SARC018-SPORE01

SARC018: A Study of Mocetinostat and Gemcitabine in Patients With Metastatic Leiomyosarcoma

TYPE OF SARCOMA: Metastatic Leiomyosarcoma
DRUG: Mocetinostat & Gemcitabine

ACCRUAL STATUS: Completed

OVERALL STUDY PRINCIPAL INVESTIGATORS:
Shreyas Patel, MD
Co-Principal Investigator
MD Anderson Cancer Center

Edwin Choy, MD, PhD
Co-Principal Investigator
MGH, Dana Farber/Harvard Cancer Center
Division of Hematology Oncology

CLINICALTRIALS.GOV IDENTIFIER: NCT02303262

FOR STUDY DETAILS AND ELIGIBILITY CRITERIA: CLINICALTRIALS.GOV

IMPACT STATEMENT:
Based on laboratory evidence that HDAC inhibition can help overcome chemoresistance, enhance chemotherapy induced cytotoxicity and decrease tumor cell proliferation, this clinical trial was designed as part of the SARC SPORE project 2. Mocetinostat was given along with Gemcitabine in patients with metastatic LMS who had documented progression after prior exposure to Gemcitabine. We showed feasibility, proof of principle activity, and safety for this combination.  However, the trial was terminated after completion of the first stage due to limited response rate observed at interim analysis.

PUBLICATIONS:
Choy E, Ballman K, Chen J, Dickson MA, Chugh R, George S, Okuno S, Pollock R, Patel RM, Hoering A, Patel S. SARC018_SPORE02: Phase II Study of Mocetinostat Administered with Gemcitabine for Patients with Metastatic Leiomyosarcoma with Progression or Relapse following Prior Treatment with Gemcitabine-Containing Therapy. Sarcoma. 2018 Oct 24;2018:2068517. doi: 10.1155/2018/2068517. Erratum in: Sarcoma. 2019 Aug 27;2019:7608743. PMID: 30473623; PMCID: PMC6220374.

Choy E, Ballman K, Chen J, Dickson MA, Chugh R, George S, Okuno S, Pollock R, Patel RM, Hoering A, Patel S. SARC018_SPORE02: Phase II Study of Mocetinostat Administered with Gemcitabine for Patients with Metastatic Leiomyosarcoma with Progression or Relapse following Prior Treatment with Gemcitabine-Containing Therapy. Sarcoma. 2018 Oct 24;2018:2068517. doi: 10.1155/2018/2068517. Erratum in: Sarcoma. 2019 Aug 27;2019:7608743. PMID: 30473623; PMCID: PMC6220374.

To learn more about this study or to contact the study research staff: