Daily Oral Regorafenib for Chemotherapy-Refractory, Metastatic and Locally Advanced Angiosarcoma
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|ClinicalTrials.gov Identifier: NCT02048722|
Recruitment Status : Active, not recruiting
First Posted : January 29, 2014
Last Update Posted : February 18, 2020
|Condition or disease||Intervention/treatment||Phase|
|Adult Angiosarcoma Recurrent Adult Soft Tissue Sarcoma Stage III Adult Soft Tissue Sarcoma Stage IV Adult Soft Tissue Sarcoma||Drug: regorafenib||Phase 2|
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
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.
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||31 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Multicenter, Open-Label Phase II Study of Daily Oral Regorafenib for Chemotherapy-Refractory, Metastatic and Locally Advanced Angiosarcoma|
|Study Start Date :||March 2014|
|Estimated Primary Completion Date :||November 2020|
|Estimated Study Completion Date :||February 2022|
Experimental: Treatment (regorafenib)
Patients receive regorafenib PO QD on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
- Progression-Free Survival (PFS) at 4 months [ Time Frame: At 4 months (of treatment) ]PFS will be evaluated at 4 months and will be defined as the absence of disease progression.
- Progression-Free Rate (PFR) at 3 and 6 months [ Time Frame: Assessed at 3 months and 6 months ]Patients will be evaluated at 3 and 6 months for the absence of disease progression, this data will be used to calculate the PFR.
- Progression-free survival (PFS) [ Time Frame: The duration of time from start of treatment until time of progression, up to 5 years ]PFS will be measured as the duration of time from the start of treatment until the time of disease progression, patients will be followed-up with for up to 5 years.
- Overall survival [ Time Frame: From start of treatment up to 5 years ]Once off-treatment, patients will be followed for overall survival for up to 5 years.
- Response rate (of tumor to treatment) [ Time Frame: At baseline and after every 2 cycles, up to 7 years ]Imaging (such as a CT scan) will be done at baseline (within 4 weeks before the first dose) then after every 2 cycles while on treatment for tumor response evaluation.
- Rate and duration of tumor control [ Time Frame: At baseline and after every 2 cycles, up to 7 years ]Imaging will be used at baseline then after every 2 cycles while on treatment to measure tumor size and response to treatment, the data collected from all patients on study will be used to calculate the rate and duration of tumor control.
- Number of Grade 1, 2, 3, 4, and 5 Adverse Events Observed During Study Treatment (Defined by CTCAE v 4.0) [ Time Frame: Measured at baseline & at each cycle, for up to 7 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02048722
|United States, California|
|Sarcoma Oncology Center|
|Santa Monica, California, United States, 90403|
|United States, Florida|
|Mayo Clinic in Florida|
|Jacksonville, Florida, United States, 32224-9980|
|United States, Illinois|
|Chicago, Illinois, United States, 60611|
|United States, Iowa|
|University of Iowa|
|Iowa City, Iowa, United States, 52246|
|United States, Minnesota|
|University of Minnesota Medical Center-Fairview|
|Minneapolis, Minnesota, United States, 55455|
|Rochester, Minnesota, United States, 55905|
|United States, Missouri|
|Washington University-St. Louis|
|Saint Louis, Missouri, United States, 63110|
|Principal Investigator:||Mark Agulnik, M.D.||Northwestern University|