Clinical Trial NU SARC14S01
- A Blanket Protocol to Study Oral Regorafenib in Patients with Refractory Liposarcoma, Osteogenic Sarcoma, and Ewing/Ewing–Like Sarcomas
- Principal Investigator
- Mark Agulnik
- Status: Accepting New Patients
- Study Type: Therapeutic, Treatment
- Protocol No:.NU SARC14S01
- The purpose of this study is to compare the safety (side effects) and effectiveness of giving participants the study drug regorafenib versus a placebo (sugar pill).
- Regorafenib is approved in the United States to treat colon cancer and one form of sarcoma (GI Stromal Tumor, or GIST). We do not know, however, if regorafenib is a useful treatment for people with other types of sarcoma. Thus, the drug regorafenib is considered “investigational” in this study. The term “investigational” means that the drug used in this study has not been approved by the Food and Drug Administration (FDA). A drug similar to the one being tested in this study, called pazopanib, is approved to treat some sarcomas, but is not approved to treat the type of sarcoma included this this study. Because it is unknown if any of these types of drugs will help people with liposarcoma, osteosarcoma, or Ewing/Ewing-like sarcoma, the goal of this study is to find out if the study drug regorafenib is an effective treatment for people with sarcoma.
Some of the eligibility criteria include:
- Participants must have either liposarcoma, osteosarcoma or Ewing/Ewing-like sarcoma.
- The participant's sarcoma must be refractory, meaning it has stopped responding to other treatment.
- Participants must be 18 or older.
- Description of Treatment
- Participants in this study will be assigned to one of three different groups (cohorts) based on the type of sarcoma they have. Participants who have liposarcoma will be in Cohort A. Those who have osteosarcoma will be in Cohort B. Those in Cohorts A and B will be randomly assigned to get regorafenib or placebo. The study drug and placebo are tablets taken every day. Participants may continue to take the regorafenib/placabo as long as they do not have serious side effects and as long as their sarcoma is not measurably worse. If the tumor does get worse, and the participant was taking the placebo, they will be able to switch to the regorafenib. Participants who have Ewing or Ewing-like sarcoma will be assigned to Cohort C. These participants will all get the study drug regorafenib. These participants will be able to continue on the study drug as long as they do not have serious side effects and as long as their sarcoma is not measurably worse.
- Sara Duffey
Clinical Research and Education Specialist
Robert H. Lurie Comprehensive Cancer Center
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- Carboplatin-Paclitaxel Induction chemotherapy and ABT-888 (Veliparib) – a Phase 1/Randomized Phase 2 Study in Patients with 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 Phase II, Multicenter Study of the EZH2 Inhibitor Tazemetostat in Adult Subjects with INI1-Negative Tumors or Relapsed/Refractory Synovial Sarcoma
- Multicenter, Open-Label Phase II Study of Daily Oral Regorafenib for Chemotherapy-Refractory, Metastatic and Locally Advanced Angiosarcoma
- A Phase II Study of Pazopanib with Oral Topotecan in Patients with Metastatic and Non-resectable Soft Tissue and Bone 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: 23-Apr-17 08:50 AM
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