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Year : 2014  |  Volume : 51  |  Issue : 1  |  Page : 40-44

Phase 1 dose escalation study of rigosertib by 2-, 4-, or 8-hour infusion twice-weekly in patients with advanced cancer

1 Department of Medical Oncology, Jaslok Hospital and Research Centre, 15 Dr. Deshmukh Marg, Pedder Road, Mumbai, Maharashtra, India
2 Rajiv Gandhi Cancer Institute and Research Centre, Sector 5, Rohini, New Delhi, India
3 Department of Medical Oncology, Nizam's Institute of Medical Sciences, Panjagutta, Hyderabad, India
4 Department of Onconova Therapeutics, Inc, 375 Pheasant Run Newtown, PA 18940, USA

Correspondence Address:
D Raghunadharao
Department of Medical Oncology, Nizam's Institute of Medical Sciences, Panjagutta, Hyderabad
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Source of Support: The funding for this clinical study was provided by Onconova Therapeutics, Inc., Conflict of Interest: None

DOI: 10.4103/0019-509X.134617

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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, dose-limiting 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.


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