Fernández ÁJD, García VY, Ríos JRO, López SA, Rodríguez RCR, Rodríguez FY, Valenzuela SC

Language: Spanish
References: 18
Page: 236-248
PDF size: 215.23 Kb.

ABSTRACT

Introduction: CIGB-300 is a synthetic peptide capable of producing apoptosis in tumor cells.
Objectives: To explore the safety of CIGB-300 administered intravenously in patients with hematological malignancies (Registry No. 05.013.12.B).
Methodology: A multicenter, non-randomized, adaptive, with an only treatment group (intravenous administration of the investigational product and dose escalation in the same patient), phase I clinical trial was conducted. Adverse events were classified according to the version 4.03 of "Common Terminology Criteria for Adverse Events". Patients aged 18 years or older were selected, not candidates for bone marrow transplantation, with refractory or relapsed acute leukemias, acute myeloblastic leukemia of elderly, and myelodysplastic syndromes with blast excess, who had ECOG ≤ 3 and agreed to participate in the investigation. We considered as exclusion criteria: acute promyelocytic leukemia, decompensated chronic diseases, severe allergic history, pregnancy, postpartum and breastfeeding. For quantitative variables, measures of central tendency and qualitative distribution of frequencies were estimated.
Results: Of 10 patients included 6 received treatment with five dose levels. Ninety four types of adverse events were present, most systemic, with 619 notifications. Localized itching and rash were the most common events, followed by high blood pressure. The events occurred more frequently on the first day of each cycle and no increase was detected when the dose of the product was rised. Minor events were 87,7 % and 61,6 % with probable causality. Fifteen serious adverse events occurred, but only one was related to the administration of CIGB 300.
Conclusions: Intravenous administration of CIGB-300 was safe and well tolerated. Dose escalation did not increase the toxicity of the product.

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