SARC024; A Blanket Protocol to Study Oral Regorafenib in Patients With Refractory Liposarcoma Osteogenic Sarcoma and Ewing/Ewing-like Sarcomas
Investigating Regorafenib for Sarcoma Treatment
Brief description of study.
The purpose of this study is to examine regorafenib in a systematic fashion in patients with other forms of sarcoma.
Detailed description of study
Although regorafenib was approved for use in patients who had progressive GIST despite imatinib and/or sunitinib on the basis of phase II and phase III data, it has not been examined in a systematic fashion in patients with other forms of sarcoma. Given the activity of sorafenib, sunitinib and pazopanib in soft tissue sarcomas, and evidence of activity of sorafenib in osteogenic sarcoma and possibly Ewing/Ewing-like sarcoma, there is precedent to examine SMOKIs (small molecule oral kinase inhibitors) such as regorafenib in sarcomas other than GIST. It is also recognized that SMOKIs (small molecule oral kinase inhibitors)such as regorafenib, sorafenib, pazopanib, and sunitinib have overlapping panels of kinases that are inhibited simultaneously. While not equivalent, most of these SMOKIs (small molecule oral kinase inhibitors) block vascular endothelial growth factor and platelet derived growth factors receptors (VEGFRs and PDGFRs), speaking to a common mechanism of action of several of these agents.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Liposarcoma
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Age: 18 years - 100 years
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Gender: All
Inclusion Criteria
Patients must have histologically or cytologically confirmed advanced/metastatic liposarcoma, osteogenic sarcoma, or Ewing/Ewing-like sarcoma of soft tissue or bone
At least one prior line of systemic therapy for the sarcoma diagnosis (neoadjuvant, adjuvant or metastatic disease)
Must be able to swallow and retain oral medication
Adequate organ function within 14 days of registration INR (International Normalized Ratio)
Exclusion Criteria
Prior systemic therapy with a small molecule oral kinase inhibitor
Previous assignment to treatment during this study
Concurrent, clinically significant, active malignancies within 12 months of study enrollment
Severe and/or uncontrolled concurrent medical disease that in the opinion of the investigator could cause unacceptable safety risks or compromise compliance with the protocol
Major surgery within 28 days prior to study registration or those patients who have not recovered adequately from prior surgery
Women who are pregnant or breast-feeding
The purpose of this study is to examine regorafenib in patients with different types of sarcoma, a kind of cancer that affects the body's connective tissues. This study investigates how regorafenib, which is part of a group of drugs called small molecule oral kinase inhibitors (SMOKIs), works in sarcomas other than gastrointestinal stromal tumors (GIST). These inhibitors block certain proteins that help cancer cells grow, and this study aims to understand their effects on sarcomas.
Participants in this study will take regorafenib orally. Regorafenib works by inhibiting certain proteins that are involved in cancer cell growth. This study will look at its impact on sarcoma tumors, including liposarcoma, osteogenic sarcoma, and Ewing/Ewing-like sarcoma. Participants will not receive any payment for their involvement in the study.
- Who can participate: Adults with advanced or metastatic liposarcoma, osteogenic sarcoma, or Ewing/Ewing-like sarcoma are eligible. Participants must have had at least one prior systemic therapy and be able to swallow oral medication. Adequate organ function is required. Exclusion criteria include no prior SMOKI treatment and no recent major surgery.
- Study details: Participants will take regorafenib, an investigational medication that blocks certain proteins in cancer cells. The study involves taking this medication orally to assess its effects on sarcoma tumors.
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