Safety and Efficacy Clinical Study of SNS-595 in Patients With Platinum-Resistant Ovarian Cancer
This study has been completed.
Sponsor:
Sunesis Pharmaceuticals
Information provided by (Responsible Party):
Sunesis Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00408603
First received: December 5, 2006
Last updated: June 5, 2012
Last verified: November 2009
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Epithelial Ovarian Cancer |
Drug: Voreloxin Injection |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase 2 Open-Label, Multicenter Study of SNS-595 Injection in Patients With Platinum-Resistant Ovarian Cancer |
Resource links provided by NLM:
Further study details as provided by Sunesis Pharmaceuticals:
Primary Outcome Measures:
- Objective Response rate [ Time Frame: Prior to Cycles 3, 5, 7, etc... ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Safety [ Time Frame: Each cycle ] [ Designated as safety issue: Yes ]
- Progression-free survival [ Time Frame: For all patients with stable disease or better every 3 months after end of study ] [ Designated as safety issue: No ]
- Evaluation of potential biomarkers [ Time Frame: Each cycle ] [ Designated as safety issue: No ]
| Enrollment: | 143 |
| Study Start Date: | November 2006 |
| Study Completion Date: | October 2010 |
| Primary Completion Date: | October 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: All study patients
All patients will receive voreloxin injection
|
Drug: Voreloxin Injection
All patients will receive voreloxin injection.
Other Name: SNS-595
|
Detailed Description:
Other objectives of this study are to evaluate Progression-free survival and measure CA-125 response rate.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00408603
Locations
| United States, Arizona | |
| Premiere Oncology of Arizona | |
| Scottsdale, Arizona, United States, 85260 | |
| United States, California | |
| Gynecologic Oncology Associates | |
| Newport Beach, California, United States, 92663 | |
| Sharp Clinical Oncology Research | |
| San Diego, California, United States, 92123 | |
| Stanford University | |
| Stanford, California, United States, 94305 | |
| United States, District of Columbia | |
| Medstar Research Institute at Washington Hospital Center | |
| Washington, District of Columbia, United States, 10010 | |
| United States, Illinois | |
| Oncology Specialists, S.C. at Luthern General Advanced Care Center | |
| Park Ridge, Illinois, United States, 60068 | |
| United States, Kentucky | |
| Louisville Oncology Clinical Research Program | |
| Louisville, Kentucky, United States, 40202 | |
| United States, Maryland | |
| The Harry and Jeanette Weinberg Institute at Franklin Square | |
| Baltimore, Maryland, United States, 21237 | |
| United States, Massachusetts | |
| Dana-Farber Cancer Institute | |
| Boston, Massachusetts, United States, 02115 | |
| Massachusetts General Hospital | |
| Boston, Massachusetts, United States, 02114 | |
| United States, New York | |
| Memorial Sloan Kettering Cancer Center (MSKCC) | |
| New York, New York, United States, 10021 | |
| United States, Oregon | |
| Kaiser Permanente NW Region | |
| Portland, Oregon, United States, 97227 | |
| United States, Pennsylvania | |
| University of Pittsburgh Medical Center at Magee-Womens Hospital | |
| Pittsburgh, Pennsylvania, United States, 15213 | |
| United States, Tennessee | |
| Hall and Martin, MD's, P.C. | |
| Knoxville, Tennessee, United States, 37920 | |
| Canada, Alberta | |
| Tom Baker Cancer Centre | |
| Calgary, Alberta, Canada, T2N 4N2 | |
| Canada, British Columbia | |
| BC Cancer Agency at Centre for Southern Interior | |
| Kelowna, British Columbia, Canada, V1Y 5L3 | |
| BC Cancer Agency at Fraser Valley Centre | |
| Surrey, British Columbia, Canada, V3V 1Z2 | |
| BC Cancer Agency at Vancouver | |
| Vancouver, British Columbia, Canada, V5Z 4E6 | |
| BC Cancer Agency - Vancouver Island Centre | |
| Victoria, British Columbia, Canada, V8R 6V5 | |
| Canada, Ontario | |
| Juravinski Cancer Centre Department of Oncology | |
| Hamilton, Ontario, Canada, L8V 5C2 | |
Sponsors and Collaborators
Sunesis Pharmaceuticals
Investigators
| Study Director: | Sunesis Medical Monitor, MD | Sunesis Pharmaceuticals |
More Information
No publications provided
| Responsible Party: | Sunesis Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00408603 History of Changes |
| Other Study ID Numbers: | SPO-0010 |
| Study First Received: | December 5, 2006 |
| Last Updated: | June 5, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Sunesis Pharmaceuticals:
|
second line treatment platinum resistant ovary ovaries |
cancer epithelial carcinomas tumor |
Additional relevant MeSH terms:
|
Ovarian Neoplasms Neoplasms, Glandular and Epithelial Endocrine Gland Neoplasms Neoplasms by Site Neoplasms Ovarian Diseases Genital Neoplasms, Female |
Urogenital Neoplasms Neoplasms by Histologic Type Adnexal Diseases Genital Diseases, Female Endocrine System Diseases Gonadal Disorders |
ClinicalTrials.gov processed this record on May 19, 2013