Sarcoma Oncology Research Center | Santa Monica, CA
Status and phase
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About
The participants of this study will have advanced epithelioid sarcoma. Sarcoma is a cancer of the connective tissues, such as nerves, muscles and bones. Epithelioid sarcoma is an ultra-rare sarcoma of the soft-tissue.
Part 1 of this trial will evaluate the safety and the level of the study drug that the study drug combinations can be tolerated (known as tolerability). It is also designed to establish a recommended study drug dosage for the next part of the study.
Part 2 will evaluate and compare for each of the study drug combinations how long participants live without their disease getting worse.
The study drug is called tazemetostat. The study will test tazemetostat in combination with doxorubicin compared to placebo (dummy treatment) in combination with doxorubicin. Doxorubicin is a current front line treatment for epithelioid sarcoma
Full description
The open-label phase 1b portion is designed to evaluate the safety of the combination of tazemetostat + doxorubicin, as well as to establish the maximum tolerated dose (MTD) and the RP3D. The phase 3 portion of the clinical trial aims to compare tazemetostat + doxorubicin to the current front-line standard treatment, single-agent doxorubicin + placebo, when used as first-line treatment in locally advanced unresectable or metastatic ES.
Enrollment
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Inclusion and exclusion criteria
Inclusion Criteria
Participants must meet ALL the following inclusion criteria to be eligible to enroll in this study:
Exclusion Criteria
Participants meeting ANY of the following exclusion criteria are NOT eligible to enroll in this study:
Primary purpose
Allocation
Interventional model
Masking
164 participants in 2 patient groups, including a placebo group
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Central trial contact
Ipsen Recruitment Enquiries
Data sourced from clinicaltrials.gov
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