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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01020006 | Study of Safety and Tolerability of PCI-27483 in Patients With Pancreatic Cancer Patients Receiving Treatment With Gemcitabine | PHASE2 | COMPLETED | 42 | — | — | Nov 1, 2009 | - | Apr 24, 2014 | 17 | United States |
Clinically meaningful toxicity adverse events will be defined in accordance with by CTCAE v3.0
| Arm | Type | Description |
|---|---|---|
| Gemcitabine | ACTIVE_COMPARATOR | Subjects receive Gemcitabine 1000 mg/m2 weekly intravenous infusion. |
| PCI-27483 + Gemcitabine | EXPERIMENTAL | Part A: Subjects received PCI-27483 0.8 mg/kg BID as initial dose and may be escalated to 1.2, and 1.5 mg/kg BID. At the same time, subjects received Gemcitabine 1000 mg/m2 weekly intravenous infusion. Part B: Subjects received the PCI-27483 at 1.2 mg/kg BID and Gemcitabine 1000 mg/m2 weekly intravenous infusion. |
| Name | Type | Description |
|---|---|---|
| PCI-27483 | DRUG | Part A: Closed to enrollment.Part B: Approximately 20 patients will be randomized to the control arm that will receive a standard regimen of gemcitabine and 20 patients will be randomized to the PCI-27483 arm and treated with both gemcitabine and PCI-27483. PCI-27483 will be administered as subcutaneous (SC) injections, nominally at a dosage of 1.2 mg/kg BID. Patients receiving PCI-27483 with a tumor response or stable disease at 12 weeks will have the option to continue PCI-27483 treatment until disease progression or the investigator considers the study treatment no longer tolerable. Treatment with gemcitabine may continue per standard of care. All evaluable patients will roll over into Part C at week 16 (Day 113±5). If 2 consecutive INRs at 2 hours postdose are \>3.50,a reduced dosage will be calculated. |
| Gemcitabine | DRUG | - |
Inclusion Criteria: 1. Men or women at least 18 years old 2. Body weight ≥ 40 and ≤ 100 kg. 3. Part A: Metastatic ductal adenocarcinoma of the pancreas diagnosed ≤ 4 months prior to enrollment. (Locally advanced does not have any criteria) 4. Part B: Locally advanced ductal adenocarcinoma of the pa...