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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01097018 | Perifosine Plus Capecitabine Versus Placebo Plus Capecitabine in Patients With Refractory Advanced Colorectal Cancer | PHASE3 | COMPLETED | 468 | — | — | Apr 1, 2010 | Apr 1, 2012 | Jul 2, 2013 | 65 | United States |
| Arm | Type | Description |
|---|---|---|
| Perifosine + Capecitabine | ACTIVE_COMPARATOR | Perifosine 1 tablet daily + Capecitabine BID days 1 - 14 every 21 days |
| Placebo + Capecitabine | PLACEBO_COMPARATOR | Placebo 1 tablet daily + Capecitabine BID days 1 - 14 every 21 days |
| Name | Type | Description |
|---|---|---|
| Capecitabine | DRUG | 1000 mg/m2 BID/ Days 1-14 |
| Perifosine | DRUG | 50 mg daily x 21 days |
| Placebo | DRUG | 1 pill daily x 21 days |
Inclusion Criteria: * Patients must have failed available therapy for the treatment of advanced colorectal cancer, including fluoropyrimidine, irinotecan, oxaliplatin, bevacizumab and for K-ras wild-type (WT) patients, anti-EGFR antibody (cetuximab or panitumumab) containing therapies. * For oxalip...