MGCD516 in Advanced Liposarcoma and Other Soft Tissue Sarcomas
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|ClinicalTrials.gov Identifier: NCT02978859|
Recruitment Status : Recruiting
First Posted : December 1, 2016
Last Update Posted : January 10, 2018
- To assess the efficacy of MGCD516 in patients with advanced liposarcoma by evaluating the progression free rate at 12 weeks as compared historical controls.
- 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.
|Condition or disease||Intervention/treatment||Phase|
|Liposarcoma Metastatic Liposarcoma||Drug: MGCD516||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||29 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Trial of MGCD516, a Multi-receptor Tyrosine Kinase Inhibitor, in Advanced Liposarcoma and Other Soft Tissue Sarcomas|
|Actual Study Start Date :||November 2016|
|Estimated Primary Completion Date :||January 2019|
|Estimated Study Completion Date :||January 2020|
Patients with locally advanced and unresectable or metastatic sarcoma will receive MGCD516 at the discretion of the principal investigator until disease progression, unacceptable toxicity or adverse event(s) or withdrawal of consent.
Administered at 150 mg orally, daily, in continuous 21 day cycles. An orally available, potent small molecular inhibitor of several related receptor tyrosine kinases.
Other Name: Sitravatinib
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02978859
|Contact: Gary K Schwartz, MDfirstname.lastname@example.org|
|United States, Massachusetts|
|Massachussetts General Hospital||Recruiting|
|Boston, Massachusetts, United States, 02114-2696|
|Contact: Edwin Choy, MD, PhD 617-724-4000 email@example.com|
|Principal Investigator: Edwin Choy, MD, PhD|
|United States, New York|
|Columbia University Medical Center||Recruiting|
|New York, New York, United States, 10032|
|Contact: Gary K Schwartz, MD 212-305-2055 firstname.lastname@example.org|
|Principal Investigator: Gary K Schwartz, MD|
|Principal Investigator:||Gary K Schwartz, MD||Clyde '56 and Helen Wu Professor of Oncology (in Medicine), Dept of Med Hematology & Onc|