Phase II Trial Of Gemcitabine Plus Nab-Paclitaxel +/- OGX-427 In Patients With Metastatic Pancreatic Cancer (Rainier)
|ClinicalTrials.gov Identifier: NCT01844817|
Recruitment Status : Completed
First Posted : May 1, 2013
Results First Posted : May 16, 2017
Last Update Posted : May 16, 2017
|Condition or disease||Intervention/treatment||Phase|
|Pancreatic Cancer||Drug: OGX-427 Drug: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||132 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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 Start Date :||September 2013|
|Actual Primary Completion Date :||March 2016|
|Actual Study Completion Date :||March 2016|
Three loading doses of OGX-427 at 600mg IV will be administered Days -9 to -1. Following the loading dose period, OGX-427 will be administered at 600mg IV weekly Days 1, 8, 15, and 22 of each 28 day cycle during the Treatment Phase.
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.
Placebo Comparator: Placebo
Three loading doses of placebo will be administered Days -9 to -1. Following the loading dose period, placebo will be administered weekly Days 1, 8, 15, and 22 of each 28 day cycle.
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.
- Overall Survival [ Time Frame: Up to 2 years ]Overall survival defined as the time, in months, from date of randomization until date of death or date last known alive whichever comes first, assessed up to 2 years.
- Progression-Free Survival [ Time Frame: Every 8 weeks up to 2 years ]The time (in months) that patients are progression-free, assessed from date of randomization to date of first documented disease progression or date of death from any cause, whichever comes first. Progression is defined according to Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.1), as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest (nadir) sum while on study (this includes the baseline sum if that is the smallest on study), or the appearance of one or more new lesions.
- Objective Response Rate [ Time Frame: Every 8 weeks for up to 2 years ]Objective response rate defined as the percent of patients having a complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. CR=complete disappearance of all target lesions. PR=decrease in baseline of 30% or more of the diameter(s) of all target lesions.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01844817
|United States, California|
|University of California-San Francisco|
|San Francisco, California, United States, 94115|
|United States, Florida|
|Florida Cancer Specialists-South|
|Ft. Myers, Florida, United States, 33916|
|Florida Hospital Cancer Insitute|
|Orlando, Florida, United States, 32804|
|Florida Cancer Specialists-North|
|St. Petersburg, Florida, United States, 33705|
|United States, Illinois|
|Ingalls Cancer Research Center|
|Harvey, Illinois, United States, 60426|
|United States, Ohio|
|Oncology Hematology Care, Inc.|
|Cincinnati, Ohio, United States, 45242|
|United States, South Carolina|
|South Carolina Oncology Associates|
|Columbia, South Carolina, United States, 29210|
|United States, Tennessee|
|Tennessee Oncology - Chattanooga|
|Chattanooga, Tennessee, United States, 37404|
|Tennessee Oncology, PLLC|
|Nashville, Tennessee, United States, 37203|
|United States, Texas|
|The Center for Cancer and Blood Disorders|
|Fort Worth, Texas, United States, 76104|
|United States, Virginia|
|Virginia Cancer Institute|
|Richmond, Virginia, United States, 23230|
|Study Chair:||Johanna Bendell, M.D.||SCRI|