Phase 2 Study to Assess the Efficacy & Safety of Gemcitabine + Nab Paclitaxel With or Without Dociparstat in Metastatic Pancreatic Cancer Patients

PHASE2TerminatedINTERVENTIONAL
Enrollment

60

Participants

Timeline

Start Date

November 30, 2011

Primary Completion Date

December 31, 2012

Study Completion Date

June 30, 2015

Conditions
Metastatic Pancreatic Cancer
Interventions
DRUG

Nab paclitaxel

Nab-paclitaxel 125 mg/m2 will be administered IV over 30 minutes. Nab-paclitaxel will be administered weekly for 3 weeks followed by 1 week of rest (28-day cycle).

DRUG

Gemcitabine

Following the completion of nab-paclitaxel administration, gemcitabine IV infusion at 1000 mg/m2 will be administered over 30 minutes. Gemcitabine will be administered weekly for 3 weeks followed by 1 week of rest (28-cycle).

DRUG

Dociparstat

Following the completion of gemcitabine administration, dociparstat IV bolus at 4 mg/kg will be administered in 5 minutes immediately after completion of gemcitabine administration. Immediately following the dociparstat IV bolus administration, dociparstat 48-hour IV continuous infusion at 0.375 mg/kg/hr will be administered.

Trial Locations (16)

15232

UPMC Cancer Center, Pittsburgh

19107

Thomas Jefferson University [Kimmel Cancer Center], Philadelphia

19111

Fox Chase Cancer Center, Philadelphia

29425

Medical University of South Carolina Hollings Cancer Center, Charleston

33331

Cleveland Clinic Florida, Weston

44304

Summa Health System - Cooper Cancer Center, Akron

46526

Indiana University Health, Goshen Center for Cancer Care, Goshen

49503

Saint Mary's Health Care, Grand Rapids

60153

Loyola University Medical Center/Cardinal Bernardin Cancer Center, Maywood

71130

Fesit-Weiller Cancer Center, Shreveport

77555

University of Texas Medical Branch, Galveston

78229

South Texas Oncology & Hematology, San Antonio

85259

Mayo Clinic Arizona, Scottsdale

91505

Disney Family Cancer Center, Burbank

92037

Scripps Clinic Torrey Pines ( Green Hospital), La Jolla

94904

Marin Cancer Care, Greenbrae

Sponsors
All Listed Sponsors
collaborator

Translational Drug Development

OTHER

lead

Jazz Pharmaceuticals

INDUSTRY