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Indian J Cancer ; 2014 Jan-Mar; 51(1): 40-44
Article Dans Anglais | IMSEAR | ID: sea-154282

Résumé

CONTEXT: Rigosertib, a potent, multi-kinase inhibitor that selectively induces mitotic arrest and apoptosis in cancer cells and is non-toxic to normal cells, is being developed for the treatment of solid tumors and hematological malignancies. AIMS: To determine the safety, doselimiting toxicities, and clinical activity of rigosertib administered by 2-, 4-, or 8-hour continuous IV infusion twice-a-week for 3 weeks out of a 4-week cycle in patients with advanced solid tumor or hematological malignancies; and to confirm the safety and tolerability of the recommended phase 2 dose (RPTD). SETTINGS AND DESIGN: Phase 1, open-label, dose-escalation study in men and women ≥18 years of age. MATERIALS AND METHODS: An escalation phase optimized the duration of infusion (2, 4, or 8 hours) of 3200 mg rigosertib twice-a-week for 3 weeks of a 4-week cycle; an expansion phase confirmed the maximum tolerated dose (MTD). STATISTICAL ANALYSIS USED: All data summaries were descriptive. PK parameters were estimated using compartmental analysis. RESULTS: 25 patients (16 male, 9 female, 26- 66 years, all Asian) were treated with rigosertib, 16 in the escalation phase; 9 in the expansion phase. MTD was determined to be 3200 mg as a 4-hour infusion and 2400 mg over 4 hours was declared to be the RPTD. Best response was stable disease in 5 of 14 evaluable patients, with a mean (range) of 90 (43-108) days. CONCLUSIONS: 2400 mg rigosertib as a 4-hour infusion was identified as the RPTD. Five patients achieved stable disease lasting 6-16 weeks.


Sujets)
Adulte , Sujet âgé , Antinéoplasiques/administration et posologie , Antinéoplasiques/pharmacocinétique , Études de cohortes , Relation dose-effet des médicaments , Femelle , Études de suivi , Glycine/administration et posologie , Glycine/analogues et dérivés , Glycine/pharmacocinétique , Humains , Perfusions veineuses , Mâle , Dose maximale tolérée , Adulte d'âge moyen , Stadification tumorale , Tumeurs/traitement médicamenteux , Tumeurs/métabolisme , Tumeurs/anatomopathologie , Pronostic , Sulfones/administration et posologie , Sulfones/pharmacocinétique , Facteurs temps , Distribution tissulaire
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