TRIAL DETAIL

Dasatinib as First-Line Therapy in Treating Patients With Gastrointestinal Stromal Tumors

Drug:	Dasatinib (BMS-354825)
Trial Name:	Dasatinib as First-Line Therapy in Treating Patients With Gastrointestinal Stromal Tumors
NCT#:	NCT00568750
Conditions:	Gastrointestinal Stromal Tumor
Status:	Completed
Phase:	2	Start Date 01/22/2008	Age of Trial (yrs) 16.8
Treatment Phase:	First-line
Drug Category:	KIT/PDGFRA inhibitor + SRC inhibitor
Strategy:	Block KIT + Block KIT Signal Path
Trial Type:	Specifically GIST and only GIST
Other Protocol IDs:	CDR0000577496, SWS-SAKK-56/07, EU-20789, EUDRACT-2007-002047-24
Sponsor:	Swiss Group for Clinical Cancer Research
Patient Contact:	See site contact info below
Contact email:
Contact Phone:
Randomized:
IV or Oral:	Oral
Trial Notes:	This phase II trial studied how well dasatinib works as first-line therapy in treating patients with gastrointestinal stromal tumors. Final trial results have been reported (see link in Trial Results).

Trial Links

Trial Results

Long-term outcome of dasatinib first-line treatment in gastrointestinal stromal tumor: A multicenter, 2-stage phase 2 trial (Swiss Group for Clinical Cancer Research 56/07) Full-text article

Drug Information

Dasatinib inhibits KIT D816V mutation-an imatinib-resistant activating mutation

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
Centre Hospitaleir Universitaire Vaudois		Lausanne		CH-1011	Switzerland
Helsinki University Central Hospital		Helsinki		FIN-00029	Finland
Centre Paul Strauss		Strasbourg		67065	France
Hopital Edouard Herriot		Lyon		69008	France
Institut Bergonie	229 Cours Argonne	Bordeaux	Gironde	33076	France
Institut Gustave Roussy		Villejuif	Val de Narne	94805	France
Universitatsklinikum Essen, West Germany Cancer Center	Hufelandstr. 55	Essen		45122	Germany
City Hospital Triemli		Zurich		CH-8063	Switzerland
Hopital Cantonal Universitaire de Geneve		Geneva		CH-1211	Switzerland
Universitaetsspital-Basel		Basel		CH-4031	Switzerland
Kantonsspital Baden		Baden		CH-5404	Switzerland
Kantonsspital Bruderholz		Bruderholz		CH-4101	Switzerland
Kantonsspital Graubuenden		Chur		CH-7000	Switzerland
Kantonsspital Liestal		Liestal		CH-4410	Switzerland
Onkozentrum - Klinik im Park		Zurich		CH-8002	Switzerland
Saint Claraspital		Basel		CH-4016	Switzerland
UniversitaetsSpital Zuerich		Zurich		CH-8091	Switzerland
Kantonsspital - St Gallen		St. Gallen		CH-9007	Switzerland