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

June 28, 2017 updated by: Sunesis Pharmaceuticals

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

183

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 4N2
        • Tom Baker Cancer Centre
    • British Columbia
      • Kelowna, British Columbia, Canada, V1Y 5L3
        • BC Cancer Agency at Centre for Southern Interior
      • Surrey, British Columbia, Canada, V3V 1Z2
        • BC Cancer Agency at Fraser Valley Centre
      • Vancouver, British Columbia, Canada, V5Z 4E6
        • BC Cancer Agency at Vancouver
      • Victoria, British Columbia, Canada, V8R 6V5
        • BC Cancer Agency - Vancouver Island Centre
    • Ontario
      • Hamilton, Ontario, Canada, L8V 5C2
        • Juravinski Cancer Centre Department of Oncology
  • United States
    • Arizona
      • Scottsdale, Arizona, United States, 85260
        • Premiere Oncology of Arizona
    • California
      • Newport Beach, California, United States, 92663
        • Gynecologic Oncology Associates
      • San Diego, California, United States, 92123
        • Sharp Clinical Oncology Research
      • Stanford, California, United States, 94305
        • Stanford University
    • District of Columbia
      • Washington, D.C., District of Columbia, United States, 10010
        • Medstar Research Institute at Washington Hospital Center
    • Illinois
      • Park Ridge, Illinois, United States, 60068
        • Oncology Specialists, S.C. at Luthern General Advanced Care Center
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • Louisville Oncology Clinical Research Program
    • Maryland
      • Baltimore, Maryland, United States, 21237
        • The Harry and Jeanette Weinberg Institute at Franklin Square
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Dana-Farber Cancer Institute
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital
    • New York
      • New York, New York, United States, 10021
        • Memorial Sloan Kettering Cancer Center (MSKCC)
    • Oregon
      • Portland, Oregon, United States, 97227
        • Kaiser Permanente NW Region
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • University of Pittsburgh Medical Center at Magee-Womens Hospital
    • Tennessee
      • Knoxville, Tennessee, United States, 37920
        • Hall and Martin, MD's, P.C.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • SNS-595, vosaroxin, Qinprezo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sunesis Pharmaceuticals

Investigators

  • Study Director: Sunesis Medical Monitor, MD, Sunesis Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 20, 2006

Primary Completion (Actual)

June 9, 2010

Study Completion (Actual)

June 9, 2010

Study Registration Dates

First Submitted

December 5, 2006

First Submitted That Met QC Criteria

December 5, 2006

First Posted (Estimate)

December 7, 2006

Study Record Updates

Last Update Posted (Actual)

July 27, 2017

Last Update Submitted That Met QC Criteria

June 28, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SPO-0010

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified data of individual participants experiencing Serious Adverse Events, post trial completion

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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