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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 28, 2017
Last verified: June 2017
  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: Intervention Model: Single Group Assignment
Masking: No masking
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:
  • Overall Response Rate (CR+PR) Per Investigator Assessment Based on GOG-RECIST Criteria [ Time Frame: GOG-RECIST assessment obtained on cycle2, 4 and 6 Day 21for patients treated with 48 mg/m2 SNS-595 and Day 28 for patients treated with 60 mg/m2, through 28 (±14) days afte the last treatment at the end of safety follow up period ]
    Response rate was calculated per investigator's tumor assessment based on GOG-RECIST, which includes radiographic imaging, physical examination results, and CA-125 levels. No independent review of CT scans (lesion assessments) was performed. CR: disappearance of all target and nontarget lesions and no evidence of new lesions documented by two disease assessments at least 4 weeks apart. Normalization of CA125, if elevated at baseline, is required for ovarian carcinoma studies. PR is >= 30% decrease in the sum of LD of all target measurable lesions taking as reference the baseline sum of LD. There can be no unequivocal progression of nontarget lesions and no new lesions. Documentation by two disease assessments at least 4 weeks apart is required. In the case where the ONLY target lesion is a solitary pelvic mass measured by physical exam, which is not radiographically measurable, a 50% decrease in the LD is required.


Secondary Outcome Measures:
  • Progression-free Survival (PFS) Using Kaplan-Meier Methods [ Time Frame: From the first teratment of Vosaroxin to the end of Cycle 6 or 28 days after the last treatment at the end of safety follow up period if continued in the extended treatment period ]

    PFS is the the time between the date the patient first received Vosaroxin and the earliest date of disease progression.

    For patients who experienced disease progression, the date of disease progression will be the earliest date on which disease progression is indicated based on the rules.

    For patients who died with no indication of disease progression, the date of death will be the earliest date on which death is documented based on the rules.

    For patients who have no indication of disease progression or death, the censoring date will be the Date of Confirmed Contact from the last Survival Follow-Up CRF, or if not in survival follow-up, then the Assessment Date from the last GOG-RECIST CRF, or if no response assessment available, Date of Last Visit / Contact from Extended Treatment Completion CRF if in extended treatment, or from Cycle 6 Completion / Early Termination CRF if not in extended treatment.



Enrollment: 183
Actual Study Start Date: December 20, 2006
Study Completion Date: June 9, 2010
Primary Completion Date: June 9, 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 in initial dose level receive voreloxin injection at 48 mg/m2 administered once every 21 days up to 6 cycles. Subsequent levels are of 60 mg/m2 or 75 mg/m2 every 28 days up to 6 cycles if safety acceptable.
Other Name: SNS-595, vosaroxin, Qinprezo

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   (Adult, Senior)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   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, D.C., 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
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
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

Responsible Party: Sunesis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00408603     History of Changes
Other Study ID Numbers: SPO-0010
Study First Received: December 5, 2006
Results First Received: April 7, 2017
Last Updated: June 28, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified data of individual participants experiencing Serious Adverse Events, post trial completion

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

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 27, 2017