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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- TPF Induction chemotherapy and ABT-888 (Veliparib) – a Phase 1/Randomized Phase 2 Study in Patients w/ Locoregionally Advanced Squamous Cell Carcinoma of the Head and Neck
- A Phase III Randomized Trial of Adding Vincristine-topotecan-cyclophosphamide to Standard Chemotherapy in Initial Treatment of Non-metastatic Ewing Sarcoma
- Pazopanib Neoadjuvant Trial In Non-Rhabdomyosarcoma Soft Tissue Sarcomas (PAZNTIS): A Phase II/III Randomized Trial of Preoperative Chemoradiation or Preoperative Radiation Plus or Minus Pazopanib (NSC# 737754, IND# 118613)
- A Randomized, Double-Blind, Placebo-Controlled Study of Chemotherapy Plus Cetuximab in Combination with VTX-2337 in Patients with Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck
- A Phase III Randomized Trial of Chemotherapy With or Without Bevacizumab in Patients with Recurrent or Metastatic Head and Neck Cancer
- Phase I/II trial of Cediranib alone or Cediranib and Lenalidomide in iodine 131-refractory differentiated thyroid cancer
- A Phase II Study of Tivozanib in Patients with Metastatic and Non-resectable Soft Tissue Sarcomas
- Phase II Study Evaluating the Role of Pazopanib in Angiosarcoma (OER-SAR-043)
- A Phase Ib/II Study of Gemcitabine and Docetaxel in Combination with Pazopanib (Gem/Doce/Pzb) for the Neoadjuvant Treatment of Soft Tissue Sarcoma (STS)
- A Blanket Protocol to Study Oral Regorafenib in Patients with Refractory Liposarcoma, Osteogenic Sarcoma, and Ewing/Ewing–Like Sarcomas
- Randomized Phase II Trial of Everolimus Versus Placebo as Adjuvant Therapy in Patients with Locally Advanced Squamous Cell Cancer of the Head and Neck (SCCHN)
last updated: 28-Jan-15 08:12 AM
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