Clinical Trial NU 13S02
- Multicenter, Open-Label Phase II Study of Daily Oral Regorafenib for Chemotherapy-Refractory, Metastatic and Locally Advanced Angiosarcoma
- Principal Investigator
- Mark Agulnik
- Status: Accepting New Patients
- Study Type: Therapeutic, Treatment
- Protocol No:.NU 13S02
- The purpose of this study is to see whether a drug called regorafenib might be effective in treating angiosarcoma.
- This study is for patients who have a type of cancer called angiosarcoma that has gotten worse after they received chemotherapy. Regorafenib is a type of drug called a kinase inhibitor. Kinases are proteins (large molecules made up of various amino acids) on cells that send important signals to the cell’s control center. Regorafenib interferes with how some of these kinase proteins work. Some of these kinases in cancer cells might normally help the cancer cells grow or form new blood vessels that could feed a growing tumor. By blocking these proteins, regorafenib may help stop the growth of certain cancers. Regorafenib is currently approved by the Food and Drug Administration (FDA) for the treatment of certain cancers including colorectal cancer and gastrointestinal stromal tumors. Regorafenib is not approved by the FDA to treat angiosarcomas; therefore, its use in this study is considered investigational.
Some of the eligibility criteria include:
- Participants must have angiosarcoma that may not be removed with surgery.
- Participants must have cancer that has gotten worse after prior chemotherapy.
- Participants may not have had sorafenib treatment in the past.
- Participants must be 18 or older.
- Description of Treatment
- Participants in this study will take the study drug, regorafenib, by mouth every day for 21 days straight, followed by a 7 day break during which the study drug will not be taken. This is called a treatment cycle and the duration of each cycle is 4 weeks. The study doctor will reassess the participant's cancer after every 2 cycles of treatment (approximately every 8 weeks). Participants will continue to receive study treatment until their cancer gets worse, they experience unacceptable side effects, or they and/or the doctor feel it is in their best interest to stop.
- Sara Duffey
Clinical Research and Education Specialist
Robert H. Lurie Comprehensive Cancer Center
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- A Randomized, Open-Label, Phase 2 Trial of CMB305 (Sequentially Administered LV305 and G305) and Atezolizumab in Patients with Locally Advanced, Relapsed, or Metastatic Sarcoma Expressing NY-ESO-1
- A Phase II Study of Pazopanib with Oral Topotecan in Patients with Metastatic and Non-resectable Soft Tissue and Bone Sarcomas
- Phase II Study Evaluating the Role of Pazopanib in Angiosarcoma (OER-SAR-043)
- A Blanket Protocol to Study Oral Regorafenib in Patients with Refractory Liposarcoma, Osteogenic Sarcoma, and Ewing/Ewing–Like Sarcomas
- A Phase II Study of Pazopanib as Front-Line Therapy in Patients with Non-Resectable or Metastatic Soft Tissue Sarcomas Who Are Not Candidates for Chemotherapy
last updated: 22-Oct-16 04:26 PM
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