Spots Global Cancer Trial Database for Phase II Trial Of Gemcitabine Plus Nab-Paclitaxel +/- OGX-427 In Patients With Metastatic Pancreatic Cancer
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Trial Identification
Brief Title: Phase II Trial Of Gemcitabine Plus Nab-Paclitaxel +/- OGX-427 In Patients With Metastatic Pancreatic Cancer
Official Title: A Randomized, Double-Blinded, Placebo-Controlled Phase II Trial Of Gemcitabine Plus Nab-Paclitaxel Combined With OGX-427 Or Placebo In Patients With Metastatic Pancreatic Cancer (The Rainier Trial)
Study ID: NCT01844817
Conditions
Study Description
Brief Summary: The purpose of this study is to compare the overall survival in patients with previously untreated metastatic pancreatic cancer receiving gemcitabine/nab-paclitaxel plus OGX-427 or gemcitabine/nab-paclitaxel plus placebo.
Detailed Description: Patients with pancreatic cancer usually present with inoperable disease and systemic therapy becomes the primary form of treatment. The combination of gemcitabine plus nab-paclitaxel represents an appropriate front-line standard of care for patients with metastatic pancreatic cancer. However, poor outcomes with this disease warrant exploration of novel drugs with unique mechanisms of action. Preclinical evidence suggests that OGX-427 has shown promising activity in pancreatic cancer. In this trial, we will compare the overall survival of patients with previously untreated metastatic pancreatic cancer using OGX-427 with either gemcitabine/nab-paclitaxel or a placebo with gemcitabine/nab-paclitaxel.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
University of California-San Francisco, San Francisco, California, United States
Florida Cancer Specialists-South, Ft. Myers, Florida, United States
Florida Hospital Cancer Insitute, Orlando, Florida, United States
Florida Cancer Specialists-North, St. Petersburg, Florida, United States
Ingalls Cancer Research Center, Harvey, Illinois, United States
Oncology Hematology Care, Inc., Cincinnati, Ohio, United States
South Carolina Oncology Associates, Columbia, South Carolina, United States
Tennessee Oncology - Chattanooga, Chattanooga, Tennessee, United States
Tennessee Oncology, PLLC, Nashville, Tennessee, United States
The Center for Cancer and Blood Disorders, Fort Worth, Texas, United States
Virginia Cancer Institute, Richmond, Virginia, United States
Contact Details
Name: Johanna Bendell, M.D.
Affiliation: SCRI
Role: STUDY_CHAIR
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