Trial · NCT04204941
Registered outcomes19
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 19 of 19
Download this page as JSON| 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 |
| Secondary | Duration of treatment (DOR) | Through study completion, an average of two years | Defined as the time from first documented evidence of CR or PR to the time of first documented disease progression or death, whichever occurs first |
| Secondary | Change from baseline in European Organisation for Research and Treatment of Cancer (EORTC) Core Quality of Life Questionnaire (QLQC) (EORTC QLQC-30) | Through study completion, an average of two years | The EORTC QLQC-30 physical function, role function, and global health status domains will be assessed |
| Secondary | Progression-Free Survival on Next Line of Therapy (PFS2) | Through study completion, an average of two years | Defined as time from randomization to objective tumor progression on next-line treatment or death, whichever occurs first |
| Secondary | Time to first subsequent anti-cancer therapy ((TFST) | Through study completion, an average of two years | Defined as the time from randomization to the time to first subsequent therapy |
| Secondary | Population PK parameters of tazemetostat when administered in combination with doxorubicin: Oral clearance (CL/F) | Cycles 1, 2, 3, and 5 of the first continuous 21-day cycles of combination therapy | CL/F is defined as the apparent oral clearance following administration of tazemetostat when administered in combination with doxorubicin |
| Secondary | Population PK parameters of tazemetostat when administered in combination with doxorubicin: oral volume of distribution (Vss). | Cycles 1, 2, 3, and 5 of the first continuous 21-day cycles of combination therapy | |
| Secondary | Population PK parameters of tazemetostat when administered in combination with doxorubicin: Area Under the Curve at steady state (AUCss) | Cycles 1, 2, 3, and 5 of the first continuous 21-day cycles of combination therapy | |
| Secondary | Population PK parameters of tazemetostat when administered in combination with doxorubicin: trough concentration (Ctrough) | Cycles 1, 2, 3, and 5 of the first continuous 21-day cycles of combination therapy | |
| Secondary | Population PK parameters of tazemetostat when administered in combination with doxorubicin: Cmax | Cycles 1, 2, 3, and 5 of the first continuous 21-day cycles of combination therapy |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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.
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