Regorafenib in Patients With Metastatic and/or Unresectable Gastrointestinal Stromal Tumor
|ClinicalTrials.gov Identifier: NCT01068769|
Recruitment Status : Active, not recruiting
First Posted : February 15, 2010
Results First Posted : February 24, 2014
Last Update Posted : March 1, 2018
|Condition or disease||Intervention/treatment||Phase|
|Gastrointestinal Stromal Tumor||Drug: regorafenib||Phase 2|
- In this research study, each planned "cycle" of the study lasts 4 weeks. In the first cycle, participants will come to the clinic on Days 1, 15 and 16. For cycles 2 through 4, they will come to the clinic on Days 1 and 15 of each cycle. For cycle 5 and beyond, they will come to the clinic on Day 1 of each cycle. Repeat tumor imaging will be performed at the end of every 2 cycles during study drug administration (e.g. end of cycles 2, 4, 6, etc.)
- During each cycle, participants will take regorafenib by mouth, once a day in the morning, for 3 weeks followed by one week during which you do not take regorafenib (the "rest period").
- FDG-PET/CT (Positron Emission Tomography) scans are required as part of this study to monitor effects of the study drug on the participant's GIST. The first scan will take place before the first dose of study drug. If the first scan shows that the "tracer sugar" collection is increased in the participant's GIST, they will have up to 5 additional scans performed at different time points throughout their participation in this research study.
- Participants may continue to participate in this research study for as long as they do not have serious side effects or their disease does not get worse.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||34 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Multi-center Phase II Study Evaluating the Efficacy and Safety of Regorafenib in Patients With Metastatic and/or Unresectable Gastrointestinal Stromal Tumor (GIST), Resistent or Intolerant to at Least Imatinib and Sunitinib|
|Study Start Date :||February 2010|
|Primary Completion Date :||June 2012|
|Estimated Study Completion Date :||December 2018|
Regorafenib adminstered orally, 160 mg per day on days 1 through 21 of a 28 day cycle
Taken orally, once a day in the morning for 3 weeks followed by a one week rest period
Other Name: Stivarga
- Clinical Benefit as Defined by the Composite of Complete Response, Partial Response and Stable Disease Lasting 16 Weeks or More Per RECIST 1.1 as a Measure of Disease Control [ Time Frame: 2 years ]The composite of complete response, partial response, and stable disease lasting 16 weeks or more per RECIST 1.1 as a measure of disease control. This is for target lesions. Complete response is disappearance of all target lesions and partial response is >+30% decrease in the sum of the longest diameter of target lesions. Stable disease is neither shrinkage by greater than or equal to 30% of the sum of the longest diameter of target lesions or the increase of lesions by greater than or equal to 20% of the sum of the longest diameter of target lesions. Progressive disease is considered an increase of the sum of the longest diameter of target lesions by greater than or equal to 20%.
- Progression-free Survival (PFS) [ Time Frame: From date of enrollment until date of first documented progression or date of death from any cause, whichever came first ]Progression-free survival is defined as the duration of time from start of study drug administration to time of objective disease progression or death due to any cause, whichever comes first. Progression is evaluated every 8 weeks using Response Criteria for Solid Tumors (RECIST) 1.1. Objective disease progression is defined as a 20% increase in the sum of the longest diameter of target lesion(s).
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01068769
|United States, Massachusetts|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02114|
|Dana-Farber Cancer Institute|
|Boston, Massachusetts, United States, 02115|
|United States, Oregon|
|Oregon Health Sciences University|
|Portland, Oregon, United States, 97239|
|United States, Pennsylvania|
|Fox Chase Cancer Center|
|Philadelphia, Pennsylvania, United States, 19111|
|Principal Investigator:||Suzanne George, MD||Dana-Farber Cancer Institute|