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

This study has been completed.
Sponsor:
Collaborator:
OncoGenex Technologies
Information provided by (Responsible Party):
SCRI Development Innovations, LLC
ClinicalTrials.gov Identifier:
NCT01844817
First received: April 29, 2013
Last updated: April 11, 2017
Last verified: February 2017
Results First Received: February 8, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Participant, Care Provider, Investigator, Outcomes Assessor;   Primary Purpose: Treatment
Condition: Pancreatic Cancer
Interventions: Drug: OGX-427
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Between September 2013 and December 2014, 132 subjhects with untreated metastatic pancreatic cancer were enrolled in the trial from 11 U.S. investigational sites.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Subjects were enrolled and randomized in a 1:1 ratio (66 per Arm) to receive a combination of gemcitabine and nab-paclitaxel plus either OGX-427 (apatorsen) or a placebo.

Reporting Groups
  Description
OGX-427

OGX-427: Three separate loading doses at 600mg IV over 1 week prior to Cycle 1 of chemotherapy, followed by 600mg IV once weekly on Days 1, 8, 15, and 22 of each 28 day cycle concurrent with chemotherapy.

Chemotherapy: nab-paclitaxel (125mg/m^2 IV) and gemcitabine (1000mg/m^2 IV) on Days 1, 8, and 15 of each cycle. Patients continued 28 day treatment cycles until disease progression or until other reasons for discontinuation from treatment.

Placebo

Placebo (dextrose 5% in water): Three separate loading doses administered over 1 week prior to Cycle 1 of chemotherapy, followed by weekly doses on Days 1, 8, 15, and 22 of each 28 day cycle concurrent with chemotherapy.

Chemotherapy: nab-paclitaxel (125mg/m^2 IV) and gemcitabine (1000mg/m^2 IV) on Days 1, 8, and 15 of each cycle. Patients continued 28 day treatment cycles until disease progression or until other reasons for discontinuation from treatment.


Participant Flow for 2 periods

Period 1:   Enrolled and Randomized
    OGX-427   Placebo
STARTED   66   66 
COMPLETED [1]   64   63 
NOT COMPLETED   2   3 
Withdrawal by Subject                2                3 
[1] 5 patients withdrew prior to treatment.

Period 2:   Treatment
    OGX-427   Placebo
STARTED   64   63 
COMPLETED   0   0 
NOT COMPLETED   64   63 
Progressive Disease                27                36 
Adverse Event                17                9 
Withdrawal by Subject                10                6 
Death                10                8 
Lost to Follow-up                0                1 
Other                0                3 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Intent-to-Treat Population: All patients who met eligibility requirements and gave written informed consent.

Reporting Groups
  Description
OGX-427

OGX-427: Three separate loading doses at 600mg IV over 1 week prior to Cycle 1 of chemotherapy, followed by 600mg IV once weekly on Days 1, 8, 15, and 22 of each 28 day cycle concurrent with chemotherapy.

Chemotherapy: nab-paclitaxel (125mg/m^2 IV) and gemcitabine (1000mg/m^2 IV) on Days 1, 8, and 15 of each cycle. Patients continued 28 day treatment cycles until disease progression or until other reasons for discontinuation from treatment.

Placebo

Placebo (Dextrose 5% in Water): Three separate loading doses administered over 1 week prior to Cycle 1 of chemotherapy, followed by weekly doses on Days 1, 8, 15, and 22 of each 28 day cycle concurrent with chemotherapy.

Chemotherapy: nab-paclitaxel (125mg/m^2 IV) and gemcitabine (1000mg/m^2 IV) on Days 1, 8, and 15 of each cycle. Patients continued 28 day treatment cycles until disease progression or until other reasons for discontinuation from treatment.

Total Total of all reporting groups

Baseline Measures
   OGX-427   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 66   66   132 
Age 
[Units: Years]
Median (Full Range)
 66.5 
 (39 to 82) 
 65.5 
 (47 to 83) 
 66 
 (39 to 83) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      29  43.9%      28  42.4%      57  43.2% 
Male      37  56.1%      38  57.6%      75  56.8% 
Race/Ethnicity, Customized 
[Units: Participants]
Count of Participants
     
White   56   61   117 
Black/African American   10   5   15 
Region of Enrollment 
[Units: Participants]
     
United States   66   66   132 


  Outcome Measures
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1.  Primary:   Overall Survival   [ Time Frame: Up to 2 years ]

2.  Secondary:   Progression-Free Survival   [ Time Frame: Every 8 weeks up to 2 years ]

3.  Secondary:   Objective Response Rate   [ Time Frame: Every 8 weeks for up to 2 years ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Charles Davis, RAC
Organization: Sarah Cannon Development Innovations
e-mail: Charles.Davis2@scri-innovations.com



Responsible Party: SCRI Development Innovations, LLC
ClinicalTrials.gov Identifier: NCT01844817     History of Changes
Other Study ID Numbers: SCRI GI 184
Study First Received: April 29, 2013
Results First Received: February 8, 2017
Last Updated: April 11, 2017