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Invest New Drugs ; 33(1): 194-200, 2015 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-25342141

RESUMO

PURPOSE: This Phase I, open-label, single-arm, dose-escalation study aimed to evaluate the safety and tolerability of the insulin-like growth factor (IGF-I/II) neutralizing antibody, MEDI-573, in Japanese patients with advanced solid tumours refractory to standard therapy or for which no standard therapy exists. The pharmacokinetics, pharmacodynamics and antitumour activity of MEDI-573 were also evaluated. METHODS: Three cohorts of patients received MEDI-573 in escalating order: cohort 1, 5 mg/kg on Day 1, 8 and 15; cohort 2, 15 mg/kg on Day 1, 8 and 15; cohort 3, 45 mg/kg on Day 1, of 21-day cycles. RESULTS: Ten patients who received at least one dose of MEDI-573 were evaluated. The median number of treatment cycles was 2.0 (range 1-6) and the median number of MEDI-573 doses received was 4.0 (range 1-17). The most commonly reported drug-related adverse events were fatigue (n = 2 patients), pyrexia (n = 2), diarrhoea (n = 2) and electrocardiogram QT prolongation (n = 2). No patients experienced a dose-limiting toxicity. Pharmacokinetics of MEDI-573 were linear with a dose-dependent increase. There were no complete or partial responses; four patients had an overall best response of stable disease. CONCLUSIONS: MEDI-573 is well tolerated at the doses investigated.


Assuntos
Anticorpos Neutralizantes , Antineoplásicos , Fator de Crescimento Insulin-Like II/antagonistas & inibidores , Fator de Crescimento Insulin-Like I/antagonistas & inibidores , Neoplasias/tratamento farmacológico , Idoso , Anticorpos Monoclonais Humanizados , Anticorpos Neutralizantes/efeitos adversos , Anticorpos Neutralizantes/sangue , Anticorpos Neutralizantes/farmacologia , Anticorpos Neutralizantes/uso terapêutico , Antineoplásicos/efeitos adversos , Antineoplásicos/sangue , Antineoplásicos/farmacologia , Antineoplásicos/uso terapêutico , Povo Asiático , Anticorpos Amplamente Neutralizantes , Feminino , Humanos , Fator de Crescimento Insulin-Like I/imunologia , Fator de Crescimento Insulin-Like II/imunologia , Masculino , Pessoa de Meia-Idade , Neoplasias/metabolismo , Resultado do Tratamento
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