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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00382811 | OVATURE (OVArian TUmor REsponse) A Phase III Study of Weekly Carboplatin With and Without Phenoxodiol in Patients With Platinum-Resistant, Recurrent Epithelial Ovarian Cancer | PHASE3 | COMPLETED | 142 | — | — | Oct 1, 2006 | Apr 1, 2011 | Jul 18, 2016 | 70 | United States, Australia +5 |
| NCT00091377 | Phenoxodiol Combined With Either Cisplatin or Paclitaxel in Patients With Recurrent Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cancer | PHASE1 | COMPLETED | 65 | — | — | Aug 1, 2004 | Mar 1, 2008 | Jul 14, 2016 | 2 | United States, Australia |
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | Daily Phenoxodiol + weekly carboplatin |
| 2 | ACTIVE_COMPARATOR | Daily phenoxodiol placebo + weekly carboplatin |
| Arm A | EXPERIMENTAL | Phenoxodiol IV 3 mg/kg combined with cisplatin 40 mg/m2 on Day 2 6 week cycles |
| Arm B | EXPERIMENTAL | Phenoxodiol IV 3 mg/kg combined with paclitaxel 80 mg/m2 on Day 2 6 week cycles |
| Name | Type | Description |
|---|---|---|
| phenoxodiol | DRUG | 400mg phenoxodiol three times daily in 28 day cycles. |
| carboplatin | DRUG | AUC=2 weekly in 28 day cycles |
| placebo | DRUG | every 8 hours daily in 28 day cycles |
| cisplatin | DRUG | IV 40 mg/m2 on Day 2 Number of Cycles: until progression or unacceptable toxicity or other withdrawal criteria are met. |
| paclitaxel | DRUG | IV 80 mg/m2 on Day 2 Number of Cycles: until progression or unacceptable toxicity or other withdrawal criteria are met. |
Inclusion Criteria: * Histologically-confirmed ovarian, fallopian, or primary peritoneal carcinoma of epithelial origin * Recurrent or persistent advanced disease * Have measurable disease * Undergone at least two courses of therapy with a platinum drug (cisplatin or carboplatin) and have responded...