Regorafenib in Patients With Metastatic and/or Unresectable Gastrointestinal Stromal Tumor

This study is ongoing, but not recruiting participants.

Sponsor:

Collaborators:

Brigham and Women's Hospital

Massachusetts General Hospital

Fox Chase Cancer Center

Oregon Health and Science University

Bayer

Information provided by (Responsible Party):

Suzanne George, MD, Dana-Farber/Brigham and Women's Cancer Center

ClinicalTrials.gov Identifier:

NCT01068769

First received: February 12, 2010

Last updated: November 23, 2015

Last verified: November 2015

History of Changes

Results First Received: January 9, 2014

Study Type:	Interventional
Study Design:	Endpoint Classification: Safety/Efficacy Study; Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Gastrointestinal Stromal Tumor
Intervention:	Drug: regorafenib

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants were enrolled at three sites between February and December, 2010.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
Regorafenib	Regorafenib adminstered orally, 160 mg per day on days 1 through 21 of a 28 day cycle

Participant Flow: Overall Study

	Regorafenib
STARTED	34
COMPLETED	33
NOT COMPLETED	1
Ineligible	1

Baseline Characteristics

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Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Eligible patients were included in the baseline analysis population

Reporting Groups

	Description
Regorafenib	Regorafenib adminstered orally, 160 mg per day on days 1 through 21 of a 28 day cycle

Baseline Measures

	Regorafenib
Number of Participants [units: participants]	33
Age [units: years] Median (Full Range)	56 (25 to 76)
Gender [units: participants]
Female	14
Male	19
Region of Enrollment [units: participants]
United States	33

Outcome Measures

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1. Primary:

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 ]

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2. Secondary:

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 ]

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Measure Type	Secondary
Measure Title	Progression-free Survival (PFS)
Measure Description	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).
Time Frame	From date of enrollment until date of first documented progression or date of death from any cause, whichever came first
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups

	Description
Regorafenib	Regorafenib adminstered orally, 160 mg per day on days 1 through 21 of a 28 day cycle

Measured Values

	Regorafenib
Number of Participants Analyzed [units: participants]	33
Progression-free Survival (PFS) [units: months] Median (95% Confidence Interval)	10.0 (8.3 to 14.9)

No statistical analysis provided for Progression-free Survival (PFS)

Serious Adverse Events

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Other Adverse Events

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Limitations and Caveats

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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact:

Name/Title: Dr. Suzanne George
Organization: Dana-Farber Cancer Institute
phone: 617-632-5204
e-mail: sgeorge2@partners.org

Responsible Party:	Suzanne George, MD, Dana-Farber/Brigham and Women's Cancer Center
ClinicalTrials.gov Identifier:	NCT01068769 History of Changes
Other Study ID Numbers:	09-400
Study First Received:	February 12, 2010
Results First Received:	January 9, 2014
Last Updated:	November 23, 2015
Health Authority:	United States: Food and Drug Administration

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