TRIAL DETAIL

Sorafenib in Treating Patients With Malignant Gastrointestinal Stromal Tumor That Progressed During or After Previous Treatment With Imatinib Mesylate and Sunitinib Malate

Drug:
Trial Name:
Sorafenib in Treating Patients With Malignant Gastrointestinal Stromal Tumor That Progressed During or After Previous Treatment With Imatinib Mesylate and Sunitinib Malate
NCT#:
Conditions:
Gastrointestinal Stromal Tumor
Status:
Ongoing, but not recruiting
Phase:
2
Start Date 09/01/2005
Age of Trial (yrs) 18.6
Treatment Phase:
Gleevec-resistant
Drug Category:
KIT/PDGFRA inhibitor+ VEGF inhibitor (TKI) + RAF inhibitor
Strategy:
Block KIT + Block KIT Signal Path
Trial Type:
Specifically GIST and only GIST
Other Protocol IDs:
CDR000045354, UCCRC-13780A, NCI-7028
Sponsor:
University of Chicago, NCI
Patient Contact:
Clinical Trials Office - University of Chicago Cancer Research
Contact email:
Contact Phone:
773-834-7424
Randomized:
IV or Oral:
Oral
Trial Notes:
Note: University of Chicago maintains a central contact point for this trial.
Contact: University of Chicago Clinical Trials Office, 773-834-7424

Official Title: A Phase II Study of BAY 43-9006 for Imatinib- and Sunitinib-Resistant Malignant Gastrointestinal Stromal Tumor

Sorafenib (Nexavar / Bay 43-9006) is an oral tyrosine kinase inhibitor. It is FDA approved for kidney and liver cancer but not for GIST. This is phase II trial to see if sorafenib has activity in Gleevec and Sutent resistant GIST.
Sorafenib inhibits KIT, BRAF, mutant BRAF (including the V600E mutation), VEGFR 1,2,3, CRAF and PDGFRB. It is manufactured by Bayer and Onyx.

Further study details as provided by National Cancer Institute (NCI):
Primary Outcome Measures:
* Objective response rate (partial and complete response) [ Designated as safety issue: No ]

Secondary Outcome Measures:
* Overall survival [ Designated as safety issue: No ]
* Progression-free survival [ Designated as safety issue: No ]

Estimated Enrollment: 42
Study Start Date: September 2005
Estimated Primary Completion Date: July 2006 (Final data collection date for primary outcome measure)
Detailed Description:
OBJECTIVES:
Primary
* Determine the objective response rate (partial and complete response) in patients with imatinib mesylate- and sunitinib malate-resistant malignant gastrointestinal stromal tumor treated with sorafenib.
Secondary
* Determine the toxicity of this drug in these patients.
* Determine the progression-free survival and overall survival of patients treated with this drug.
OUTLINE: This is a multicenter study. Patients are stratified according to response to prior treatment with imatinib mesylate and sunitinib malate (imatinib mesylate- and sunitinib malate-responsive disease vs primary imatinib mesylate- and sunitinib malate-refractory disease).

Patients receive oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed periodically.
PROJECTED ACCRUAL: A total of 42 patients will be accrued for this study.

Trial Links

 
 

Trial Results

 
 
 
 
 
 
 
 
 
 
 

Drug Information

Nexavar.com
 
NexConnect patient support program
 
Nexavar REACH program for insurance coverage
 
Nexavar prescribing information (PDF)
 
What do I need to know about my Nexavar Therapy? (English) PDF Bayer Brochure
 
What do I need to know about my Nexavar Therapy? (Spanish) PDF
 
What do I need to know about my Nexavar Therapy? (Chinese) PDF
 
What do I need to know about my Nexavar Therapy? (Korean) PDF
 
Managing the side effects of sorafenib and sunitinib (PDF)
 
What do I need to know about my Nexavar Therapy? (Japanese) PDF
 
What do I need to know about my Nexavar Therapy? (Vietnamese) PDF
 
Sorafenib fourth-line treatment in imatinib, sunitinib and nilotinib resitant metastatic GIST: A retrospective analysis
 
Scientific Discussion - EMEA 2006 (PDF) - See PDF under the Assessment history tab.
 
NCI Cancer Bullentin-Trial Suggests New Treatment Option for Gastrointestinal Stromal Tumors
 
Association of Skeletal Muscle Wasting With Treatment With Sorafenib in Patients With Advanced Renal Cell Carcinoma: Results From a Placebo-Controlled Study
 
Abstract - Sorafenib induces growth suppression in mouse model of GIST
 
Hand-Foot Skin Reaction (HFSR) - Nexavar website
 
Suppression of the Nitric Oxide Pathway in Metastatic Renal Cell Carcinoma Patients Receiving VEGF inhibitors (PDF)
 
Skin tumors induced by sorafenib; Paradoxical RAS-RAF pathway activation and oncogenic mutations of HRAS, TP53 and TGFBR1
 
Bienvenido a Nexavar Latinoamérica
 
Patient Information - FDA approved patient labeling (PDF)
 
Evolving Strategies for the Management of Hand–Foot Skin Reaction Associated with the Multitargeted Kinase Inhibitors Sorafenib and Sunitinib (full text article/PDF)
 
A Phase II Trial of Intrapatient Dose-Escalated Sorafenib in Patients With Metastatic Renal Cell Carcinoma
 
BAY 43-9006 Exhibits Broad Spectrum Oral Antitumor Activity and Targets the RAF/MEK/ERK Pathway and Receptor Tyrosine Kinases Involved in Tumor Progression and Angiogenesis
 
Early Sorafenib-Induced Toxicity Is Associated with Drug Exposure and UGTIA9 Genetic Polymorphism in Patients with Solid Tumors: A Preliminary Study (full text article)
 
Pancreatic Atrophy — A New Late Toxic Effect of Sorafenib
 

Trial Sites

Name
Address
City
State
Zip
Country
5841 S. Maryland Ave
Chicago
IL
60637
USA
1275 York Ave
New York
NY
10065
USA
1500 E. Duarte Road
Duarte
CA
91010
USA
8940 N Wood Sage Rd
Peoria
IL
61615
USA
2880 N. Monroe
Decatur
IL
62526
USA
1441 Eastlake Avenue
Los Angeles
CA
90033
USA
4501 X St
Sacramento
CA
95817
USA
319 E. Madison St.
Springfield
IL
62701
USA
1500 East Medical Center Dr
Ann Arbor
MI
48109
USA
8701 Watertown Plank Rd.
Milwaukee
WI
53226
USA