TRIAL DETAIL

Safety And Effectiveness Of Daily Dosing With Sunitinib Or Imatinib In Patients With Gastrointestinal Stromal Tumors (Resistant at 400 mg Imatinib)

Drug:
Trial Name:
Safety And Effectiveness Of Daily Dosing With Sunitinib Or Imatinib In Patients With Gastrointestinal Stromal Tumors (Resistant at 400 mg Imatinib)
NCT#:
Conditions:
Gastrointestinal Stromal Tumor
Status:
Terminated
Phase:
3
Start Date 07/01/2007
Age of Trial (yrs) 14.4
Treatment Phase:
Gleevec-resistant
Drug Category:
KIT/PDGFRA inhibitor
Strategy:
Block KIT
Trial Type:
Specifically GIST and only GIST
Other Protocol IDs:
A6181112
Sponsor:
Pfizer
Patient Contact:
Pfizer Oncology Clinical Trial Information Service 1-877-369-9753 PfizerCancerTrials@emergingmed.com 1-800-718-1021
Contact email:
Contact Phone:
Randomized:
Randomized
IV or Oral:
Oral
Trial Notes:
Termination Reason:
The study prematurely discontinued on July 27, 2009 due to poor recruitment and operational futility as a result of changes in clinical practice. There were no safety or efficacy concerns regarding the study in the decision to terminate the trial.
A phase IIIb study of patients with gastrointestinal stromal tumors who have had progressive disease while on 400 mg imatinib. Patients were randomly assigned to either sunitinib 37.5 mg daily or imatinib 800 mg daily. This study was designed to find the benefits and potential side effects of taking sunitinib or imatinib for approximately one year.

Trial Links

 
 

Trial Results

 

Drug Information

All about Sutent (LRG website)
 
Sutent.com
 
Managing the side effects of sunitinib: a practical guide
 
The Molecular Basis of Class Side Effects Due to Treatment with Inhibitors of the VEGF/VEGFR Pathway
 
Evolving Strategies for the Management of Hand–Foot Skin Reaction Associated with the Multitargeted Kinase Inhibitors Sorafenib and Sunitinib (Full text available)
 
Drug interactions (LRG site)
 
Sutent prescribing information
 
Adverse effects information for Sutent
 
Gleevec/Sutent drug interactions - by Alessandro Pasina
 
Sutent given U.S. approval (LRG story)
 
Sutent + Avastin trial halted - reports of several cases of microangiopathic hemolytic anemia (MAHA).
 
Better monitoring for Sutent-related heart problems may be warranted
 
Cardiotoxicity associated with another smart cancer drug, sunitinib (heartwire article)
 
Stability of sunitinib in oral suspension
 
Managing the side effects of sorafenib and sunitinib (PDF)
 
Sutent Patient Assistance Program in China
 
Marginal increase of sunitinib exposure by grapefruit juice
 
A pediatric phase I trial and pharmacokinetic (PK) study of sunitinib: A Children’s Oncology Group Phase I Consortium study
 
Hypertension (HTN) as a potential biomarker of efficacy in patients (pts) with gastrointestinal stromal tumor (GIST) treated with sunitinib (SU)
 
Clinical evaluation of continuous daily dosing of sunitinib malate in patients with advanced gastrointestinal stromal tumour after imatinib failure
 
Phase I and Pharmacokinetic Study of Sunitinib in Pediatric Patients with Refractory Solid Tumors: A Children's Oncology Group Study
 
Sunitinib-induced cardiotoxicity is mediated by off-target inhibition of AMP-activated protein kinase (full-text article)
 
Suppression of the Nitric Oxide Pathway in Metastatic Renal Cell Carcinoma Patients Receiving VEGF inhibitors (PDF)
 
Tolerability and pharmacokinetic profile of a sunitinib powder formulation in pediatric patients with refractory solid tumors: a Children's Oncology Group study
 
Management of side effects associated with sunitinib therapy for patients with renal cell carcinoma (PDF)
 
Transient sunitinib resistance in GIST
 
Prospective Evaluation of Sunitinib-Induced Cardiotoxicity in Patients with Metastatic Renal Cell Carcinoma
 
Population Pharmacokinetics of Sunitinib and it's active Metabolite SU012662 in Pediatric Patients with GIST or Other Solid Tumors
 

Trial Sites

Name
Address
City
State
Zip
Country
2650 Ridge Avenue
Evanston
IL
60201
USA
2100 Pfingsten Rd
Glenview
IL
60026
USA
777 Park Avenue West
Highland Park
IL
60035
USA
4100 John R
Detroit
MI
48201
USA
10 Barnes West Drive
Creve Coeur
MO
63141
USA
660 S. Euclid Ave
St. Louis
MO
63110
USA
150 Entrance Way
St. Peters
MO
63376
USA
622 W 168th St
New York
NY
10032
USA
333 Cottman Ave
Philadelphia
PA
19111
USA
Hamburg
22767
Germany
Lai Chi Kok
Kowloon
0
Hong Kong SAR
Tuen Mun
New Territories
0
Hong Kong SAR
via Giacomo
Milan
20133
Italy
Bologna
40138
Italy
San Giovanni Rotondo
Foggia
71013
Italy
Seoul
135-710
Republic of Korea
Seoul
138-736
Republic of Korea
Barcelona
08036
Spain
Valencia
46009
Spain
550 Wilmslow Rd
Manchester
Lancashire
M20 4BX
UK
197 Fulham Rd.
London
SW3 6JJ
UK
Tuebingen
D-72076
Germany
Mannheim
68135
Germany
Goettingen
37075
Germany
Glasgow
G12 0YH
UK
London
NW1 2PG
UK
Farmington Hills
MI
48334
USA
Henderson
NV
89074
USA
Las Vegas
NV
89102
USA
Las Vegas
NV
89106
USA
Las Vegas
NV
89148
USA
Cleveland
OH
44195
USA
Seoul
110-744
Republic of Korea
London
W1
UK
Marseille
13385
France
Hong Kong
0
Hong Kong