TRIAL DETAIL

Study of Regorafenib as a 3rd-line or Greater Treatment for Gastrointestinal Stromal Tumors (GIST) (GRID)

Drug:
Trial Name:
Study of Regorafenib as a 3rd-line or Greater Treatment for Gastrointestinal Stromal Tumors (GIST) (GRID)
NCT#:
Conditions:
Gastrointestinal Stromal Tumor
Status:
Ongoing, but not recruiting
Phase:
3
Start Date 01/06/2011
Age of Trial (yrs) 11
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:
14874, EudraCT: 2009-017957-37
Sponsor:
Bayer
Patient Contact:
Bayer: clinical-trials-contact@bayerhealthcare.com Contact: For trial location information (Phone Menu Options '3' or '4'): +1 888 84 22937
Contact email:
Contact Phone:
Randomized:
Randomized
IV or Oral:
Oral
Trial Notes:
Note: Bayer issued a press release on April 3, 2012 stating that this trial had met its primary endpoint of a statistically significant progression-free survival (PFS). See links.

A randomized, double-blind, placebo-controlled phase III study of regorafenib plus best supportive care versus placebo plus best supportive care for subjects with metastatic and/or unresectable gastrointestinal stromal tumors (GIST) whose disease has progressed despite prior treatment with at least imatinib and sunitinib.

The study is composed of 3 periods: A Screening Period, a Treatment Period, and a Survival Follow up Period.

Subjects randomized to be treated with regorafenib will receive 160 mg po od for 3 weeks of every 4 week (28 day) cycle (ie, 3 weeks on/1 week off). In addition subjects will receive best supportive care which excludes any disease specific anti cancer therapy such as any kinase inhibitor, chemotherapy, radiation therapy, or surgery.

Tumor assessment will be every 4 weeks for the first 3 months, every 6 weeks for the next 3 months (through month 6), and every 8 weeks until the end of treatment, or more frequently if clinically indicated. Tumor assessments include 'CT or MRI and will be performed until tumor progression is seen in a central radiology review.

Subjects receiving placebo who experience disease progression may be offered active treatment.

Subjects who experience progression during regorafenib treatment may continue open label treatment.

All subjects will enter the Survival Follow-up Period upon discontinuation of randomized study treatment.

For a complete list of sites that include those that are not yet recruiting, see the NCT link above to view the complete trial listing in clinicaltrials.gov.

Treatment with prior VEGF inhibitors (except Sutent), such as Nexavar (sorafenib) or Votrient (pazopanib) will exclude patients from participating in this trial.

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
Innrain 52
Innsbruck
6020
Austria
Graz
Austria
Herestraat 49
Leuven
Belgium
Wilrijkstraat 10
Antwerp
Belgium
Helsinki
FIN-00029
Finland
Oulu
Finland
Singapore
Singapore
28 rue Laennec
Lyon
Rhone
69373
France
Lille
59020
France
Tuebingen
D-72076
Germany
Villejuif
Val de Narne
94805
France
Pieskower Straße 33
Bad Saarow
15526
Germany
Hufelandstr. 55
Essen
45122
Germany
Mannheim
68167
Germany
Hannover
30625
Germany
via Giacomo
Milan
20133
Italy
Chiba
277-8577
Japan
Niigata
951-8520
Japan
Osaka
Japan
Chuo-ku
Tokyo
104-0045
Japan
Hokkaido
Japan
Kumamoto
860-8556
Japan
450 Brookline Ave
Boston
MA
02215-5450
USA
Leiden
2333
Netherlands
600 University Ave.
Toronto
ON
M5G 1X5
Canada
229 Cours Argonne
Bordeaux
Gironde
33076
France
264 Rue Saint Pierre
Marseille
Bouches du Rhone
13386
France
viale orazio flacco,65
Bari
70124
Italy
Seoul
Songpa-gu
138-736
Republic of Korea
Busan
Republic of Korea
Goyang
410-768
Republic of Korea
Carrer de Sant Antoni Maria Clare, 167
Barcelona
08025
Spain
Leicester
UK
333 Cottman Ave
Philadelphia
PA
19111
USA
101 DAEHAK-RO
Seoul
110-774
Republic of Korea
Via del Vespro, 129
Palermo
90127
Italy
Beijing
100036
China
11560 University Avenue
Edmonton
AB
T6G 1Z2
Canada
London
ON
N6A 4L6
Canada
Nanjing
Jiangsu
210002
China
Besancon
Doubs
25030
France
2650 Ridge Avenue
Evanston
IL
60201
USA
Minneapolis
MN
55455
USA
Matsuyama
791-0280
Japan
1775 Dempster St.
Park Ridge
IL
60068
USA
3181 S.W. Sam Jackson Park Rd.
Portland
OR
97239
USA
550 Wilmslow Rd
Manchester
Lancashire
M20 4BX
UK
Surrey
sM2 5PT
UK
Warsaw
02-781
Poland
Beersheba
Israel
Cambridge
CB2 OQQ
UK
10460 N. 92nd St.
Scottsdale
AZ
85258
USA
Florence
Italy
1275 York Ave
New York
NY
10065
USA
1665 N. Ursula St.
Aurora
CO
80045
USA
1802 6th Ave. South
Birmingham
AL
35294
USA
La Jolla
CA
92093
USA
875 Blake Wilbur Drive
Palo Alto
CA
94304
USA