NCT00844649

Phase III Study of ABI-007(Albumin-bound Paclitaxel) Plus Gemcitabine Versus Gemcitabine in Metastatic Adenocarcinoma of the Pancreas

A Randomized Phase III Study of Weekly ABI-007 Plus Gemcitabine Versus Gemcitabine Alone in Patients With Metastatic Adenocarcinoma of the Pancreas

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 861 (actual)
• Sponsor: Celgene · Industry
• Sex: All
• Age: 18 Years – 79 Years
• Healthy volunteers: Not accepted

Summary

Phase III Metastatic Pancreatic Cancer

Detailed description

A Phase III, open-label randomized, multicenter trial to compare ABI-007(Albumin-bound Paclitaxel)in combination with gemcitabine administered weekly to standard treatment (gemcitabine monotherapy) with respect to overall survival, objective tumor response rate and Progression Free Survival (PFS) in patients diagnosed with metastatic adenocarcinoma of the pancreas.

Conditions

• Metastatic Pancreatic Cancer

Interventions

Type	Name	Description
DRUG	Albumin-bound paclitaxel (ABI-007)	ABI-007 125 mg/m\^2 administered by intravenous infusion
DRUG	Gemcitabine	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).

Timeline

• Start date: 2009-03-01
• Primary completion: 2012-09-17
• Completion: 2013-04-09
• First posted: 2009-02-16
• Last updated: 2019-11-25
• Results posted: 2013-12-11

Locations

193 sites across 11 countries: United States, Australia, Austria, Belgium, Canada, France, Germany, Italy, Russia, Spain, Ukraine