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

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: A Phase II Study of Mocetinostat Administered With Gemcitabine for Patients With Metastatic Leiomyosarcoma With Progression or Relapse Following Prior Treatment With Gemci

Brief Summary: The purpose of this study is to assess the response rate (per RECIST 1.1) in participants who receive mocetinostat and gemcitabine after documented progression of leiomyosarcoma on a gemcitabine containing regimen.

Detailed Summary:
Sponsor: Sarcoma Alliance for Research through Collaboration

Current Primary Outcome: Response rate (per RECIST 1.1) in participants who receive mocetinostat and gemcitabine [ Time Frame: 27 months ]

Response rate (CR or PR) will be calculated by the number of patients achieving a response divided by the number of patients having been evaluated for response.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Duration of response in participants who receive mocetinostat and gemcitabine [ Time Frame: 27 months ]
    The duration of objective response will be measured from the time measurement criteria are first met until disease progression is objectively documented.
  • Progression free survival (PFS) in participants who receive mocetinostat and gemcitabine [ Time Frame: 27 months ]
    Progression free survival is defined as the time from treatment initiation to the earlier date of assessment of objective progression or death by any cause in the absence of progression.
  • Number and type of Adverse Events related to oral mocetinostat when given in combination with infusional gemcitabine at a rate of 10 mg/m2/min. [ Time Frame: 27 months ]


Original Secondary Outcome: Same as current

Information By: Sarcoma Alliance for Research through Collaboration

Dates:
Date Received: November 21, 2014
Date Started: September 2015
Date Completion: January 2018
Last Updated: August 23, 2016
Last Verified: August 2016