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Also known as Voreloxin Injection, Voreloxin
Voreloxin and cytarabine · 2 trials · 2 indications
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.
Patients were treated in cohorts with escalating doses of vosaroxin administered in combination with cytarabine in Schedule A, and with vosaroxin in escalating doses in Schedule B. For both Schedules, the highest dose at which fewer than 2 of 6 (\<0.33) patients experienced a dose-limiting toxicity (DLT) during induction became the MTD and the recommended future dose.
| Arm | Type | Description |
|---|---|---|
| All study patients | EXPERIMENTAL | All patients will receive voreloxin injection |
| Voreloxin injection and cytarabine | EXPERIMENTAL | Dose-escalation Phase * Schedule A: * Schedule B: Expansion Phase * Schedule A: * Schedule B: |
| 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. |
| Voreloxin injection and cytarabine | DRUG | Dose-escalation Phase * Schedule A: vosaroxin injection (dose-escalation from 10 to 90 mg/m2) on Days 1 and 4 in combination with cytarabine (24-hour CIV infusion of 400 mg/m2/day × 5 days) * Schedule B: vosaroxin injection (dose-escalation from 70 to 90 mg/m2) on Days 1 and 4 in combination with cytarabine (2-hour intravenous \[IV\] infusion of 1 g/m2/day × 5 days) Expansion Phase The MTD determined in the dose-escalation phase was used in the expansion phase. * Schedule A: 80 mg/m2 vosaroxin on Days 1 and 4 in combination with cytarabine (24-hour CIV infusion at 400 mg/m2/day × 5 days) * Schedule B: 90 mg/m2 vosaroxin (dose-escalation) on Days 1 and 4 in combination with cytarabine (2 hour IV infusion at 1 g/m2/day × 5 days) |
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 and cytarabine is an investigational combination of the small molecule voreloxin with cytarabine, developed by Viracta Therapeutics, Inc. (ticker VIRX). It has been studied in oncology, specifically in acute myeloid leukemia and epithelial ovarian cancer. The combination is not approved and remains in clinical development.
Voreloxin and cytarabine has been studied for the treatment of acute myeloid leukemia, and voreloxin has also been evaluated in epithelial ovarian cancer. The acute myeloid leukemia work combined voreloxin with cytarabine in adults aged 18 years and older. These uses remain investigational.
Viracta Therapeutics, Inc., which trades under the ticker VIRX, is the developer of voreloxin and cytarabine. The company sponsored the clinical studies of the combination in acute myeloid leukemia and of voreloxin in platinum-resistant epithelial ovarian cancer.
Voreloxin and cytarabine is in Phase 1 development. The Phase 1 study evaluated the safety and tolerability of the voreloxin and cytarabine combination in acute myeloid leukemia. Voreloxin has also been tested in a separate Phase 2 study in platinum-resistant epithelial ovarian cancer.
The Phase 1 trial NCT00541866 studied the safety and tolerability of the voreloxin and cytarabine combination in acute myeloid leukemia and enrolled 110 patients in the United States. A separate Phase 2 trial, NCT00408603, studied voreloxin in platinum-resistant ovarian cancer and enrolled 183 patients across the United States and Canada. Both trials are completed.