Trial · NCT03348631
Tazemetostat in Treating Patients With Recurrent Ovarian or Endometrial Cancer
NCT03348631, Phase 2, Active not recruiting, National Cancer Institute (NCI); results first posted 2025-03-06
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Tazemetostat in Treating Patients With Recurrent Ovarian or Endometrial Cancer. Trials, record NCT03348631. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03348631
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Tazemetostat in Treating Patients With Recurrent Ovarian or Endometrial Cancer
- NCT number
- NCT03348631
- Status
- Active not recruiting
- Phases
- Phase 2
- Enrollment
- 62 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
Recurrent Endometrial Endometrioid Adenocarcinoma, Recurrent Malignant Uterine Corpus Neoplasm, Recurrent Ovarian Carcinoma, Recurrent Ovarian Clear Cell Adenocarcinoma, Recurrent Ovarian Endometrioid Adenocarcinoma
- Interventions
- Computed Tomography, Magnetic Resonance Imaging, Tazemetostat
- First posted
- 2017-11-21
- Last updated
- 2026-10-26
- Results first posted
- 2025-03-06
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Tumor Response | Up to 6 months | Will be defined by Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1. The statistic reported is the response rate (i.e. (total responses / total at risk) \* 100). |
| Secondary | Tumor Response in Patients With ARID1A Mutations Using Tumor Response (Removed as of Version Date 20-OCT-2021) | Up to 6 months | Will be defined by RECIST v 1.1. |
| Secondary | 6-month Progression Free Survival (Clinical Benefit Rate) | Up to 6 months | Six-month progression free survival (clinical benefit rate). The clinical benefit rate is the total number (or percentage) of patients who had a complete response, or a partial response or who had stable disease for six months or more. |
| Secondary | Number of Patients With a Grade 3 (or Higher) Adverse Events | Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). | Will be assessed according to grade of toxicity by organ or organ system. This will be reported by group (Endometrial or Ovarian). This study reported adverse events by CTCAE v5.0. |
| Secondary | Progression-free Survival | Progression-free survival times were collected for a maximum of 30.0 months (interquartile range: 1.8 months, 5.5 months). | Will be characterized by quartiles and the median of the distribution with confidence intervals. Kaplan-Meier plots will show an estimate of the survival function for these populations. |
| Secondary | Overall Survival | Overall survival times were collected for a maximum of 51.6 months (interquartile range: 4.3 months, 19.0 months). | Will be characterized by quartiles and the median of the distribution with confidence intervals. Kaplan-Meier plots will show an estimate of the survival function for these populations. |
| Other | ARID1A Mutational Status | Up to 6 months | ARID1A mutational status was ealuated by MSK-IMPACT. |
| Other | BAF250a Expression | Up to 6 months | BAF250a expression was assessed by immunohistochemistry (IHC) as an indicator of ARID1A mutation status. |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Tumor Response | Up to 6 months | Eligible and Evaluable | Response/Patient (Percentage) | NUMBER |
| SECONDARY | Tumor Response in Patients With ARID1A Mutations Using Tumor Response (Removed as of Version Date 20-OCT-2021) | Up to 6 months | |||
| SECONDARY | 6-month Progression Free Survival (Clinical Benefit Rate) | Up to 6 months | Eligible and evaluable | Percentage with 6-month PFS | NUMBER |
| SECONDARY | Number of Patients With a Grade 3 (or Higher) Adverse Events | Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). | Eligible and Evaluable | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Progression-free Survival | Progression-free survival times were collected for a maximum of 30.0 months (interquartile range: 1.8 months, 5.5 months). | Eligible and Evaluable | months | MEDIAN |
| SECONDARY | Overall Survival | Overall survival times were collected for a maximum of 51.6 months (interquartile range: 4.3 months, 19.0 months). | Eligible and evaluable | months | MEDIAN |
| OTHER_PRE_SPECIFIED | ARID1A Mutational Status | Up to 6 months | |||
| OTHER_PRE_SPECIFIED | BAF250a Expression | Up to 6 months |
Source ClinicalTrials.gov
Results by group10
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Tumor Response | Arm I: Treatment (Tazemetostat) in Endometrial Cancer Patients | 0 | 95% Confidence Interval 0 to 15 | Response/Patient (Percentage) | |
| Tumor Response | Arm II: Treatment (Tazemetostat) Ovarian in Cancer Patients | 4.7 | 95% Confidence Interval 0.6 to 15.8 | Response/Patient (Percentage) | |
| 6-month Progression Free Survival (Clinical Benefit Rate) | Arm I: Treatment (Tazemetostat) in Endometrial Cancer Patients | 25 | 95% Confidence Interval 7.3 to 52.4 | Percentage with 6-month PFS | |
| 6-month Progression Free Survival (Clinical Benefit Rate) | Arm II: Treatment (Tazemetostat) Ovarian in Cancer Patients | 19 | 95% Confidence Interval 8.6 to 34.1 | Percentage with 6-month PFS | |
| Number of Patients With a Grade 3 (or Higher) Adverse Events | Arm I: Treatment (Tazemetostat) in Endometrial Cancer Patients | 6 | Participants | ||
| Number of Patients With a Grade 3 (or Higher) Adverse Events | Arm II: Treatment (Tazemetostat) Ovarian in Cancer Patients | 20 | Participants | ||
| Progression-free Survival | Arm I: Treatment (Tazemetostat) in Endometrial Cancer Patients | 2.05 | 95% Confidence Interval 1.84 to 5.49 | months | |
| Progression-free Survival | Arm II: Treatment (Tazemetostat) Ovarian in Cancer Patients | 3.04 | 95% Confidence Interval 2.04 to 4.37 | months | |
| Overall Survival | Arm I: Treatment (Tazemetostat) in Endometrial Cancer Patients | 25.3 | 95% Confidence Interval 3.8 to NA | months | |
| Overall Survival | Arm II: Treatment (Tazemetostat) Ovarian in Cancer Patients | 13.7 | 95% Confidence Interval 8.0 to 22.4 | months |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Arm I: Treatment (Tazemetostat) in Endometrial Cancer Patients | 19 | |
| Overall Study | STARTED | Arm II: Treatment (Tazemetostat) Ovarian in Cancer Patients | 43 | |
| Overall Study | COMPLETED | Arm I: Treatment (Tazemetostat) in Endometrial Cancer Patients | 16 | |
| Overall Study | COMPLETED | Arm II: Treatment (Tazemetostat) Ovarian in Cancer Patients | 42 | |
| Overall Study | NOT COMPLETED | Arm I: Treatment (Tazemetostat) in Endometrial Cancer Patients | 3 | |
| Overall Study | NOT COMPLETED | Arm II: Treatment (Tazemetostat) Ovarian in Cancer Patients | 1 |
Source ClinicalTrials.gov
Adverse events326
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: Treatment (Tazemetostat) in Endometrial Cancer Patients | 7 | 16 | |
| other | Anemia | Blood and lymphatic system disorders | Arm II: Treatment (Tazemetostat) Ovarian in Cancer Patients | 16 | 42 | |
| other | Eosinophilia | Blood and lymphatic system disorders | Arm I: Treatment (Tazemetostat) in Endometrial Cancer Patients | 1 | 16 | |
| other | Eosinophilia | Blood and lymphatic system disorders | Arm II: Treatment (Tazemetostat) Ovarian in Cancer Patients | 0 | 42 | |
| other | Lymph node pain | Blood and lymphatic system disorders | Arm I: Treatment (Tazemetostat) in Endometrial Cancer Patients | 0 | 16 | |
| other | Lymph node pain | Blood and lymphatic system disorders | Arm II: Treatment (Tazemetostat) Ovarian in Cancer Patients | 1 | 42 | |
| other | Cardiac arrest | Cardiac disorders | Arm I: Treatment (Tazemetostat) in Endometrial Cancer Patients | 0 | 16 | |
| other | Cardiac arrest | Cardiac disorders | Arm II: Treatment (Tazemetostat) Ovarian in Cancer Patients | 1 | 42 | |
| other | Cardiac disorders - Other, specify | Cardiac disorders | Arm I: Treatment (Tazemetostat) in Endometrial Cancer Patients | 1 | 16 | |
| other | Cardiac disorders - Other, specify | Cardiac disorders | Arm II: Treatment (Tazemetostat) Ovarian in Cancer Patients | 0 | 42 |
1 to 10 of 326Source ClinicalTrials.gov
See all 326 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Arm I: Treatment (Tazemetostat) in Endometrial Cancer Patients | 11 | 16 |
| Total, all-cause mortality | Arm II: Treatment (Tazemetostat) Ovarian in Cancer Patients | 28 | 42 |
| Total, other adverse events | Arm I: Treatment (Tazemetostat) in Endometrial Cancer Patients | 15 | 16 |
| Total, other adverse events | Arm II: Treatment (Tazemetostat) Ovarian in Cancer Patients | 40 | 42 |
| Total, serious adverse events | Arm I: Treatment (Tazemetostat) in Endometrial Cancer Patients | 3 | 16 |
| Total, serious adverse events | Arm II: Treatment (Tazemetostat) Ovarian in Cancer Patients | 12 | 42 |
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 comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Arm I: Treatment (Tazemetostat) in Endometrial Cancer Patients vs Arm II: Treatment (Tazemetostat) Ovarian in Cancer Patients: Number of Patients With a Grade 3 (or Higher) Adverse Events | Trial comparisons |
| Arm I: Treatment (Tazemetostat) in Endometrial Cancer Patients vs Arm II: Treatment (Tazemetostat) Ovarian in Cancer Patients: deaths from any cause | Trial comparisons |
| Arm I: Treatment (Tazemetostat) in Endometrial Cancer Patients vs Arm II: Treatment (Tazemetostat) Ovarian in Cancer Patients: 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/NCT03348631
GET https://conductscience.org/api/trials/v1/NCT03348631/events?page=2