Ignite Creation Date:
2024-05-05 @ 9:18 PM
Last Modification Date:
2024-10-26 @ 10:02 AM
Study NCT ID:
NCT00856791
Status:
COMPLETED
Last Update Posted:
2017-07-21
First Post:
2009-03-04
Brief Title:
Effect of 2-h Infusion of ON 01910Na in Ovarian Cancer Patients
Sponsor:
Traws Pharma Inc
Organization:
Traws Pharma Inc
Study Overview
Official Title:
Phase II Single-arm Study of ON 01910Na by 2-hr Infusion in Patients With Recurring Platinum-resistant Ovarian Cancer
Status:
COMPLETED
Status Verified Date:
2017-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
ON 01910Na 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 01910Na has an effect on progression free survival rates in patients with platinum-resistant ovarian cancer ON 01910Na 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
Detailed Description:
This is a Phase II single arm study of ON 01910Na 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 01910Na 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 01910Na Toxicity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events NCI CTCAE v30 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 01910Na 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
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 01910Na 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 01910Na Toxicity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events NCI CTCAE v30 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 01910Na 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None