TRIAL DETAIL

Regorafenib in Subjects With Gastrointestinal Stromal Tumors (GIST) Who Have Progressed After Standard Therapy

Drug:
Trial Name:
Regorafenib in Subjects With Gastrointestinal Stromal Tumors (GIST) Who Have Progressed After Standard Therapy
NCT#:
Conditions:
Gastrointestinal Stromal Tumor
Status:
No longer avalable
Phase:
3
Start Date 07/01/2012
Age of Trial (yrs) 12.4
Treatment Phase:
Gleevec-resistant
Drug Category:
KIT/PDGFRA inhibitor
Strategy:
Block KIT + Block blood vessel growth
Trial Type:
Specifically GIST and only GIST
Other Protocol IDs:
16339
Sponsor:
Bayer
Patient Contact:
Bayer Clinical Trials Contact clinical-trials contact@bayerhealthcare.com For trial location information (Phone Menu Options '3' or '4' (+)1-888-842-2937
Contact email:
Contact Phone:
Randomized:
IV or Oral:
Oral
Trial Notes:
This is a treatment use trial, designed to allow expanded access to regorafenib during the time between completion of the randomized phase III trial and possible drug approval.
160 mg regorafenib, 3 weeks on drug, 1 week off.
Note: In clinicaltrials.gov this trial is listed as "Available".
Use the contact information supplied for more information about clinical trial sites that are available.

Trial Links

Trial Results

Drug Information
Phase III Trial of Investigational Compound Regorafenib (BAY 73-4506) in Metastatic Gastrointestinal Stromal Tumors (GIST) Meets Primary Endpoint of Improving Progression-Free Survival
 
Regorafenib Effective for Gastrointestinal Stromal Tumor When Other Treatments Stop Working
 
IJC Dec. 2010: REGORAFENIB (BAY 73-4506): A NEW ORAL MULTIKINASE INHIBITOR OF ANGIOGENIC, STROMAL, AND ONCOGENIC RECEPTOR TYROSINE KINASES WITH POTENT PRECLINICAL ANTITUMOR ACTIVITY
 
Prous Drug Data Report 2009, 31(7): REGORAFENIB*Rec INN 395674
 
2012 GI ASCO - Colorectal cancer results from randomized phase III trial (CORRECT)
 
JCO Vol 25, No 18S (June 20 Supplement), 2007 Abs: 3593 Phase I study of BAY 73–4506, Hedblom, S.
 
InSciences 22 September 2009, 03:17 Bayer’s Novel Anti-Cancer Compound Regorafenib (BAY 73-4506) Showed Stabilization or Regression in 81 Percent of Kidney Cancer Patients
 
Regorafenib Induces Rapid and Reversible Changes in Plasma Nitric Oxide and Endothelin-1
 
Regorafenib (BAY 73-4506): A new oral multikinase inhibitor of angiogenic, stromal and oncogenic receptor tyrosine kinases with potent preclinical antitumor activity
 
OncLive - Short Video - Dr. George Demetri explains the side effects of regorafenib
 
OncoLIve - Short Video - Dr. George Demetri discusses regorafenib for GIST
 
OncoLive - Regorafenib extends survival in colorectal cancer, delays disease progression in GIST
 
August 30, 2012 - Press Release - Bayer Submits New Drug Application for Regorafenib for the Treatment of Gastrointestinal Stromal Tumors
 
Expanded access trial opens to provide Regorafenib in Subjects With Gastrointestinal Stromal Tumors (GIST) Who Have Progressed After Standard Therapy
 
Stivarga prescribing information
 
Press release - Bayer’s Stivarga® (regorafenib) Tablets Approved by U.S. FDA for Treatment of Metastatic Colorectal Cancer (PDF)
 
Stivarga.com - Bayer page about Stivarga (regorafenib)
 
Stivarga - Access and Assistance program
 
OncLive - Peter Reichardt, MD, PhD perspective - In refractory GIST, regorafenib delays disease progression across all subgroups
 
October 29th, 2012 - Bayer's Stivarga (regorafenib) tablets new drug application granted priority review by U.S. FDA for the treatment of patients with Gastrointestinal Stromal Tumors
 
November 27th, 2012 - Publication of two pivotal Phase III studies of regorafenib: Positive Phase III Data on Bayer’s Regorafenib in Metastatic Colorectal Cancer (mCRC) and Gastrointestinal Stromal Tumor (GIST) Published in The Lancet
 
Standard versus personalized schedule of regorafenib in metastatic gastrointestinal stromal tumors: a retrospective, multicenter, real-world study
 

Trial Sites

Name
Address
City
State
Zip
Country
450 Brookline Ave
Boston
MA
02215-5450
USA
2000 Circle of Hope
Salt Lake City
UT
84103
USA