A phase 2 study of vatalanib in metastatic melanoma patients

Abstract Background A phase 2 study of vatalanib (PTK787/ZK222584) an oral tyrosine kinase inhibitor of VEGFR 1, 2 and 3 was undertaken in patients with metastatic melanoma. Methods Adults with pathologically confirmed metastatic melanoma, WHO Performance status 0–2, and adequate haematological, hepatic and renal function, were treated with vatalanib until disease progression. The trial used Fleming’s single stage design. Results Tumour control rate (CR + PR + SD) was 35% at 16 weeks, with objective response seen in only 1 patient. Median progression-free survival was 1.8 months (95% CI 1.8–3.7 months) and median overall survival was 6.5 months (95% CI 3.9–10.2 months). Conclusion Vatalanib stabilised disease in a proportion of patients, although overall survival was disappointing.