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Evaluation of Safety and Feasibility of OGX-011 in Combination With 2nd-line Chemotherapy in Patients With HRPC

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
OncoGenex Technologies
ClinicalTrials.gov Identifier:
NCT00327340
First received: May 16, 2006
Last updated: October 2, 2012
Last verified: October 2012
History of Changes
Results First Received: July 26, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Prostate Cancer
Interventions: Drug: custirsen (OGX-011)/mitoxantrone
Drug: custirsen (OGX-011)/docetaxel

  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
Participants were recruited at 10 institutions with a primary focus in oncology and located in Canada. The first subject was randomized on July 25, 2006. The last subject completed treatment on August 6, 2008 and the last survival follow-up visit was on August 13, 2010

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 70 subjects were enrolled. 45 subjects were randomly assigned to treatment (21 to OGX-011/ docetaxel and 24 OGX-011/ mitoxantrone). An additional 25 subjects were enrolled under Amendment 2 and assigned to OGX-011/docetaxel retreatment. One subject was found to be ineligible and was not treated.

Reporting Groups
  Description
OGX-011 / Mitoxantrone/Prednisone All subjects began with oral prednisone (5 mg twice daily)on Day-10. Custirsen (OGX-011) was infused intravenously over 2 hours on Day -7, -5 and-3 of cycle 1 (Pretreatment loading doses). OGX-011 was then infused for 2 hours on Days 1, 8, and 15 of each 21-day cycle. Mitoxantrone was infused at a dose of 12 mg/m² over 30 minutes on day 1 of each cycle.
OGX-011 / Docetaxel/Prednisone All subjects began with oral prednisone (5 mg twice daily)on Day-10. Custirsen (OGX-011) was infused intravenously over 2 hours on Day -7, -5 and -3 of cycle 1 (Pretreatment loading doses). OGX-011 was then to be infused for 2 hours on Days 1, 8, and 15 of each 21-day cycle. Docetaxel was infused at a dose of 75 mg/m² over 60 minutes on day 1 of each cycle.

Participant Flow:   Overall Study
    OGX-011 / Mitoxantrone/Prednisone     OGX-011 / Docetaxel/Prednisone  
STARTED     23     46  
COMPLETED     8     16  
NOT COMPLETED     15     30  
Withdrawal by Subject                 1                 5  
Physician Decision                 1                 1  
Disease Progression                 10                 19  
Symptomatic Disease                 0                 2  
Adverse Event                 3                 3  



  Baseline Characteristics
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Reporting Groups
  Description
OGX-011 / Mitoxantrone/Prednisone All subjects began with oral prednisone (5 mg twice daily)on Day-10. Custirsen (OGX-011) was infused intravenously over 2 hours on Day -7, -5 and-3 of cycle 1 (Pretreatment loading doses). OGX-011 was then infused for 2 hours on Days 1, 8, and 15 of each 21-day cycle. Mitoxantrone was infused at a dose of 12 mg/m² over 30 minutes on day 1 of each cycle.
OGX-011 / Docetaxel/Prednisone All subjects began with oral prednisone (5 mg twice daily)on Day-10. Custirsen (OGX-011) was infused intravenously over 2 hours on Day -7, -5 and -3 of cycle 1 (Pretreatment loading doses). OGX-011 was then to be infused for 2 hours on Days 1, 8, and 15 of each 21-day cycle. Docetaxel was infused at a dose of 75 mg/m² over 60 minutes on day 1 of each cycle.
Total Total of all reporting groups

Baseline Measures
    OGX-011 / Mitoxantrone/Prednisone     OGX-011 / Docetaxel/Prednisone     Total  
Number of Participants  
[units: participants]
 		  23     46     69  
Age  
[units: years]
Median ( Full Range ) 		  61  
  ( 49 to 81 )   		  64  
  ( 48 to 80 )   		  63  
  ( 48 to 81 )  
Gender  
[units: participants]
 		     
Female     0     0     0  
Male     23     46     69  
Race (NIH/OMB)  
[units: participants]
 		     
American Indian or Alaska Native     0     0     0  
Asian     0     1     1  
Native Hawaiian or Other Pacific Islander     0     0     0  
Black or African American     0     3     3  
White     21     42     63  
More than one race     0     0     0  
Unknown or Not Reported     2     0     2  
Karnofsky Score [1]
[units: participants]
 		     
60-70%     2     6     8  
80%     7     13     20  
90%     7     22     29  
100%     7     5     12  
[1]

The Karnofsky Performance Scale Index allows patients to be classified as to their functional impairment.

100%=Normal no complaints; no evidence of disease 90%=Able to carry on normal activity; minor signs or symptoms of disease 80%=Normal activity with effort;some signs or symptoms of disease 60-70%=Able to care for self;unable to do active work



  Outcome Measures
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1.  Primary:   Safety and Tolerability of Custirsen (OGX-011) in Combination With Either Docetaxel/Prednisone or Mitoxantrone/Prednisone as Second-line Chemotherapy.   [ Time Frame: Subjects were followed for safety from enrollment for up to 8 months (9 three-week cycles plus 30 days after end of treatment) ]
  Show Outcome Measure 1

2.  Secondary:   Feasibility of Treatment With Custirsen (OGX-011) in Combination With Second-line Chemotherapy Based on Prostate Specific Antigen (PSA) Response   [ Time Frame: PSA was evaluated at screening, on Day 1 of each cycle, at the end of treatment visit and during off-treatment follow up (up to 27 months) ]
  Show Outcome Measure 2

3.  Secondary:   Feasibility of Treatment With OGX-011 in Combination With Either Docetaxel/Prednisone or Mitoxantrone/Prednisone as Second Line Chemotherapy Based on Time to Pain Progression   [ Time Frame: Enrollment until pain progression (up to 21 months) ]
  Show Outcome Measure 3

4.  Secondary:   Relationship Between Changes in Serum Clusterin Levels and Change in Serum PSA Levels When OGX-011 in Combination With Either Docetaxel/Prednisone or Mitoxantrone/Prednisone is Administered as Second Line Chemotherapy.   [ Time Frame: Enrollment until disease progression (up to 13 months) ]
  Show Outcome Measure 4


  Serious Adverse Events
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  Other Adverse Events
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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.


Limitations and Caveats
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
No text entered.  


Results Point of Contact:  
Name/Title: Monica S. Krieger, PhD
Organization: OncoGenex Pharmaceuticals
phone: 425-686-1558
e-mail: mkrieger@oncogenex.com


Publications of Results:


Responsible Party: OncoGenex Technologies
ClinicalTrials.gov Identifier: NCT00327340     History of Changes
Other Study ID Numbers: OGX-011-07
Study First Received: May 16, 2006
Results First Received: July 26, 2012
Last Updated: October 2, 2012
Health Authority: United States: Food and Drug Administration
Canada: Health Canada