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

Epithelial Ovarian Cancer Clinical Trial

Official title:

A Phase 2 Open-Label, Multicenter Study of SNS-595 Injection in Patients With Platinum-Resistant Ovarian Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00408603
• Other study ID #: SPO-0010
• Status: Completed
• Phase: Phase 2
• First received: December 5, 2006
• Last updated: June 5, 2012
• Start date: November 2006
• Est. completion date: October 2010

Study information

• Verified date: November 2009
• Source: Sunesis Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 143
• Est. completion date: October 2010
• Est. primary completion date: October 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Epithelial Ovarian Cancer
• Neoplasms, Glandular and Epithelial
• Ovarian Neoplasms

Intervention

Drug:
• Voreloxin Injection
All patients will receive voreloxin injection.

Locations

Country	Name	City	State
Canada	Tom Baker Cancer Centre	Calgary	Alberta
Canada	Juravinski Cancer Centre Department of Oncology	Hamilton	Ontario
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
United States	The Harry and Jeanette Weinberg Institute at Franklin Square	Baltimore	Maryland
United States	Dana-Farber Cancer Institute	Boston	Massachusetts
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Hall and Martin, MD's, P.C.	Knoxville	Tennessee
United States	Louisville Oncology Clinical Research Program	Louisville	Kentucky
United States	Memorial Sloan Kettering Cancer Center (MSKCC)	New York	New York
United States	Gynecologic Oncology Associates	Newport Beach	California
United States	Oncology Specialists, S.C. at Luthern General Advanced Care Center	Park Ridge	Illinois
United States	University of Pittsburgh Medical Center at Magee-Womens Hospital	Pittsburgh	Pennsylvania
United States	Kaiser Permanente NW Region	Portland	Oregon
United States	Sharp Clinical Oncology Research	San Diego	California
United States	Premiere Oncology of Arizona	Scottsdale	Arizona
United States	Stanford University	Stanford	California
United States	Medstar Research Institute at Washington Hospital Center	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Sunesis Pharmaceuticals

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective Response rate		Prior to Cycles 3, 5, 7, etc...	No
Secondary	Safety		Each cycle	Yes
Secondary	Progression-free survival		For all patients with stable disease or better every 3 months after end of study	No
Secondary	Evaluation of potential biomarkers		Each cycle	No