Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Voreloxin · 1 trial · 1 indication
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.
| Arm | Type | Description |
|---|---|---|
| All study patients | EXPERIMENTAL | All patients will receive voreloxin injection |
| Name | Type | Description |
|---|---|---|
| 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. |
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-resis...
Voreloxin is an investigational small molecule being studied for the treatment of epithelial ovarian cancer and acute myeloid leukemia. In clinical trials, it has been evaluated in patients with platinum-resistant ovarian cancer and in combination with cytarabine for acute myeloid leukemia.
Voreloxin is being developed by Viracta Therapeutics, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol VIRX.
Voreloxin is in Phase 2 clinical development for epithelial ovarian cancer. A Phase 1 study has also been completed for acute myeloid leukemia. The drug is investigational and has not been approved by regulatory authorities.
Voreloxin has been studied in two completed clinical trials. NCT00408603 was a Phase 2 study in 183 patients with platinum-resistant epithelial ovarian cancer. NCT00541866 was a Phase 1 study of Voreloxin combined with cytarabine in 110 patients with acute myeloid leukemia.
Yes, Voreloxin was previously known as SNS-595. The Phase 2 clinical trial in ovarian cancer, NCT00408603, was originally titled as a study of SNS-595 in patients with platinum-resistant ovarian cancer.