Clinical Trial: MGCD516 in Advanced Liposarcoma and Other Soft Tissue Sarcomas

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: A Phase II Trial of MGCD516, a Multi-receptor Tyrosine Kinase Inhibitor, in Advanced Liposarcoma and Other Soft Tissue Sarcomas

Brief Summary:

Primary Objective:

  • To assess the efficacy of MGCD516 in patients with advanced liposarcoma by evaluating the progression free rate at 12 weeks as compared historical controls.

Secondary Objectives:

  • To further evaluate the safety profile of MGCD516 by assessing adverse event rates (according to National Cancer Institute CTCAE version 4.0 criteria) in patients treated with this agent.
  • To assess the efficacy of MGCD516 in patients with advanced liposarcoma by evaluating the overall response rate (according to RECIST 1.1 criteria), progression free survival and overall survival in patients treated with this agent.

Detailed Summary:

Sarcomas comprise a heterogeneous group of uncommon solid tumors of mesenchymal origin, of which more than 50 subtypes have been defined. In 2015, approximately 11,930 people will be diagnosed with sarcoma, and 4,870 will die of the malignancy.

The primary management for most localized sarcomas is surgical resection when feasible. Unfortunately, therapeutic options for patients with metastatic or unresectable disease remain limited. The various subtypes of sarcoma differ greatly in their clinical and molecular characteristics as well as response to traditional cytotoxic agents and radiotherapy. Outcomes are generally poor in advanced disease, with doxorubicin or the combination of gemcitabine and docetaxel eliciting objective responses in about 25% of patients, with median overall survival from the diagnosis of metastatic disease limited to 12 to 18 months. For the majority of patients with advanced sarcomas, outcomes remain disappointing, and new approaches are urgently needed.


Sponsor: Gary Schwartz

Current Primary Outcome: Progression free rate [ Time Frame: 12 weeks ]

To assess the efficacy of MGCD516 in patients with advanced liposarcoma by evaluating the progression free rate at 12 weeks as compared historical controls.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Adverse event rate [ Time Frame: 12 weeks ]
    To evaluate the safety profile of MGCD516.
  • Overall response rate [ Time Frame: Up to 33 months ]
    To assess the efficacy of MGCD516 in patients with advanced liposarcoma.
  • Progression free survival rate [ Time Frame: Up to 33 months ]
    To assess the efficacy of MGCD516 in patients with advanced liposarcoma.
  • Overall survival rate [ Time Frame: Up to 33 months ]
    To assess the efficacy of MGCD516 in patients with advanced liposarcoma.


Original Secondary Outcome: Same as current

Information By: Columbia University

Dates:
Date Received: November 29, 2016
Date Started: November 2016
Date Completion: January 2020
Last Updated: November 29, 2016
Last Verified: November 2016