Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00635193 | Efficacy and Safety Study of M200(Volociximab in Combination With Liposomal Doxorubicin) | PHASE1 | COMPLETED | 138 | — | — | Jul 1, 2007 | Oct 1, 2009 | Jan 18, 2013 | 39 | United States, Australia +7 |
| Arm | Type | Description |
|---|---|---|
| Cohort 1 | OTHER | Three subjects will be treated with liposomal doxorubicin, 40 mg/m2 q4wk, and volociximab, 7.5 mg/kg qwk |
| Cohort 2 | OTHER | liposomal doxorubicin, 40 mg/m2 q4wk, and volociximab 15 mg/kg qwk |
| Group A | OTHER | liposomal doxorubicin, 40 mg/m2 q4wk |
| Group B | OTHER | liposomal doxorubicin, 40 mg/m2 q4wk, and volociximab 15 mg/kg q2wk (or other dose and schedule) |
| Group C | OTHER | liposomal doxorubicin, 40 mg/m2 q4wk, and volociximab 15 mg/kg qwk (or other dose and schedule) |
| Name | Type | Description |
|---|---|---|
| M200 (Volociximab) | DRUG | 7.5 mg/kg, IV infusion every week until disease progression |
| Liposomal Doxorubicin | DRUG | 40 mg/m2, IV infustions every 4 weeks until disease progression, the maxium number of doses a subject can receive is 12. |
Inclusion Criteria: * Females aged \>= 18 years old at the time of informed consent. * Advanced (Stage III or IV) histologically documented epithelial ovarian cancer or primary peritoneal cancer (excluding small, round-cell histologies). * Recurrent or persistent disease. * Received no more than 2 ...