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ON 01910.Na has undergone preclinical and clinical phase I studies showing activity in patients with progressing ovarian cancer resistant to platinum-based chemotherapies. This study will look at a larger population of patients to determine whether treatment with ON 01910.Na has an effect on progression free survival rates in patients with platinum-resistant ovarian cancer. ON 01910.Na will be given as an intravenous infusion over 2 hours on days 1, 4, 8, 11, 15, and 18 of a 28-day cycle. Patients will be treated for 6 or more cycles.
Full description
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.
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Inclusion criteria
Exclusion criteria
Evidence of complete or partial bowel obstruction.
Need for IV hydration or Total Parenteral Nutrition.
Inability to comply with study and/or follow-up procedures.
Life expectancy of less than 12 weeks.
Prior radiotherapy to greater than one third of hematopoietic sites.
Uncontrolled intercurrent illness including, but not limited to symptomatic congestive heart failure, unstable angina pectoris or cardiac arrhythmia.
Active infection not adequately responding to appropriate therapy.
Hyponatremia (defined as serum sodium value of <134 mEq/L).
Total bilirubin ≥ 1.5 mg/dL not related to hemolysis or Gilbert's disease, AST/ALT or alkaline phosphatase ≥ 2 X ULN.
Serum creatinine ≥ 2.0 mg/dL.
ANC < 1500/mm3, platelets < 100,000/mm3; hemoglobin less than 9 g/dL.
Ascites requiring active medical management including paracentesis for more than twice a month.
Women patients who are pregnant or lactating or have a positive serum βHCG pregnancy test at screening.
Major surgery without full recovery or major surgery within 3 weeks of ON 01910.Na treatment start.
Uncontrolled hypertension (defined as a systolic pressure ≥ 160 and/or a diastolic pressure ≥ 110).
New onset seizures (within 3 months prior to the first dose of ON 01910.Na) or poorly controlled seizures.
Brain metastases including any of the following:
Any concurrent and/or within 4 weeks of the first dose of study drug investigational agent or chemotherapy, radiotherapy or immunotherapy.
Psychiatric illness/social situations that would limit the patient's ability to tolerate and/or comply with study requirements.
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1 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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