SARC024: A Blanket Protocol to Study Oral Regorafenib in Patients With Selected Sarcoma Subtypes
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
Summary
- Conditions
- Ewing/Ewing-like Sarcoma
- Liposarcoma
- Mesenchymal Chondrosarcoma
- Osteogenic Sarcoma
- Rhabdomyosarcoma
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: RandomizedIntervention Model: Crossover AssignmentMasking: Triple (Participant, Care Provider, Investigator)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 5 years and 125 years
- Gender
- Both males and females
Description
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 pazop...
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
Tracking Information
- NCT #
- NCT02048371
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Robert Maki, MD, PhD University of Pennsylvania