Ignite Creation Date:
2024-05-06 @ 7:48 AM
Last Modification Date:
2024-10-26 @ 11:52 AM
Study NCT ID:
NCT02601937
Status:
COMPLETED
Last Update Posted:
2021-12-27
First Post:
2015-10-21
Brief Title:
EZH2 Inhibitor Tazemetostat in Pediatric Subjects With Relapsed or Refractory INI1-Negative Tumors or Synovial Sarcoma
Sponsor:
Epizyme Inc
Organization:
Epizyme Inc
Study Overview
Official Title:
A Phase 1 Study of the EZH2 Inhibitor Tazemetostat in Pediatric Subjects With Relapsed or Refractory INI1-Negative Tumors or 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 is a Phase I open-label dose escalation and dose expansion study with BID suspension and TID tablet oral dose of the enhancer of zeste homolog-2 EZH2 inhibitor tazemetostat Subjects will be screened for eligibility within 14 days of the planned first dose of tazemetostat A treatment cycle will be 28 days Response assessment will be evaluated after 8 weeks of treatment and subsequently every 8 weeks while on study
Detailed Description:
The study has two parts Dose Escalation and Dose Expansion
Dose escalation for subjects with the following relapsedrefractory malignancies
Rhabdoid tumors
Atypical teratoid rhabdoid tumor ATRT
Malignant rhabdoid tumor MRT
Rhabdoid tumor of kidney RTK
Selected tumors with rhabdoid features
Integrase interactor 1 INI1-negative tumors
Epithelioid sarcoma
Epithelioid malignant peripheral nerve sheath tumor
Extraskeletal myxoid chondrosarcoma
Myoepithelial carcinoma
Renal medullary carcinoma
Other INI1-negative malignant tumors eg dedifferentiated chordoma
Synovial Sarcoma with a SS18-SSX rearrangement Dose Escalation cohorts are closed to enrollment
Dose Expansion at the maximum tolerated dose MTD or the recommended phase 2 dose RP2D
Cohort 1 - ATRT
Cohort 2 - MRTRTKselected tumors with rhabdoid features
Cohort 3 - INI-negative tumors
Epithelioid sarcoma
Epithelioid malignant peripheral nerve sheath tumor
Extraskeletal myxoid chondrosarcoma
Myoepithelial carcinoma
Renal medullary carcinoma
Chordoma poorly differentiated or de-differentiated
Other INI1-negative malignant tumors eg dedifferentiated chordoma
Cohort 4 - Tumor types eligible for Cohorts 1 through 3 or synovial sarcoma with SS18-SSX rearrangement
Dose escalation for subjects with the following relapsedrefractory malignancies
Rhabdoid tumors
Atypical teratoid rhabdoid tumor ATRT
Malignant rhabdoid tumor MRT
Rhabdoid tumor of kidney RTK
Selected tumors with rhabdoid features
Integrase interactor 1 INI1-negative tumors
Epithelioid sarcoma
Epithelioid malignant peripheral nerve sheath tumor
Extraskeletal myxoid chondrosarcoma
Myoepithelial carcinoma
Renal medullary carcinoma
Other INI1-negative malignant tumors eg dedifferentiated chordoma
Synovial Sarcoma with a SS18-SSX rearrangement Dose Escalation cohorts are closed to enrollment
Dose Expansion at the maximum tolerated dose MTD or the recommended phase 2 dose RP2D
Cohort 1 - ATRT
Cohort 2 - MRTRTKselected tumors with rhabdoid features
Cohort 3 - INI-negative tumors
Epithelioid sarcoma
Epithelioid malignant peripheral nerve sheath tumor
Extraskeletal myxoid chondrosarcoma
Myoepithelial carcinoma
Renal medullary carcinoma
Chordoma poorly differentiated or de-differentiated
Other INI1-negative malignant tumors eg dedifferentiated chordoma
Cohort 4 - Tumor types eligible for Cohorts 1 through 3 or synovial sarcoma with SS18-SSX rearrangement
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None