TRIAL DETAIL

SU011248 in Treating Patients With Malignant Gastrointestinal Stromal Tumor

Drug:	Sunitinib
Trial Name:	SU011248 in Treating Patients With Malignant Gastrointestinal Stromal Tumor
NCT#:	NCT00085618
Conditions:	Gastrointestinal Stromal Tumor
Status:	Completed
Phase:	3	Start Date 03/01/2004	Age of Trial (yrs) 20.7
Treatment Phase:	Gleevec-resistant
Drug Category:	KIT/PDGFRA inhibitor
Strategy:	Block KIT
Trial Type:	Specifically GIST and only GIST
Other Protocol IDs:	CDR000037083, MSKCC-04028, PFIZER-A6181004, UCLA-0311021-01
Sponsor:	Memorial Sloan-Kettering UCLA - Jonsson, NCI
Patient Contact:
Contact email:
Contact Phone:
Randomized:	Randomized
IV or Oral:	Oral
Trial Notes:	This is a spin-off of the original Phase III.

Trial Links

Clinicaltrials.gov listing

Trial Results

Updated phase III results-ASCO abstract and presentation

Detailed analysis of survival and safety with sunitinib (SU) in a worldwide treatment-use trial of patients with advanced GIST

Summary of Sutent phase 3 trial results

Drug Information

All about Sutent (LRG website)

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
Memorial Sloan Kettering	1275 York Ave	New York	NY	10065	USA
UCLA's Jonsson Comprehensive Cancer Center	10945 Le Conte Ave.	Los Angeles	CA	90095	USA