A Phase I study of the safety, pharmacokinetics and efficacy of navitoclax plus docetaxel in patients with advanced solid tumors.
Future Oncol
; 17(21): 2747-2758, 2021 Jul.
Article
em En
| MEDLINE
| ID: mdl-33849298
ABSTRACT
Aim:
This Phase I study investigated safety of navitoclax and docetaxel in patients (n = 41) with advanced solid tumors. Patients &methods:
Two navitoclax plus docetaxel dosing schedules (21 and 28 days) were evaluated. Maximum tolerated dose, dose-limiting toxicities and preliminary antitumor activity were assessed.Results:
Ten (24%) patients experienced dose-limiting toxicities; dose-escalation cohorts n = 7 (21-day schedule n = 5; 28-day schedule n = 2) and 21-day expanded safety cohort n = 3. Navitoclax 150-mg days 1-5 every 21 days with docetaxel 75 mg/m2 day 1 was the maximum tolerated dose and optimal schedule. Adverse events included thrombocytopenia (63%), fatigue (61%), nausea (59%) and neutropenia (51%). Four confirmed partial responses occurred.Conclusion:
Navitoclax 150-mg orally once/day was safely administered with docetaxel. Myelosuppression limited dose escalation; antitumor activity was observed. Clinical trial registration NCT00888108 (ClinicalTrials.gov).Palavras-chave
Texto completo:
1
Base de dados:
MEDLINE
Assunto principal:
Sulfonamidas
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Protocolos de Quimioterapia Combinada Antineoplásica
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Docetaxel
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Compostos de Anilina
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Neoplasias
Tipo de estudo:
Clinical_trials
Limite:
Adult
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Aged
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Aged80
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Female
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Humans
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Male
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Middle aged
Idioma:
En
Ano de publicação:
2021
Tipo de documento:
Article