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

Primary Purpose

Epithelial Ovarian Cancer

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Voreloxin Injection
Sponsored by
Sunesis Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Epithelial Ovarian Cancer focused on measuring second line treatment, platinum resistant, ovary, ovaries, cancer, epithelial, carcinomas, tumor

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Premiere Oncology of Arizona
  • Gynecologic Oncology Associates
  • Sharp Clinical Oncology Research
  • Stanford University
  • Medstar Research Institute at Washington Hospital Center
  • Oncology Specialists, S.C. at Luthern General Advanced Care Center
  • Louisville Oncology Clinical Research Program
  • The Harry and Jeanette Weinberg Institute at Franklin Square
  • Massachusetts General Hospital
  • Dana-Farber Cancer Institute
  • Memorial Sloan Kettering Cancer Center (MSKCC)
  • Kaiser Permanente NW Region
  • University of Pittsburgh Medical Center at Magee-Womens Hospital
  • Hall and Martin, MD's, P.C.
  • Tom Baker Cancer Centre
  • BC Cancer Agency at Centre for Southern Interior
  • BC Cancer Agency at Fraser Valley Centre
  • BC Cancer Agency at Vancouver
  • BC Cancer Agency - Vancouver Island Centre
  • Juravinski Cancer Centre Department of Oncology

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

All study patients

Arm Description

All patients will receive voreloxin injection

Outcomes

Primary Outcome Measures

Overall Response Rate (CR+PR) Per Investigator Assessment Based on GOG-RECIST Criteria
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
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.

Full Information

First Posted
December 5, 2006
Last Updated
June 28, 2017
Sponsor
Sunesis Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00408603
Brief Title
Safety and Efficacy Clinical Study of SNS-595 in Patients With Platinum-Resistant Ovarian Cancer
Official Title
A Phase 2 Open-Label, Multicenter Study of SNS-595 Injection in Patients With Platinum-Resistant Ovarian Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
June 2017
Overall Recruitment Status
Completed
Study Start Date
December 20, 2006 (Actual)
Primary Completion Date
June 9, 2010 (Actual)
Study Completion Date
June 9, 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sunesis Pharmaceuticals

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epithelial Ovarian Cancer
Keywords
second line treatment, platinum resistant, ovary, ovaries, cancer, epithelial, carcinomas, tumor

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
183 (Actual)

8. Arms, Groups, and Interventions

Arm Title
All study patients
Arm Type
Experimental
Arm Description
All patients will receive voreloxin injection
Intervention Type
Drug
Intervention Name(s)
Voreloxin Injection
Other Intervention Name(s)
SNS-595, vosaroxin, Qinprezo
Intervention Description
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.
Primary Outcome Measure Information:
Title
Overall Response Rate (CR+PR) Per Investigator Assessment Based on GOG-RECIST Criteria
Description
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.
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
Secondary Outcome Measure Information:
Title
Progression-free Survival (PFS) Using Kaplan-Meier Methods
Description
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.
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

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sunesis Medical Monitor, MD
Organizational Affiliation
Sunesis Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Premiere Oncology of Arizona
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85260
Country
United States
Facility Name
Gynecologic Oncology Associates
City
Newport Beach
State/Province
California
ZIP/Postal Code
92663
Country
United States
Facility Name
Sharp Clinical Oncology Research
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Stanford University
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Name
Medstar Research Institute at Washington Hospital Center
City
Washington, D.C.
State/Province
District of Columbia
ZIP/Postal Code
10010
Country
United States
Facility Name
Oncology Specialists, S.C. at Luthern General Advanced Care Center
City
Park Ridge
State/Province
Illinois
ZIP/Postal Code
60068
Country
United States
Facility Name
Louisville Oncology Clinical Research Program
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
The Harry and Jeanette Weinberg Institute at Franklin Square
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21237
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Dana-Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Memorial Sloan Kettering Cancer Center (MSKCC)
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Kaiser Permanente NW Region
City
Portland
State/Province
Oregon
ZIP/Postal Code
97227
Country
United States
Facility Name
University of Pittsburgh Medical Center at Magee-Womens Hospital
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
Hall and Martin, MD's, P.C.
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37920
Country
United States
Facility Name
Tom Baker Cancer Centre
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4N2
Country
Canada
Facility Name
BC Cancer Agency at Centre for Southern Interior
City
Kelowna
State/Province
British Columbia
ZIP/Postal Code
V1Y 5L3
Country
Canada
Facility Name
BC Cancer Agency at Fraser Valley Centre
City
Surrey
State/Province
British Columbia
ZIP/Postal Code
V3V 1Z2
Country
Canada
Facility Name
BC Cancer Agency at Vancouver
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 4E6
Country
Canada
Facility Name
BC Cancer Agency - Vancouver Island Centre
City
Victoria
State/Province
British Columbia
ZIP/Postal Code
V8R 6V5
Country
Canada
Facility Name
Juravinski Cancer Centre Department of Oncology
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8V 5C2
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
De-identified data of individual participants experiencing Serious Adverse Events, post trial completion

Learn more about this trial

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

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