Safety and Efficacy Clinical Study of SNS-595 in Patients With Platinum-Resistant Ovarian Cancer
NCT ID: NCT00408603
Last Updated: 2017-07-27
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
183 participants
INTERVENTIONAL
2006-12-20
2010-06-09
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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All study patients
All patients will receive voreloxin injection
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.
Interventions
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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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Completed at least one Platinum Based Therapy (PBT) regimen (carboplatin, cisplatin, or another organoplatinum compound).
* Evidence of platinum-resistant disease, relapse/progression within 6 months of the completion of PBT, or intolerant to PBT (inability to receive PBT due to hypersensitivity reactions to platinum)
* Patients with primary platinum-resistant disease are allowed to receive no more than one nonplatinum cytotoxic regimen and no more than one noncytotoxic regimen for the management of recurrent or persistent disease after the development of primary platinum-resistance.
* Measurable disease per GOG-RECIST criteria
* GOG Performance Status of 0 or 1
Exclusion Criteria
* Monoclonal antibody therapy within 4 weeks prior to clinical study entry
* Unresolved or impending bowel obstruction
* Other active malignancies or other malignancies within the last 12 months except nonmelanoma skin cancer or cervical intraepithelial neoplasia
* Prior radiotherapy to more than 25% of the marrow space
* Requiring hemodialysis or peritoneal dialysis
* Myocardial infarction or cerebrovascular accident/transient ischemic attack within the 6 months prior to the anticipated first day of treatment
* Thromboembolic event (deep vein thrombosis \[DVT\] or pulmonary embolus \[PE\]) within 28 days prior to the anticipated first day of treatment
* History of active CNS metastases
* Any other medical, psychological, or social condition that would contraindicate the patient's participation in the clinical study due to safety or compliance with clinical study procedures.
18 Years
FEMALE
No
Sponsors
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Sunesis Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Sunesis Medical Monitor, MD
Role: STUDY_DIRECTOR
Sunesis Pharmaceuticals
Locations
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Premiere Oncology of Arizona
Scottsdale, Arizona, United States
Gynecologic Oncology Associates
Newport Beach, California, United States
Sharp Clinical Oncology Research
San Diego, California, United States
Stanford University
Stanford, California, United States
Medstar Research Institute at Washington Hospital Center
Washington D.C., District of Columbia, United States
Oncology Specialists, S.C. at Luthern General Advanced Care Center
Park Ridge, Illinois, United States
Louisville Oncology Clinical Research Program
Louisville, Kentucky, United States
The Harry and Jeanette Weinberg Institute at Franklin Square
Baltimore, Maryland, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Memorial Sloan Kettering Cancer Center (MSKCC)
New York, New York, United States
Kaiser Permanente NW Region
Portland, Oregon, United States
University of Pittsburgh Medical Center at Magee-Womens Hospital
Pittsburgh, Pennsylvania, United States
Hall and Martin, MD's, P.C.
Knoxville, Tennessee, United States
Tom Baker Cancer Centre
Calgary, Alberta, Canada
BC Cancer Agency at Centre for Southern Interior
Kelowna, British Columbia, Canada
BC Cancer Agency at Fraser Valley Centre
Surrey, British Columbia, Canada
BC Cancer Agency at Vancouver
Vancouver, British Columbia, Canada
BC Cancer Agency - Vancouver Island Centre
Victoria, British Columbia, Canada
Juravinski Cancer Centre Department of Oncology
Hamilton, Ontario, Canada
Countries
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Other Identifiers
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SPO-0010
Identifier Type: -
Identifier Source: org_study_id
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