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

• Status: Completed
• Trial end date: 2010-06-09
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sunesis Pharmaceuticals

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.