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

NCT00844649 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 861

Last updated 2019-11-25

Study results available
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Summary

Phase III Metastatic Pancreatic Cancer

Conditions

Interventions

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).

Sponsors & Collaborators

  • Celgene

    lead INDUSTRY

Principal Investigators

  • Daniel Von Hoff, MD · Scottsdale Clinical Research Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
79 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-03-01
Primary Completion
2012-09-17
Completion
2013-04-09

Countries

  • United States
  • Australia
  • Austria
  • Belgium
  • Canada
  • France
  • Germany
  • Italy
  • Russia
  • Spain
  • Ukraine

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00844649 on ClinicalTrials.gov