Clinical trialPhase 2Completed
Phase II Trial Of Gemcitabine Plus Nab-Paclitaxel +/- OGX-427 In Patients With Metastatic Pancreatic Cancer
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)
- Outcome
- Outcome unknown
- Phase
- Phase 2
- Status
- Completed
- Study type
- Interventional
- Start
- September 2013
- Expected end
- March 2016
- Enrollment
- 132 participants
- Sites
- 11
- Primary outcomes
- Overall Survival
- Sponsor
- Other
- Results posted
- 2017-05-16
- Last update
- 16 May 2017
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Brief summary public domain (ClinicalTrials.gov)
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 public domain (ClinicalTrials.gov)
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.
Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)
Overall Survival [Up to 2 years]. Median, months (95% Confidence Interval). OGX-427 (n=66): 5.3 (3.2 to 7.0); Placebo (n=66): 6.9 (5.8 to 9.3).
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Progression-Free Survival [Every 8 weeks up to 2 years]. Median, months (95% Confidence Interval). OGX-427 (n=66): 2.7 (2.2 to 3.7); Placebo (n=66): 3.8 (2.3 to 4.7).
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Objective Response Rate [Every 8 weeks for up to 2 years]. Number, percentage of participants. PR: OGX-427 (n=66): 18; Placebo (n=66): 18. CR: OGX-427 (n=66): 0; Placebo (n=66): 0.