Trials / Completed
CompletedNCT02048722
Daily Oral Regorafenib for Chemotherapy-Refractory, Metastatic and Locally Advanced Angiosarcoma
Multicenter, Open-Label Phase II Study of Daily Oral Regorafenib for Chemotherapy-Refractory, Metastatic and Locally Advanced Angiosarcoma
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 31 (actual)
- Sponsor
- Northwestern University · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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 angiosarcoma that has gotten worse after they received chemotherapy. Regorafenib is a type of drug called a kinase inhibitor. Regorafenib interferes with how some 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.
Detailed description
PRIMARY OBJECTIVES: I. To define the progression-free survival (PFS) at 4 months with daily oral regorafenib (160 mg) in previously treated locally advanced/metastatic angiosarcoma patients SECONDARY OBJECTIVES: I. Progression-free rate at 3 and 6 months. II. Progression-free survival. III. Overall survival (up to 5 years). IV. Response rate (by Response Evaluation Criteria in Solid Tumors \[RECIST\] version \[v\] 1.1). V. Rate and duration of tumor control (complete response \[CR\] + partial response \[PR\] + stable disease \[SD\]). VI. Safety/tolerability of regorafenib. OUTLINE: Patients receive regorafenib orally (PO) once daily (QD) on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 6 months for up to 5 years.
Conditions
- Adult Angiosarcoma
- Recurrent Adult Soft Tissue Sarcoma
- Stage III Adult Soft Tissue Sarcoma
- Stage IV Adult Soft Tissue Sarcoma
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | regorafenib | Given PO |
Timeline
- Start date
- 2014-06-13
- Primary completion
- 2019-10-14
- Completion
- 2021-10-12
- First posted
- 2014-01-29
- Last updated
- 2022-04-25
- Results posted
- 2020-07-29
Locations
7 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT02048722. Inclusion in this directory is not an endorsement.