Phase II Single-arm Study of ON 01910.Na by 2-hr Infusion in Patients With Recurring Platinum-resistant Ovarian Cancer
This is a Phase II single arm study of ON 01910.Na to be administered as a 2-hour infusion
biweekly to patients with progressive ovarian cancer resistant to platinum-based therapy.
The primary objective is to evaluate progression-free survival (PFS). The secondary
objectives are to document other measures of outcome [objective response rate (ORR),
duration of response, duration of stable disease, and overall survival (OS)], and
tolerability of study drug.
Thirty-seven (37) patients with progressive ovarian cancer resistant to platinum-based
therapy will be enrolled in a single arm study and treated with ON 01910.Na administered as
a 2-hour infusion on Days 1, 4, 8, 11, 15 and 18 of a 28-day cycle. Patients will be treated
until disease progression or withdrawal for other causes (unacceptable toxicity, patient or
investigator decision) with ON 01910.Na. Toxicity will be graded according to the National
Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE v3.0).
Progression-free survival, objective response, duration of response, and duration of stable
disease will be assessed using RECIST (Response Evaluation Criteria in Solid Tumor)
guidelines, as well as overall survival. Grades 3 and 4 hematologic toxicities, grade >2
non-hematologic toxicities will be monitored. A futility analysis will be performed after 17
evaluable patients are enrolled and evaluated for overall objective response. If 3 or fewer
objective response (CR and PR) are observed, the study will be closed to further accrual and
deemed futile. An extension study for an additional 25 weeks with complete monitoring will
be considered for patients who have not progressed by week 25.
The ON 01910.Na dose to be used in this study (2-hour infusions of 2400 or 3200 mg twice
weekly for 3 weeks of a 4-week cycle) was selected based on the maximum tolerated doses and
activities documented in phase 1 protocols.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Progression Free Survival
Progression-free survival, defined as the number of days from the first day of study drug dosing to the day of documented disease progression or death, as assessed using RECIST (Response Evaluation Criteria in Solid Tumors) guidelines according to Therasse P, Arbuck SF, Eisenhauer EA, et al. (2000) J Natl Cancer Inst. 92:205-216. Progressive disease is defined as at least a 20% increase in the sum of the longest diameter (LD)of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.
Gregory P. Sutton, MD
St. Vincent Gynecologic Oncology, Indianapolis, IN
United States: Food and Drug Administration
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