TRIAL DETAIL

PTK787/ZK222584 in the Treatment of Metastatic Gastrointestinal Stromal Tumors Resistant to Imatinib

Drug:
Trial Name:
PTK787/ZK222584 in the Treatment of Metastatic Gastrointestinal Stromal Tumors Resistant to Imatinib
NCT#:
Conditions:
Gastrointestinal Stromal Tumor
Status:
Completed
Phase:
2
Start Date 09/01/2004
Age of Trial (yrs) 17.3
Treatment Phase:
Gleevec-resistant
Drug Category:
KIT/PDGFRA inhibitor+ VEGF inhibitor (antibody)
Strategy:
Block KIT + Block blood vessel growth
Trial Type:
Specifically GIST and only GIST
Other Protocol IDs:
CPTK787 A2401/300267, GIST PTK787/ZK222584
Sponsor:
Helsinki University, Bayer
Patient Contact:
Heikki Joensuu, MD
Contact email:
heikki.joensuu@hus.fi
Contact Phone:
+358-9-471-73208
Randomized:
IV or Oral:
Oral
Trial Notes:
RESULTS: All 15 patients enrolled were eligible; two (13%) achieved partial response (PR), eight (53%) had stable disease (SD) >/=3 months, and five (33%) progressed. The clinical benefit rate (PR + SD) was 67% (95% CI 38% to 86%). Median time to progression was 8.5 months (range 0.9-24.8+ months). Three patients had not progressed at the time of analysis, including one PR at 24.8 months and two SDs at 16.6 and 18.6 months on treatment. PTK/ZK was generally well tolerated. CONCLUSION: PTK/ZK 1250 mg p.o. once daily is active and well tolerated in patients with imatinib-resistant GIST.

Trial Links

 

Trial Results

 
 
 

Drug Information

PTK787/ZK 222584, a Specific Vascular Endothelial Growth Factor-Receptor Tyrosine Kinase Inhibitor, Affects the Anatomy of the Tumor Vascular Bed and the Functional Vascular Properties as Detected by Dynamic Enhanced Magnetic Resonance Imaging
 

Trial Sites

Name
Address
City
State
Zip
Country
Helsinki
FIN-00029
Finland
via Giacomo
Milan
20133
Italy