TRIAL DETAIL

Trial of Dasatinib in Advanced Sarcomas

Drug:
Trial Name:
Trial of Dasatinib in Advanced Sarcomas
NCT#:
Conditions:
Gastrointestinal Stromal Tumor
Status:
Ongoing, but not recruiting
Phase:
2
Start Date 05/01/2007
Age of Trial (yrs) 17
Treatment Phase:
Gleevec-resistant
Drug Category:
KIT/PDGFRA inhibitor + SRC inhibitor
Strategy:
Block KIT + Block KIT Signal Path
Trial Type:
Specifically GIST plus other cancers
Other Protocol IDs:
SARC009
Sponsor:
SARC Bristol-Myers Squibb
Patient Contact:
Kathleen Granlund kegranlund@sarctrials.org 734-930-7607
Contact email:
Contact Phone:
Randomized:
IV or Oral:
Oral
Trial Notes:
Treatment: Subjects take Dasatinib twice daily by mouth for 28 days per 28 day cycle.

AS OF 2/2/2010 GIST PATIENTS ARE NO LONGER ELIGIBLE FOR THIS TRIAL


Subjects will be seen for interim medical history, physical exam and laboratory studies prior to each cycle. Subjects will undergo tumor imaging every 2 months (8 weeks) for the first 6 months and approximately every 3 months thereafter while on treatment.

A blood sample for collection of specimens with which to later study serum level of Dasatinib and effects on biomarkers of drug activity will be obtained approximately 2 to 4 weeks after the start of treatment.

Central collection of archival tumor with which to later study the frequency of expression and/or mutation of kinases inhibited by dasatinib will occur.

Subjects will be followed for approximately every 3 months until 2 years from registration and then approximately yearly until 5 years from registration.

Trial Links

 
 

Trial Results

 
 

Drug Information

Dasatinib inhibits KIT D816V mutation-an imatinib-resistant activating mutation
 
Sprycel.com
 
Sprycel reimbursement support (Destination Access)
 
Sprycel prescribing information (PDF)
 
Dasatinib inhibits PDGFRA D842V mutation - Debiec-Rychter - 2008
 
Dasatinib inhibits activity of wild-type, juxtamembrane and activation loop mutant KIT (Heinrich, et al)
 
FDA drug information page (technical information about the drug approval, etc)
 
Effect of a proton pump inhibitor on the pharmacokinetics of imatinib (mentions that dasatinib levels are highly affected by PPIs).
 
The occurrence and management of fluid retention associated with TKI therapy in CML, with a focus on dasatinib
 
FDA: Increased Pulmonary Arterial Hypertension Risk Seen With Dasatinib
 
FDA website: Sprycel (dasatinib): Drug Safety Communication - Risk of Pulmonary Arterial Hypertension
 
Severe adverse events associated with the use of second-line BCR/ABL tyrosine kinase inhibitors: preferential occurrence in patients with comorbidities
 
Disintegration of chemotherapy tablets (including dasatinib) for oral administration in patients with swallowing difficulties
 
Activity of dasatinib against L576P KIT mutant melanoma: Molecular, cellular, and clinical correlates
 

Trial Sites

Name
Address
City
State
Zip
Country
Little Rock
AR
72202
USA
875 Blake Wilbur Drive
Palo Alto
CA
94304
USA
1500 E. Duarte Road
Duarte
CA
91010
USA
8700 Beverly Blvd.
Los Angeles
CA
90048
USA
110 Irving St
Washington
DC
20010
USA
1365C Clifton Road
Atlanta
GA
30322
USA
2003 Lincoln Way
Coeur d'Alene
ID
83814
USA
1700 Luther Ln
Park Ridge
IL
60068
USA
535 Barnhill Drive
Indianapolis
IN
46202
USA
Baltimore
MD
21231
USA
55 Fruit Street
Boston
MA
02114
USA
450 Brookline Ave
Boston
MA
02215-5450
USA
1500 East Medical Center Dr
Ann Arbor
MI
48109
USA
Omaha
NB
68114
USA
Philadelphia
PA
19106
USA
333 Cottman Ave
Philadelphia
PA
19111
USA
Pittsburgh
PA
15232
USA
1505 Holcombe Blvd.
Houston
TX
77030
USA
2811 Wilshire Blvd
Santa Monica
CA
90403
USA
Iowa City
IA
52242
USA