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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01360853 | Gemcitabine and ON 01910.Na in Previously Untreated Metastatic Pancreatic Cancer | PHASE3 | COMPLETED | 160 | — | — | May 1, 2011 | Dec 1, 2015 | Aug 4, 2016 | 46 | United States, Hungary +3 |
This study's primary outcome is overall survival, defined as the time from randomization to death from any cause. All patients will be followed until death. Patients lost to follow-up will be censored at the time last known alive.
| Arm | Type | Description |
|---|---|---|
| Arm A: Combination | EXPERIMENTAL | Arm A: Gemcitabine, 1000 mg/m2 weekly for 3 weeks of a 4 week cycle, + ON 01910.Na, 1800 mg/m2 via 2 hr CIV infusions administered twice weekly for 3 weeks of a 4 week cycle. |
| Arm B: Gemcitabine only | ACTIVE_COMPARATOR | Arm B: Gemcitabine only, 1000 mg/m2 weekly for 3 weeks of a 4 week cycle. |
| Name | Type | Description |
|---|---|---|
| ON 01910.Na | DRUG | ON 01910.Na, 1800 mg/m2 via 2 hr CIV infusions administered twice weekly for 3 weeks of a 4 week cycle. |
| Gemcitabine | DRUG | Gemcitabine 1000 mg/m2 weekly for 3 weeks of a 4 week cycle. |
Inclusion Criteria: * Patients at least 18 years old presenting with histopathologically or cytologically confirmed metastatic adenocarcinoma of the pancreas; metastatic disease is defined as disease which has spread beyond the peri-pancreatic lymph nodes. * Patients must have received no prior che...