TRIAL DETAIL

A Study of the Combination of Sirolimus and Sutent in Patients With Advanced Solid Tumors That Are Non-Curable With Standard Therapy

Drug:
Trial Name:
A Study of the Combination of Sirolimus and Sutent in Patients With Advanced Solid Tumors That Are Non-Curable With Standard Therapy
NCT#:
Conditions:
Solid Tumors
Status:
Ongoing, but not recruiting
Phase:
1
Start Date 02/01/2006
Age of Trial (yrs) 18.2
Treatment Phase:
Gleevec-resistant
Drug Category:
KIT/PDGFRA inhibitor
Strategy:
Block KIT
Trial Type:
GIST not specified. GIST patient enrollment unknown.
Other Protocol IDs:
0510000723
Sponsor:
Yale University Pfizer
Patient Contact:
Linda Rink, R.N. Sally Ruta, B.S., LPN
Contact email:
Linda.Rink@yale.edu
Contact Phone:
203 785-6128
Randomized:
IV or Oral:
Trial Notes:
Primary Outcome Measures:

* To determine the maximum tolerated dose of sirolimus when combined with a standard dose and schedule of Sutent(R)
* To obtain preliminary experience with dynamic MR imaging of tumor blood flow using the combination of Sutent(R) and sirolimus
* To provide preliminary data on dose effects of the combination on serum levels of VEGF and circulating endothelial cells
* To obtain preliminary information on the efficacy of Sutent(R)in combination with sirolimus in treating malignancies using RECIST criteria

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
333 Cedar St
New Haven
CT
06510
USA