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

Completed · Phase 2

Conditions studied: Epithelial Ovarian Cancer

In brief

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.

Key facts

Study ID

NCT00408603

Run by

Sunesis Pharmaceuticals

People needed

183

Starts

2006-12-20

Expected to finish

2010-06-09

Last updated by the study team

2017-07-27

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• 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

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.