Phase II Trial Of Gemcitabine Plus Nab-Paclitaxel +/- OGX-427 In Patients With Metastatic Pancreatic Cancer

PHASE2CompletedINTERVENTIONAL
Enrollment

132

Participants

Timeline

Start Date

September 30, 2013

Primary Completion Date

March 31, 2016

Study Completion Date

March 31, 2016

Conditions
Pancreatic Cancer
Interventions
DRUG

OGX-427

Three separate administrations of OGX-427 will be given during the 9-day Loading Dose Period. Following the Loading Dose Period, patients will receive 600mg OGX-427 prior to the administration of nab-paclitaxel (125mg/m2 IV)and gemcitabine (1000mg/m2 IV)administration on Day 1, 8, and 15 of each cycle. OGX-427 will also be administered on Day 22 during each cycle (i.e., weekly). Patients will continue 28 day treatment cycles until disease progression or until other reasons for discontinuation from treatment.

DRUG

Placebo

Three separate administrations of Placebo will be given during the 9-day Loading Dose Period. Following the Loading Dose Period, patients will receive placebo prior to the administration of nab-paclitaxel (125mg/m2 IV)and gemcitabine (1000mg/m2 IV)administration on Day 1, 8, and 15 of each cycle. Placebo will also be administered on Day 22 during each cycle (i.e., weekly). Patients will continue 28 day treatment cycles until disease progression or until other reasons for discontinuation from treatment.

Trial Locations (11)

23230

Virginia Cancer Institute, Richmond

29210

South Carolina Oncology Associates, Columbia

32804

Florida Hospital Cancer Insitute, Orlando

33705

Florida Cancer Specialists-North, St. Petersburg

33916

Florida Cancer Specialists-South, Fort Myers

37203

Tennessee Oncology, PLLC, Nashville

37404

Tennessee Oncology - Chattanooga, Chattanooga

45242

Oncology Hematology Care, Inc., Cincinnati

60426

Ingalls Cancer Research Center, Harvey

76104

The Center for Cancer and Blood Disorders, Fort Worth

94115

University of California-San Francisco, San Francisco

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Achieve Life Sciences

INDUSTRY

lead

SCRI Development Innovations, LLC

OTHER