TRIAL DETAIL

A Phase I/II Study of Sunitinib Malate (SU011248) In Patients With Gastrointestinal Stromal Tumor (GIST)

Drug:
Trial Name:
A Phase I/II Study of Sunitinib Malate (SU011248) In Patients With Gastrointestinal Stromal Tumor (GIST)
NCT#:
Conditions:
Gastrointestinal Stromal Tumor
Status:
Completed
Phase:
1
Start Date 01/01/2005
Age of Trial (yrs) 19.9
Treatment Phase:
Drug Category:
KIT/PDGFRA inhibitor
Strategy:
Block KIT
Trial Type:
Specifically GIST and only GIST
Other Protocol IDs:
A6181045, JapicCTI-070386
Sponsor:
Pfizer
Patient Contact:
Contact email:
Contact Phone:
Randomized:
IV or Oral:
Oral
Trial Notes:
This was the phase I/II trial for Sutent. Based on the results of this trial, a randomized phase III trial was started and eventually led to the approval of Sutent for Gleevec-resistant GIST. Only in Japan

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

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