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Published on: January 25, 2015
A phase 2 study of vatalanib in metastatic melanoma patients
Natalie Cook1, Bristi Basu, Swethajit Biswas
1Cambridge University Hospitals NHS Foundation Trust (Addenbrookes Hospital), Cambridge, UK.
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.
Insights
Vatalanib, an oral tyrosine kinase inhibitor, showed a 35% tumor control rate in metastatic melanoma patients. However, overall survival was disappointing, indicating limited efficacy for this treatment.
Area of Science:
- Oncology
- Pharmacology
- Clinical Trials
Background:
- Investigated vatalanib (PTK787/ZK222584), an oral tyrosine kinase inhibitor targeting VEGFR 1, 2, and 3.
- Focused on patients with metastatic melanoma.
Purpose of the Study:
- To evaluate the efficacy and safety of vatalanib in metastatic melanoma.
- To determine tumor control rate and survival outcomes.
Main Methods:
- Phase 2 clinical trial with Fleming's single-stage design.
- Adult patients with metastatic melanoma, WHO Performance Status 0-2, and adequate organ function were enrolled.
- Treatment continued until disease progression.
Main Results:
- Tumor control rate (CR+PR+SD) at 16 weeks was 35%.
- Only one patient achieved an objective response.
- Median progression-free survival was 1.8 months; median overall survival was 6.5 months.
Conclusions:
- Vatalanib demonstrated disease stabilization in a subset of patients.
- The overall survival outcomes were disappointing, suggesting limited clinical benefit.
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