Clinical Trial: Daily Oral Regorafenib for Chemotherapy-Refractory, Metastatic and Locally Advanced Angiosarcoma

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Multicenter, Open-Label Phase II Study of Daily Oral Regorafenib for Chemotherapy-Refractory, Metastatic and Locally Advanced Angiosarcoma

Brief 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 Summary:

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.


Sponsor: Northwestern University

Current Primary Outcome: 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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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 ]


Original Secondary Outcome: Same as current

Information By: Northwestern University

Dates:
Date Received: January 22, 2014
Date Started: March 2014
Date Completion:
Last Updated: November 23, 2016
Last Verified: November 2016