TRIAL DETAIL

Efficacy of Pazopanib in Gastrointestinal Stromal Tumors (GIST) (PAZOGIST)

Drug:
Trial Name:
Efficacy of Pazopanib in Gastrointestinal Stromal Tumors (GIST) (PAZOGIST)
NCT#:
Conditions:
Gastrointestinal Stromal Tumor
Status:
Completed
Phase:
2
Start Date 03/01/2011
Age of Trial (yrs) 10.8
Treatment Phase:
Gleevec-resistant
Drug Category:
KIT/PDGFRA inhibitor+ VEGF inhibitor (TKI)
Strategy:
Block KIT + Block blood vessel growth
Trial Type:
Specifically GIST and only GIST
Other Protocol IDs:
PAZOGIST
Sponsor:
Centre Leon Berard
Patient Contact:
Anne LEFRANC +33 478 78 59 46 lefranc@lyon.fnclcc.fr
Contact email:
Contact Phone:
Randomized:
Randomized
IV or Oral:
Oral
Trial Notes:
The purpose of this study is to evaluate the antitumor activity of pazopanib in patients with metastatic and/or locally advanced unresectable Gastrointestinal Stromal Tumors (GIST) resistant to imatinib and sunitinib. This is a phase II, randomized, multicentre study.

Patients must have progressed or have been intolerant (Grade 3) on both imatinib and sunitinib. Patients must also have an affiliation with an insurance company.

Patients will be randomly assigned to one of two groups. The first group will receive Pazopanib. The second group will receive no intervention, only best supportive care. Patients progressing in the second group may possibly receive compassionate treatment by Pazopanib.

Trial Links

Trial Results

Drug Information

Votrient.com website
 
Highlights of prescribing info and full text of prescribing information (PDF)
 
Commitment to Access - GSK's patient assistance program for access to drugs
 
The small-molecule VEGF receptor inhibitor pazopanib (GW786034B) targets both tumor and endothelial cells in multiple myeloma
 
FDA approves GSK's Votrient for advanced renal cell cancer (GSK website)
 
FDA presentation: Key new drug applicant information
 
Votrient on rxlist.com
 
Pazopanib-induced hyperbilirubinemia (liver problems) is associated with Gilbert's syndrome UGT1A1 polymorphism - Full text article
 
In the Pipeline: Positive Early Results with Pazopanib in Bladder Cancer
 
Pazopanib reveals a role for tumor cell B-Raf in the prevention of HER2+ breast cancer brain metastasis
 
Pazopanib for the Treatment of Patients with Advanced Renal Cell Carcinoma (full text article, with good discussion of side effects)
 
Help for patients without drug coverage
 
Pazopanib IC50 Table
 
Suppression of the Nitric Oxide Pathway in Metastatic Renal Cell Carcinoma Patients Receiving Vascular Endothelial Growth Factor–Signaling Inhibitors (PDF)
 
Medical News TODAY article - FDA approves GSK's VOTRIENT (TM) for advanced renal cell cancer
 
FDA approves Votrient® for treatment of patients with certain types of advanced soft tissue sarcoma
 
Votrient - Important changes to frequency of liver test monitoring (PDF)
 

Trial Sites

Name
Address
City
State
Zip
Country
28 rue Laennec
Lyon
Rhone
69373
France
229 Cours Argonne
Bordeaux
Gironde
33076
France
Dijon
France
Lille
Nord
59020
France
Marseille
Bouches du Rhone
13273
France
Marseille
13000
France
Nancy
57000
France
Nantes
France
Paris
75571
France
Paris
75020
France
Reimes
France
Saint Priest en Jarez
Loire
42270
France
Villejuif
Val de Narne
94805
France