Trial · NCT04204941
Tazemetostat in Combination With Doxorubicin as Frontline Therapy for Advanced Epithelioid Sarcoma
NCT04204941, Phase 1, Terminated, Epizyme, Inc.
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Tazemetostat in Combination With Doxorubicin as Frontline Therapy for Advanced Epithelioid Sarcoma. Trials, record NCT04204941. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04204941
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Tazemetostat in Combination With Doxorubicin as Frontline Therapy for Advanced Epithelioid Sarcoma
- NCT number
- NCT04204941
- Status
- Terminated
- Phases
- Phase 1
- Enrollment
- 25 participants, actual
- Lead sponsor
- Epizyme, Inc.
- Conditions
- Advanced Soft-tissue Sarcoma, Advanced Epithelioid Sarcoma
- Interventions
- Tazemetostat, Doxorubicin HCl
- First posted
- 2019-12-19
- Last updated
- 2026-01-07
- Other registries' IDs
- eudract:2019-003648-55
Source ClinicalTrials.gov
Registered outcomes19
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Dose Limiting Toxicities (DLTs) | 1 Cycle/21 days | Determined by Adverse Events (AEs) and clinical laboratory tests. |
| Primary | Progression free survival (PFS) | Through study completion, an average of two years. | Phase 3: Assessed by Independent Review Committee. Phase 3 was planned but never initiated; therefore, no data were collected for these endpoints |
| Secondary | Phase 1b: Pharmacokinetics (PK) of tazemetostat when administered in combination with doxorubicin in participants with soft tissue sarcoma (STS): Area under the Plasma Concentration Time Curve from time 0 to 24 hours (AUC0-24) | Cycles 1, 2, 3, and 5 of the first continuous 21-day cycles of combination therapy | |
| Secondary | Phase 1b: PK of tazemetostat when administered in combination with doxorubicin in participants with STS: Area under the Plasma Concentration Time Curve From time 0 to the last observable concentration (AUC0- last) | Cycles 1, 2, 3, and 5 of the first continuous 21-day cycles of combination therapy | |
| Secondary | Phase 1b: PK of tazemetostat when administered in combination with doxorubicin in Participants with STS: The maximum observed concentration (Cmax). | Cycles 1, 2, 3, and 5 of the first continuous 21-day cycles of combination therapy | |
| Secondary | Phase 3: Overall Survival (OS) | Through study completion, an average of two years. | Phase 3 was planned but never initiated; therefore, no data were collected for these endpoints |
| Secondary | Phase 3: Incidence of Adverse Events (AEs) | Through study completion, an average of two years. | All AEs, including clinically significant laboratory parameters will be graded by the investigator according to the Common Terminology Criteria for Adverse Events (CTCAE). Phase 3 was planned but never initiated; therefore, no data were collected for these endpoints |
| Secondary | Phase 3: PFS | Through study completion, an average of two years. | Assessed by the investigator. Phase 3 was planned but never initiated; therefore, no data were collected for these endpoints |
| Secondary | Disease control rate (DCR) | Through study completion, an average of two years | Defined as the number of participants who achieve response complete response (CR) + partial response (PR) or who have stable disease (SD). Phase 3 was planned but never initiated; therefore, no data were collected for these endpoints. |
| Secondary | Objective response rate (ORR) | Through study completion, an average of two years | ORR is defined as the proportion of participants achieving complete or partial response. Determined based on the Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 |
1 to 10 of 19Source ClinicalTrials.gov
See all 19 registered outcomesOutcomes0
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.
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 33035459 | DERIVED |
Source PubMed
Grants0
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.
None in this release.
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/NCT04204941
GET https://conductscience.org/api/trials/v1/NCT04204941/registered