Neoplasms

All Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Rare Diseases

Carcinoma

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Endocrine Gland Neoplasms

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Genital Neoplasms, Female

Urogenital Neoplasms

Endocrine System Diseases

Gonadal Disorders

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Ovarian Cancer

Ovarian Epithelial Cancer

All patients will receive 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.

Voreloxin Injection

Sunesis Medical Monitor, MD

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.

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

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

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

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

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.

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.

Sunesis Pharmaceuticals

48 mg/m2

60 mg/m2

75 mg/m2

Total

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Asian

Black or African

White or Caucasian

Other, Philippines

Race/Ethnicity, Customized

Height (cm)

Weight (kg)

BSA (m2)

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

Dr. Linda Neuman, Vice President, Clinical Development

Safety Population which included all patients who received any amount of vosaroxin

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

Safety population which included all patients who received any amount of vosaroxin

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

All Stage 1 patients will receive voreloxin injection

Voreloxin Injection: All Stage 1 patients in initial dose level receive voreloxin injection at 48 mg/m2 administered once every 21 days up to 6 cycles.

Stage 48 mg/m2

Following safety of 48 mg/m2 group, next Stagel is 60mg/m2 at 28 day periods up to 6 cycles.

Stage 60 mg/m2

Following safety of 60 mg/m2 group, next Stage is 75 mg/m2 at 28 day periods up to 6 cycles.

Stage 75 mg/m2

Overall Study

Spots Global Cancer Trial Database for Safety and Efficacy Clinical Study of SNS-595 in Patients With Platinum-Resistant Ovarian Cancer

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

Useful links and downloads for this trial