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

This study has been completed.
Sponsor:
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
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on July 23, 2014