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

NCT00408603 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: SPO-0010
• Study Type: interventional
• Target: 183
• Locations: 2 countries
• Sites: 20

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.

Conditions

Epithelial Ovarian Cancer

Keywords

second line treatment; platinum resistant; ovary; ovaries; cancer; epithelial; carcinomas; tumor

Outcome Measures

Primary Outcomes (1)

• 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.

  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 Outcomes (1)

• Progression-free Survival (PFS) Using Kaplan-Meier Methods

  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

Study Arms (1)

All study patients

EXPERIMENTAL

All patients will receive voreloxin injection

Drug: Voreloxin Injection

Interventions

Voreloxin Injection DRUG

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.

Also known as: SNS-595, vosaroxin, Qinprezo

All study patients

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sunesis Pharmaceuticals: lead

Study Sites (20)

Premiere Oncology of Arizona

Scottsdale, Arizona, 85260, United States

Location

Gynecologic Oncology Associates

Newport Beach, California, 92663, United States

Location

Sharp Clinical Oncology Research

San Diego, California, 92123, United States

Location

Stanford University

Stanford, California, 94305, United States

Location

Medstar Research Institute at Washington Hospital Center

Washington D.C., District of Columbia, 10010, United States

Location

Oncology Specialists, S.C. at Luthern General Advanced Care Center

Park Ridge, Illinois, 60068, United States

Location

Louisville Oncology Clinical Research Program

Louisville, Kentucky, 40202, United States

Location

The Harry and Jeanette Weinberg Institute at Franklin Square

Baltimore, Maryland, 21237, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

Memorial Sloan Kettering Cancer Center (MSKCC)

New York, New York, 10021, United States

Location

Kaiser Permanente NW Region

Portland, Oregon, 97227, United States

Location

University of Pittsburgh Medical Center at Magee-Womens Hospital

Pittsburgh, Pennsylvania, 15213, United States

Location

Hall and Martin, MD's, P.C.

Knoxville, Tennessee, 37920, United States

Location

Tom Baker Cancer Centre

Calgary, Alberta, T2N 4N2, Canada

Location

BC Cancer Agency at Centre for Southern Interior

Kelowna, British Columbia, V1Y 5L3, Canada

Location

BC Cancer Agency at Fraser Valley Centre

Surrey, British Columbia, V3V 1Z2, Canada

Location

BC Cancer Agency at Vancouver

Vancouver, British Columbia, V5Z 4E6, Canada

Location

BC Cancer Agency - Vancouver Island Centre

Victoria, British Columbia, V8R 6V5, Canada

Location

Juravinski Cancer Centre Department of Oncology

Hamilton, Ontario, L8V 5C2, Canada

Location

MeSH Terms

Conditions

Carcinoma, Ovarian Epithelial; Neoplasms; Carcinoma

Interventions

vosaroxin

Condition Hierarchy (Ancestors)

Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Ovarian Neoplasms; Endocrine Gland Neoplasms; Neoplasms by Site; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Limitations and Caveats

No statistical testings were performed to compare any of the treatment groups. No p-values or odds ratios were reported.

Results Point of Contact

• Title: Dr. Linda Neuman, Vice President, Clinical Development
• Organization: Sunesis Pharmaceuticals, Inc.

lneuman@sunesis.com

(650) 266-3760

Study Officials

• Sunesis Medical Monitor, MD

  Sunesis Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 5, 2006
• First Posted: December 7, 2006
• Study Start: December 20, 2006
• Primary Completion: June 9, 2010
• Study Completion: June 9, 2010
• Last Updated: July 27, 2017
• Results First Posted: June 28, 2017

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will share

Locations

CA (6); US (14)