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YAP, T. A; CORTES-FUNES, H; CORONADO, C; ALFARO, V; SOTO-MATOS, A; FERNANDEZ-TERUEL, C; SIGUERO, M; TABERNERO, J. M; PAZ-ARES, L; DE BONO, J. S; LOPEZ-MARTIN, J. A; SHAW, H; RODRIGUEZ, R; OLMOS, D; LAL, R; FONG, P. C; TAN, D. S; HARRIS, D; CAPDEVILA, J
British journal of cancer, 04/2012, Letnik: 106, Številka: 8Journal Article
PM00104 binds guanines at DNA minor grooves, impacting DNA replication and transcription. A phase I study was undertaken to investigate safety, dose-limiting toxicities (DLTs), recommended phase II dose (RP2D), pharmacokinetics (PKs) and preliminary antitumour activity of PM00104 as a 1- or 3-h infusion three-weekly. Patients with advanced solid tumours received PM00104 in a dose escalation trial, as guided by toxicity and PK data. A total of 47 patients were treated; 27 patients on the 1-h schedule (0.23-3.6 mg m(-2)) and 20 patients on the 3-h schedule (1.8-3.5 mg m(-2)). Dose-limiting toxicities comprised reversible nausea, vomiting, fatigue, elevated transaminases and thrombocytopenia, establishing the 1-h schedule RP2D at 3.0 mg m(-2). With the 3-h schedule, DLTs of reversible hypotension and neutropenia established the RP2D at 2.8 mg m(-2). Common PM00104-related adverse events at the RP2D comprised grade 1-2 nausea, fatigue and myelosuppression. In both schedules, PKs increased linearly, but doses over the 1-h schedule RP2D resulted in higher than proportional increases in exposure. A patient with advanced urothelial carcinoma had RECIST shrinkage by 49%, and three patients had RECIST stable disease ≥6 months. PM00104 is well tolerated, with preliminary evidence of antitumour activity observed. The 1-h 3-weekly schedule is being assessed in phase II clinical trials.
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JCR | SNIP | JCR | SNIP | JCR | SNIP | JCR | SNIP |
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