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

Phase 2
18 Years
Not Enrolling
Epithelial Ovarian Cancer

Thank you

Trial Information

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

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

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

- 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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Objective Response rate

Outcome Time Frame:

Prior to Cycles 3, 5, 7, etc...

Safety Issue:


Principal Investigator

Sunesis Medical Monitor, MD

Investigator Role:

Study Director

Investigator Affiliation:

Sunesis Pharmaceuticals


United States: Food and Drug Administration

Study ID:




Start Date:

November 2006

Completion Date:

October 2010

Related Keywords:

  • Epithelial Ovarian Cancer
  • second line treatment
  • platinum resistant
  • ovary
  • ovaries
  • cancer
  • epithelial
  • carcinomas
  • tumor
  • Ovarian Neoplasms
  • Neoplasms, Glandular and Epithelial



Stanford UniversityStanford, California  94305
Dana-Farber Cancer InstituteBoston, Massachusetts  02115
Massachusetts General HospitalBoston, Massachusetts  02114-2617
Gynecologic Oncology AssociatesNewport Beach, California  92663
Sharp Clinical Oncology ResearchSan Diego, California  92123
Premiere Oncology of ArizonaScottsdale, Arizona  85260
Medstar Research Institute at Washington Hospital CenterWashington, District of Columbia  10010
Oncology Specialists, S.C. at Luthern General Advanced Care CenterPark Ridge, Illinois  60068
Louisville Oncology Clinical Research ProgramLouisville, Kentucky  40202
The Harry and Jeanette Weinberg Institute at Franklin SquareBaltimore, Maryland  21237
Memorial Sloan Kettering Cancer Center (MSKCC)New York, New York  10021
Kaiser Permanente NW RegionPortland, Oregon  97227
University of Pittsburgh Medical Center at Magee-Womens HospitalPittsburgh, Pennsylvania  15213
Hall and Martin, MD's, P.C.Knoxville, Tennessee  37920