entinostat, Hysterectomy) MPA and Entinostat | 42.7 | Standard Deviation 49.0 | units on a scale | |
| Percentage of Participants With a Histologic Response | Arm I (Medroxyprogesterone Acetate, Hysterectomy) MPA | 16 | Participants | ||
| Percentage of Participants With a Histologic Response | Arm II (Medroxyprogesterone Acetate, Entinostat, Hysterectomy) MPA and Entinostat | 14 | Participants | ||
| Percent of Participants With a Ki67 Response | Arm I (Medroxyprogesterone Acetate, Hysterectomy) MPA | 15 | Participants | ||
| Percent of Participants With a Ki67 Response | Arm II (Medroxyprogesterone Acetate, Entinostat, Hysterectomy) MPA and Entinostat | 18 | Participants | ||
| The Frequency and Severity of CTCAE Version 4.0 Graded Adverse Events (AE) | Arm I (Medroxyprogesterone Acetate, Hysterectomy) MPA | Grade 1 AE | 11 | participants | |
| The Frequency and Severity of CTCAE Version 4.0 Graded Adverse Events (AE) | Arm II (Medroxyprogesterone Acetate, Entinostat, Hysterectomy) MPA and Entinostat | Grade 1 AE | 9 | participants | |
| The Frequency and Severity of CTCAE Version 4.0 Graded Adverse Events (AE) | Arm I (Medroxyprogesterone Acetate, Hysterectomy) MPA | Grade 2 AE | 4 | participants | |
| The Frequency and Severity of CTCAE Version 4.0 Graded Adverse Events (AE) | Arm II (Medroxyprogesterone Acetate, Entinostat, Hysterectomy) MPA and Entinostat | Grade 2 AE | 6 | participants |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Arm I (Medroxyprogesterone Acetate, Hysterectomy) MPA | 25 | |
| Overall Study | STARTED | Arm II (Medroxyprogesterone Acetate, Entinostat, Hysterectomy) MPA and Entinostat | 25 | |
| Overall Study | COMPLETED | Arm I (Medroxyprogesterone Acetate, Hysterectomy) MPA | 23 | |
| Overall Study | COMPLETED | Arm II (Medroxyprogesterone Acetate, Entinostat, Hysterectomy) MPA and Entinostat | 23 | |
| Overall Study | NOT COMPLETED | Arm I (Medroxyprogesterone Acetate, Hysterectomy) MPA | 2 | |
| Overall Study | NOT COMPLETED | Arm II (Medroxyprogesterone Acetate, Entinostat, Hysterectomy) MPA and Entinostat | 2 |
Source ClinicalTrials.gov
Adverse events58
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anemia | Blood and lymphatic system disorders | Arm I (Medroxyprogesterone Acetate, Hysterectomy) MPA | 3 | 23 | |
| other | Anemia | Blood and lymphatic system disorders | Arm II (Medroxyprogesterone Acetate, Entinostat, Hysterectomy) MPA and Entinostat | 3 | 23 | |
| other | Abdominal Pain | Gastrointestinal disorders | Arm I (Medroxyprogesterone Acetate, Hysterectomy) MPA | 4 | 23 | |
| other | Abdominal Pain | Gastrointestinal disorders | Arm II (Medroxyprogesterone Acetate, Entinostat, Hysterectomy) MPA and Entinostat | 8 | 23 | |
| other | Constipation | Gastrointestinal disorders | Arm I (Medroxyprogesterone Acetate, Hysterectomy) MPA | 5 | 23 | |
| other | Constipation | Gastrointestinal disorders | Arm II (Medroxyprogesterone Acetate, Entinostat, Hysterectomy) MPA and Entinostat | 4 | 23 | |
| other | Diarrhea | Gastrointestinal disorders | Arm I (Medroxyprogesterone Acetate, Hysterectomy) MPA | 2 | 23 | |
| other | Diarrhea | Gastrointestinal disorders | Arm II (Medroxyprogesterone Acetate, Entinostat, Hysterectomy) MPA and Entinostat | 4 | 23 | |
| other | Dry Mouth | Gastrointestinal disorders | Arm I (Medroxyprogesterone Acetate, Hysterectomy) MPA | 1 | 23 | |
| other | Dry Mouth | Gastrointestinal disorders | Arm II (Medroxyprogesterone Acetate, Entinostat, Hysterectomy) MPA and Entinostat | 2 | 23 |
1 to 10 of 58Source ClinicalTrials.gov
See all 58 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Arm I (Medroxyprogesterone Acetate, Hysterectomy) MPA | 0 | 23 |
| Total, all-cause mortality | Arm II (Medroxyprogesterone Acetate, Entinostat, Hysterectomy) MPA and Entinostat | 0 | 23 |
| Total, other adverse events | Arm I (Medroxyprogesterone Acetate, Hysterectomy) MPA | 14 | 23 |
| Total, other adverse events | Arm II (Medroxyprogesterone Acetate, Entinostat, Hysterectomy) MPA and Entinostat | 16 | 23 |
| Total, serious adverse events | Arm I (Medroxyprogesterone Acetate, Hysterectomy) MPA | 1 | 23 |
| Total, serious adverse events | Arm II (Medroxyprogesterone Acetate, Entinostat, Hysterectomy) MPA and Entinostat | 1 | 23 |
Source ClinicalTrials.gov
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 |
|---|---|---|---|---|---|
| U10CA180868 | NRG Oncology Network Group Operations Center | WOLMARK, NORMAN; Le, Quynh-Thu Xuan; MANNEL, ROBERT S. | NRG ONCOLOGY FOUNDATION, INC. | NATIONAL CANCER INSTITUTE | 2014 to 2026 |
Source NIH RePORTER
Trial comparisons4
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Arm I (Medroxyprogesterone Acetate, Hysterectomy) MPA vs Arm II (Medroxyprogesterone Acetate, Entinostat, Hysterectomy) MPA and Entinostat: Percent of Participants With a Ki67 Response | Trial comparisons |
| Arm I (Medroxyprogesterone Acetate, Hysterectomy) MPA vs Arm II (Medroxyprogesterone Acetate, Entinostat, Hysterectomy) MPA and Entinostat: deaths from any cause | Trial comparisons |
| Arm I (Medroxyprogesterone Acetate, Hysterectomy) MPA vs Arm II (Medroxyprogesterone Acetate, Entinostat, Hysterectomy) MPA and Entinostat: Percentage of Participants With a Histologic Response | Trial comparisons |
| Arm I (Medroxyprogesterone Acetate, Hysterectomy) MPA vs Arm II (Medroxyprogesterone Acetate, Entinostat, Hysterectomy) MPA and Entinostat: serious adverse events | Trial comparisons |
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/NCT03018249
GET https://conductscience.org/api/trials/v1/NCT03018249/events?page=2