Ignite Creation Date:
2024-05-06 @ 7:50 AM
Last Modification Date:
2024-10-26 @ 11:52 AM
Study NCT ID:
NCT02601950
Status:
COMPLETED
Last Update Posted:
2024-07-01
First Post:
2015-10-21
Brief Title:
A Study of Tazemetostat in Adult Participants With Soft Tissue Sarcoma
Sponsor:
Epizyme Inc
Organization:
Ipsen
Study Overview
Official Title:
A Phase II Multicenter Study of the EZH2 Inhibitor Tazemetostat in Adult Subjects With INI1-Negative Tumors or RelapsedRefractory Synovial Sarcoma
Status:
COMPLETED
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will include participants with various types of cancer known as soft-tissue sarcomas
Tissues that can be affected by soft tissue sarcomas include fat muscle blood vessels deep skin tissues tendons and ligaments
Soft tissue cancers are rare and can occur almost anywhere in the body
Part 1 of this trial will study the safety and the level that adverse effects of the study drug tazemetostat in combination with doxorubicin current front line treatment 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 how long participants live without their disease getting worse when receiving the study drug plus doxorubicin versus doxorubicin plus placebo dummy treatment
Tissues that can be affected by soft tissue sarcomas include fat muscle blood vessels deep skin tissues tendons and ligaments
Soft tissue cancers are rare and can occur almost anywhere in the body
Part 1 of this trial will study the safety and the level that adverse effects of the study drug tazemetostat in combination with doxorubicin current front line treatment 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 how long participants live without their disease getting worse when receiving the study drug plus doxorubicin versus doxorubicin plus placebo dummy treatment
Detailed Description:
This is a Phase II multicenter open-label single arm 2-stage study of tazemetostat 800 mg BID twice daily and 1600 mg QD once daily Subjects will be screened for eligibility within 21 days of the planned date of the first dose of tazemetostat and enrolled into one of 8 cohorts
Cohort using tazemetostat 800 mg BID
Cohort 1 Closed for enrollment malignant rhabdoid tumor MRT rhabdoid tumor of the kidney RTK atypical teratoid rhabdoid tumor ATRT and selected tumors with rhabdoid features including small cell carcinoma of the ovary hypercalcemic type SCCOHT also known as malignant rhaboid tumor of the ovary MRTO
Cohort 2 Closed for enrollment Relapsed or refractory synovial sarcoma with SS18-SSX rearrangement
Cohort 3 Closed for enrollment Other integrase interactor 1 INI1 negative tumors or any solid tumor with an enhancer of zeste homologue-2 EZH2 gain of function GOF mutation including epithelioid malignant peripheral nerve sheath tumor EMPNST extraskeletal myxoid chondrosarcoma EMC myoepithelial carcinoma other INI1-negative malignant tumors with Sponsor approval eg dedifferentiated chordoma any solid tumor with an EZH2 GOF mutation including but not limited to Ewings sarcoma and melanoma
Cohort 4 Closed for enrollment Renal medullary carcinoma RMC
Cohort 5 Closed for enrollment Epithelioid sarcoma ES
Cohort 6 Closed for enrollment Epithelioid sarcoma ES undergoing mandatory tumor biopsy
Cohort 7 Closed for enrollment Poorly differentiated chordoma or other chordoma with Sponsor approval
Cohort using tazemetostat 1600 mg QD
Cohort 8 Closed for enrollment Epitheliod sarcoma
Participants will be dosed in continuous 28-day cycles Note if treatment with study drug is discontinued prior to completing 2 years subjects will be followed for a maximum duration of 2 years from start of study drug dosing Response assessment will be performed every 8 weeks while on study
Treatment with tazemetostat will continue until disease progression unacceptable toxicity or withdrawal of consent or termination of the study
Cohort using tazemetostat 800 mg BID
Cohort 1 Closed for enrollment malignant rhabdoid tumor MRT rhabdoid tumor of the kidney RTK atypical teratoid rhabdoid tumor ATRT and selected tumors with rhabdoid features including small cell carcinoma of the ovary hypercalcemic type SCCOHT also known as malignant rhaboid tumor of the ovary MRTO
Cohort 2 Closed for enrollment Relapsed or refractory synovial sarcoma with SS18-SSX rearrangement
Cohort 3 Closed for enrollment Other integrase interactor 1 INI1 negative tumors or any solid tumor with an enhancer of zeste homologue-2 EZH2 gain of function GOF mutation including epithelioid malignant peripheral nerve sheath tumor EMPNST extraskeletal myxoid chondrosarcoma EMC myoepithelial carcinoma other INI1-negative malignant tumors with Sponsor approval eg dedifferentiated chordoma any solid tumor with an EZH2 GOF mutation including but not limited to Ewings sarcoma and melanoma
Cohort 4 Closed for enrollment Renal medullary carcinoma RMC
Cohort 5 Closed for enrollment Epithelioid sarcoma ES
Cohort 6 Closed for enrollment Epithelioid sarcoma ES undergoing mandatory tumor biopsy
Cohort 7 Closed for enrollment Poorly differentiated chordoma or other chordoma with Sponsor approval
Cohort using tazemetostat 1600 mg QD
Cohort 8 Closed for enrollment Epitheliod sarcoma
Participants will be dosed in continuous 28-day cycles Note if treatment with study drug is discontinued prior to completing 2 years subjects will be followed for a maximum duration of 2 years from start of study drug dosing Response assessment will be performed every 8 weeks while on study
Treatment with tazemetostat will continue until disease progression unacceptable toxicity or withdrawal of consent or termination of the study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2015-002469-41 | EUDRACT_NUMBER | None | None |