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

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

Gastrointestinal Stromal Tumor

Completed

2

Start Date 09/01/2004

Age of Trial (yrs) 20.2

Gleevec-resistant

KIT/PDGFRA inhibitor+ VEGF inhibitor (antibody)

Block KIT + Block blood vessel growth

Specifically GIST and only GIST

CPTK787 A2401/300267, GIST PTK787/ZK222584

Helsinki University, Bayer

Heikki Joensuu, MD

heikki.joensuu@hus.fi

+358-9-471-73208

Oral

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.