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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00844649 | Phase III Study of ABI-007(Albumin-bound Paclitaxel) Plus Gemcitabine Versus Gemcitabine in Metastatic Adenocarcinoma of the Pancreas | PHASE3 | COMPLETED | 861 | — | — | Mar 1, 2009 | Apr 9, 2013 | Nov 25, 2019 | 193 | United States, Australia +9 |
| NCT00398086 | Gemcitabine Plus Albumin-bound Paclitaxel In Patients With Advanced Metastatic Pancreatic Cancer | PHASE1 | COMPLETED | 67 | — | — | Nov 1, 2006 | Dec 1, 2010 | Nov 22, 2019 | 5 | United States |
Overall survival was defined as the time from the date of randomization to the date of death from all causes. Participants who did not die were censored at the last known time the participant was alive. Patient survival was summarized using Kaplan-Meier methods.
A dose-limiting toxicity (DLT) is defined as one or more of the following toxicities related to study drug during Cycle 1, according to the National Cancer Institute (NCI) Common Toxicity Criteria for Adverse Events (CTCAE), Version 3: * Grade 4 neutropenia lasting \>3 days in the absence of growth factor support; * Grade 4 neutropenia associated with fever \>38.5°C; * Any other Grade 4 hematological toxicity; * Grade 3 thrombocytopenia with hemorrhage; * Grade 3 or 4 nausea, vomiting or diarrhea despite prophylaxis or treatment with an optimal anti-emetic or anti-diarrhea regimen; * Any other Grade 3 or higher non-hematological toxicity attributable to the study drug, excluding alopecia and fatigue.
| Arm | Type | Description |
|---|---|---|
| Albumin-bound paclitaxel (ABI-007)/Gemcitabine | EXPERIMENTAL | ABI-007 125 mg/m2 administered in combination with gemcitabine 1000 mg/m2 weekly for 3 weeks followed by one week of rest. |
| Gemcitabine | ACTIVE_COMPARATOR | Gemcitabine, 1000 mg/m2 administered weekly for 7 weeks followed by a week of rest (Cycle 1), followed by cycles of weekly administration for 3 weeks followed by a week of rest (Cycle 2 onward). |
| 100 mg/m^2 | EXPERIMENTAL | Participants received albumin-bound paclitaxel 100 mg/m\^2 followed by gemcitabine 1000 mg/m\^2 by intravenous infusion (IV) on Days 1, 8 and 15 of each 28 day cycle (dose level one). Treatment continued until progressive disease or unacceptable toxicity. |
| 125 mg/m^2 | EXPERIMENTAL | Participants received albumin-bound paclitaxel 125 mg/m\^2 followed by gemcitabine 1000 mg/m\^2 by intravenous infusion (IV) on Days 1, 8 and 15 of each 28 day cycle (dose level two). Treatment continued until progressive disease or unacceptable toxicity. |
| 150 mg/m^2 | EXPERIMENTAL | Participants received albumin-bound paclitaxel 150 mg/m\^2 followed by gemcitabine 1000 mg/m\^2 by intravenous infusion (IV) on Days 1, 8 and 15 of each 28 day cycle (dose level three). Treatment continued until progressive disease or unacceptable toxicity. |
| Name | Type | Description |
|---|---|---|
| Albumin-bound paclitaxel (ABI-007) | DRUG | ABI-007 125 mg/m\^2 administered by intravenous infusion |
| Gemcitabine | DRUG | Gemcitabine, 1000 mg/m2 administered weekly for 7 weeks, Day 1 through Day 43 followed by a week of rest (Cycle 1), followed by cycles of weekly administration for 3 weeks, Days 1, 8, and 15 followed by a week of rest (Cycle 2 onward). |
| Albumin-bound paclitaxel | DRUG | Administered by intravenous infusion over 30 minutes. |
Inclusion Criteria A participant will be eligible for inclusion in this study only if all of the following criteria are met: 1. Participant has definitive histologically or cytologically confirmed metastatic adenocarcinoma of the pancreas. The definitive diagnosis of metastatic pancreatic adenocar...