Safety and Efficacy Clinical Study of SNS-595 in Patients With Platinum-Resistant Ovarian Cancer
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|ClinicalTrials.gov Identifier: NCT00408603|
Recruitment Status : Completed
First Posted : December 7, 2006
Results First Posted : June 28, 2017
Last Update Posted : July 27, 2017
|Condition or disease||Intervention/treatment||Phase|
|Epithelial Ovarian Cancer||Drug: Voreloxin Injection||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||183 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 2 Open-Label, Multicenter Study of SNS-595 Injection in Patients With Platinum-Resistant Ovarian Cancer|
|Actual Study Start Date :||December 20, 2006|
|Actual Primary Completion Date :||June 9, 2010|
|Actual Study Completion Date :||June 9, 2010|
Experimental: All study patients
All patients will receive voreloxin injection
Drug: Voreloxin Injection
All patients in initial dose level receive voreloxin injection at 48 mg/m2 administered once every 21 days up to 6 cycles. Subsequent levels are of 60 mg/m2 or 75 mg/m2 every 28 days up to 6 cycles if safety acceptable.
Other Name: SNS-595, vosaroxin, Qinprezo
- Overall Response Rate (CR+PR) Per Investigator Assessment Based on GOG-RECIST Criteria [ Time Frame: GOG-RECIST assessment obtained on cycle2, 4 and 6 Day 21for patients treated with 48 mg/m2 SNS-595 and Day 28 for patients treated with 60 mg/m2, through 28 (±14) days afte the last treatment at the end of safety follow up period ]Response rate was calculated per investigator's tumor assessment based on GOG-RECIST, which includes radiographic imaging, physical examination results, and CA-125 levels. No independent review of CT scans (lesion assessments) was performed. CR: disappearance of all target and nontarget lesions and no evidence of new lesions documented by two disease assessments at least 4 weeks apart. Normalization of CA125, if elevated at baseline, is required for ovarian carcinoma studies. PR is >= 30% decrease in the sum of LD of all target measurable lesions taking as reference the baseline sum of LD. There can be no unequivocal progression of nontarget lesions and no new lesions. Documentation by two disease assessments at least 4 weeks apart is required. In the case where the ONLY target lesion is a solitary pelvic mass measured by physical exam, which is not radiographically measurable, a 50% decrease in the LD is required.
- Progression-free Survival (PFS) Using Kaplan-Meier Methods [ Time Frame: From the first teratment of Vosaroxin to the end of Cycle 6 or 28 days after the last treatment at the end of safety follow up period if continued in the extended treatment period ]
PFS is the the time between the date the patient first received Vosaroxin and the earliest date of disease progression.
For patients who experienced disease progression, the date of disease progression will be the earliest date on which disease progression is indicated based on the rules.
For patients who died with no indication of disease progression, the date of death will be the earliest date on which death is documented based on the rules.
For patients who have no indication of disease progression or death, the censoring date will be the Date of Confirmed Contact from the last Survival Follow-Up CRF, or if not in survival follow-up, then the Assessment Date from the last GOG-RECIST CRF, or if no response assessment available, Date of Last Visit / Contact from Extended Treatment Completion CRF if in extended treatment, or from Cycle 6 Completion / Early Termination CRF if not in extended treatment.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00408603
|Study Director:||Sunesis Medical Monitor, MD||Sunesis Pharmaceuticals|