Sitravatinib 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 : March 11, 2019
|Condition or disease||Intervention/treatment||Phase|
|Liposarcoma Metastatic Liposarcoma||Drug: MGCD516||Phase 2|
Sarcomas are a group of cancers which arise from connective tissue and bone, of which more than 50 subtypes exist. Approximately 12,000 people are diagnosed with sarcoma annually in the United States.
Liposarcoma is one of the more common types of soft tissue sarcoma. The primary treatment for liposarcoma is surgery when possible. When liposarcoma is not amenable to surgery, various systemic treatments, including chemotherapy, are used. However, the effectiveness of existing treatments for liposarcoma is limited.
Sitravatinib is an oral, targeted drug which inhibits receptor tyrosine kinases. Receptor tyrosine kinases are proteins on the surface of the liposarcoma cell which play a role in cancer growth. In laboratory work, Sitravatinib effectively suppressed the growth of liposarcoma models. The purpose of this study is to evaluate the safety and efficacy of Sitravatinib in patients with liposarcoma which cannot be removed by surgery.
|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 Sitravatinib (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 2020|
|Estimated Study Completion Date :||January 2021|
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: Matthew Ingham, MD||212 305 firstname.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, Missouri|
|Saint Louis, Missouri, United States, 63130|
|Contact: Brian Van Tine, MD|
|United States, New York|
|Columbia University Irving Medical Center||Recruiting|
|New York, New York, United States, 10032|
|Contact: Matthew Ingham, MD 212-305-7115 firstname.lastname@example.org|
|Principal Investigator: Matthew Ingham, MD|
|Principal Investigator:||Matthew Ingham, MD||Columbia University|