Ovarian Cancer Clinical Trial

Safety and Efficacy Clinical Study of SNS-595 in Patients With Platinum-Resistant Ovarian Cancer

Summary

The purpose of this study is to evaluate the objective response rate, safety and identify potential biomarkers in platinum-resistant ovarian cancer patients treated with voreloxin injection given on a 28-day cycle.

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Full Description

Other objectives of this study are to evaluate Progression-free survival and measure CA-125 response rate.

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Eligibility Criteria

Inclusion Criteria:

Histologically or cytologically documented epithelial ovarian cancer, primary peritoneal carcinoma, or fallopian tube cancer
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:

Radiotherapy, chemotherapy, and hormonal, cytokine, or targeted therapy, within 3 weeks (nitrosurea or mitomycin C within 6 weeks) prior to the anticipated first day of treatment.
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.

Please note: There are additional inclusion/exclusion criteria for this study. Please contact the study center for additional information and to determine if you meet all study criteria.

Study is for people with:

Ovarian Cancer

Phase:

Phase 2

Estimated Enrollment:

183

Study ID:

NCT00408603

Recruitment Status:

Completed

Sponsor:

Sunesis Pharmaceuticals

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There are 20 Locations for this study

See Locations Near You

Premiere Oncology of Arizona
Scottsdale Arizona, 85260, United States
Gynecologic Oncology Associates
Newport Beach California, 92663, United States
Sharp Clinical Oncology Research
San Diego California, 92123, United States
Stanford University
Stanford California, 94305, United States
Medstar Research Institute at Washington Hospital Center
Washington, D.C. District of Columbia, 10010, United States
Oncology Specialists, S.C. at Luthern General Advanced Care Center
Park Ridge Illinois, 60068, United States
Louisville Oncology Clinical Research Program
Louisville Kentucky, 40202, United States
The Harry and Jeanette Weinberg Institute at Franklin Square
Baltimore Maryland, 21237, United States
Massachusetts General Hospital
Boston Massachusetts, 02114, United States
Dana-Farber Cancer Institute
Boston Massachusetts, 02115, United States
Memorial Sloan Kettering Cancer Center (MSKCC)
New York New York, 10021, United States
Kaiser Permanente NW Region
Portland Oregon, 97227, United States
University of Pittsburgh Medical Center at Magee-Womens Hospital
Pittsburgh Pennsylvania, 15213, United States
Hall and Martin, MD's, P.C.
Knoxville Tennessee, 37920, United States
Tom Baker Cancer Centre
Calgary Alberta, T2N 4, Canada
BC Cancer Agency at Centre for Southern Interior
Kelowna British Columbia, V1Y 5, Canada
BC Cancer Agency at Fraser Valley Centre
Surrey British Columbia, V3V 1, Canada
BC Cancer Agency at Vancouver
Vancouver British Columbia, V5Z 4, Canada
BC Cancer Agency - Vancouver Island Centre
Victoria British Columbia, V8R 6, Canada
Juravinski Cancer Centre Department of Oncology
Hamilton Ontario, L8V 5, Canada

How clear is this clinincal trial information?

Study is for people with:

Ovarian Cancer

Phase:

Phase 2

Estimated Enrollment:

183

Study ID:

NCT00408603

Recruitment Status:

Completed

Sponsor:


Sunesis Pharmaceuticals

How clear is this clinincal trial information?

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