Phase II trial of vatalanib in patients with advanced or metastatic pancreatic adenocarcinoma after first-line gemcitabine therapy (PCRT O4-001)
Autor: | Dragovich, T, Laheru, D, Dayyani, F, Bolejack, V, Smith, L, Seng, J, Burris, H, Rosen, P, Hidalgo, M, Ritch, P, Baker, AF, Raghunand, N, Crowley, J, Von Hoff, DD |
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Rok vydání: | 2014 |
Předmět: |
Adult
Male Pyridines Clinical Trials and Supportive Activities Tyrosine kinase inhibitor Enzyme-Linked Immunosorbent Assay Adenocarcinoma Deoxycytidine Pancreatic Cancer Rare Diseases Clinical Research Antineoplastic Combined Chemotherapy Protocols 80 and over Humans Oncology & Carcinogenesis Neoplasm Metastasis 6.2 Cellular and gene therapies Neoplasm Staging Aged Cancer Tumor Pain Research Evaluation of treatments and therapeutic interventions Pharmacology and Pharmaceutical Sciences Middle Aged Prognosis Gemcitabine Pancreatic Neoplasms Survival Rate Neoplasm Recurrence Orphan Drug Local 6.1 Pharmaceuticals Vatalinib Second-line treatment Phthalazines Female Digestive Diseases Pancreatic adenocarcinoma Biomarkers Follow-Up Studies |
Zdroj: | Cancer chemotherapy and pharmacology, vol 74, iss 2 |
Popis: | PurposeVatalanib (PTK 787/ZK22584) is an oral poly-tyrosine kinase inhibitor with strong affinity for platelet-derived growth factor and vascular endothelial growth factor (VEGF) receptors. We conducted an open-label, phase II multicenter therapeutic trial investigating the efficacy and tolerability of vatalanib in patients with metastatic or advanced pancreatic cancer who failed first-line gemcitabine-based therapy.MethodsVatalanib treatment consisted of a twice daily oral dosing using a "ramp-up schedule," beginning with 250 mg bid during week 1,500 mg bid during week 2, and 750 mg bid on week three and thereafter. The primary objective of this study was to evaluate the 6-month survival rate.ResultsSixty-seven patients were enrolled. The median age was 64, and 66% (N = 43) had only one prior regimen. Common grade 3/4 adverse events included hypertension (20%; N = 13), fatigue (17%; N = 11), abdominal pain (17%; N = 11), and elevated alkaline phosphatase (15%; N = 10). Among the 65 evaluable patients, the 6-month survival rate was 29% (95% CI 18-41%) and the median progression-free survival was 2 months. Fifteen patients survived 6 months or more. Two patients had objective partial responses, and 28% of patients had stable disease. Changes in biomarkers including soluble VEGF and vascular endothelial growth factor receptor did not correlate with response to drug.ConclusionVatalanib was well tolerated as a second-line therapy and resulted in favorable 6-month survival rate in patients with metastatic pancreatic cancer, compared with historic controls. |
Databáze: | OpenAIRE |
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