Clinical Trial Detail

Clinical Trials

Clinical Trial Detail

A Phase II, Multicenter Study of the EZH2 Inhibitor Tazemetostat in Adult Subjects With INI1-Negative Tumors or Relapsed/Refractory Synovial Sarcoma

Complete title: SC-4008, EZH-202, A Phase II, Multicenter Study of the EZH2 Inhibitor Tazemetostat in Adult Subjects with INI1-Negative Tumors or Relapsed/Refractory Synovial Sarcoma

Research Study Number SC-4008
 
Principal Investigator Erin Pinto
 
Phase II

Research Study Description

This is a Phase II, multicenter, open-label, single arm, 2-stage study of tazemetostat 800 mg BID administered orally in continuous 28 day cycles. Screening of subjects to determine eligibility for the study will be performed within 21 days of the first planned dose of tazemetostat. Eligible subjects will be enrolled into one of three cohorts based on tumor type:

- Cohort 1: MRT, RTK, ATRT, or selected tumors with rhabdoid features

- Cohort 2: Relapsed or refractory synovial sarcoma with SS18-SSX rearrangement

- Cohort 3: Other INI1 negative tumors, including: Epithelioid malignant peripheral nerve sheath tumor (EMPNST), Extraskeletal myxoid chondrosarcoma (EMC), Myoepithelial carcinoma,Other INI1-negative malignant tumors with Sponsor approval (e.g., dedifferentiated chordoma)

- Cohort 4: Renal medullary carcinoma (RMC)

- Cohort 5: Epithelioid sarcoma (ES)

Treatment with tazemetostat will continue until disease progression, unacceptable toxicity or withdrawal of consent, or termination of the study. Response assessment will be evaluated after 8 weeks of treatment and then every 8 weeks thereafter while on study.

Eligibility Criteria (must meet the following to participate in this study)

** For Eligibility information, please click on the "Look up trial at NIH" link above. **

Other eligibility criteria may apply.

Research Study Number SC-4008
 
Contact Advanced Therapeutics Study Line
 
Telephone 206/987-2553
 
E-mail
 

Keywords: Kidney Cancer; Pediatric Cancers, Miscellaneous; Ovarian Cancer; Sarcoma; Solid Tumors; Teratomas; Neoplasms, Germ Cell and Embryonal; Neuroendocrine Tumor; Sarcoma, Synovial; Urogenital Neoplasms; Urologic Neoplasms; Neuroectodermal Tumors; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms, Ductal, Lobular, and Medullary; Adenocarcinoma; Genital Neoplasms, Female; Endocrine Gland Neoplasms; Adnexal Diseases; Rhabdoid Tumor; Neoplasms, Complex and Mixed; Carcinoma, Medullary

Disclaimer: We update this information regularly. However, what you read today may not be completely up to date.

Please remember:

  • Talk to your health care providers first before making decisions about your health care.
  • Whether you are eligible for a research study depends on many things. There are specific requirements to be in research studies. These requirements are different for each study.

Subscribe to an RSS feed of all trials