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Phase 2 Study of Docetaxel +/- OGX-427 in Patients With Relapsed or Refractory Metastatic Bladder Cancer

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01780545
First Posted: January 31, 2013
Last Update Posted: November 14, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Achieve Life Sciences
Hoosier Cancer Research Network
Information provided by (Responsible Party):
Noah Hahn, M.D., Hoosier Cancer Research Network
Results First Submitted: October 18, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Bladder Cancer
Urothelial Carcinoma
Interventions: Drug: OGX-427
Drug: 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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Experimental Arm: Arm A

Three doses of 600 mg OGX-427 will be administered IV during the loading dose period (days -9 to -1). Following completion of the loading dose period, 600 mg OGX-427 will be given IV weekly on days 1, 8, and 15 of each 21-day cycle. OGX-427 must be administered prior to docetaxel on day 1 of each cycle.

Following completion of 10 cycles of docetaxel, 600 mg OGX-427 will continue to be administered by IV weekly as maintenance therapy in Arm A participants who do not have disease progression (i.e., stable disease or better). Maintenance with OGX-427 will continue until disease progression or unacceptable toxicity.

Docetaxel: For Arm A Only: Docetaxel should be administered immediately following the completion of the OGX-427 infusion.

For Both Arms: Docetaxel (75 mg/M2) will be administered IV on Day 1 of each 21 day cycle for a maximum of 10 cycles.

Control Arm: Arm B

Docetaxel (75 mg/M2) will be administered IV on day 1 of each 21 day cycle for a maximum of 10 cycles.

Docetaxel: For Arm A Only: Docetaxel should be administered immediately following the completion of the OGX-427 infusion.

For Both Arms: Docetaxel (75 mg/M2) will be administered IV on Day 1 of each 21 day cycle for a maximum of 10 cycles.


Participant Flow:   Overall Study
    Experimental Arm: Arm A   Control Arm: Arm B
STARTED   99   101 
COMPLETED   95   99 
NOT COMPLETED   4   2 
Withdrawal by Subject                3                1 
Lost to Follow-up                1                1 



  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.
No text entered.

Reporting Groups
  Description
Experimental Arm: Arm A

Three doses of 600 mg OGX-427 will be administered IV during the loading dose period (days -9 to -1). Following completion of the loading dose period, 600 mg OGX-427 will be given IV weekly on days 1, 8, and 15 of each 21-day cycle. OGX-427 must be administered prior to docetaxel on day 1 of each cycle.

Following completion of 10 cycles of docetaxel, 600 mg OGX-427 will continue to be administered by IV weekly as maintenance therapy in Arm A participants who do not have disease progression (i.e., stable disease or better). Maintenance with OGX-427 will continue until disease progression or unacceptable toxicity.

Docetaxel: For Arm A Only: Docetaxel should be administered immediately following the completion of the OGX-427 infusion.

For Both Arms: Docetaxel (75 mg/M2) will be administered IV on Day 1 of each 21 day cycle for a maximum of 10 cycles.

Control Arm: Arm B

Docetaxel (75 mg/M2) will be administered IV on day 1 of each 21 day cycle for a maximum of 10 cycles.

Docetaxel: For Arm A Only: Docetaxel should be administered immediately following the completion of the OGX-427 infusion.

For Both Arms: Docetaxel (75 mg/M2) will be administered IV on Day 1 of each 21 day cycle for a maximum of 10 cycles.

Total Total of all reporting groups

Baseline Measures
   Experimental Arm: Arm A   Control Arm: Arm B   Total 
Overall Participants Analyzed 
[Units: Participants]
 99   101   200 
Age 
[Units: Years]
Median (Full Range)
 68 
 (43 to 90) 
 67 
 (35 to 92) 
 67 
 (35 to 92) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      25  25.3%      26  25.7%      51  25.5% 
Male      74  74.7%      75  74.3%      149  74.5% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
     
Hispanic or Latino      4   4.0%      2   2.0%      6   3.0% 
Not Hispanic or Latino      94  94.9%      98  97.0%      192  96.0% 
Unknown or Not Reported      1   1.0%      1   1.0%      2   1.0% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
     
American Indian or Alaska Native      0   0.0%      0   0.0%      0   0.0% 
Asian      5   5.1%      3   3.0%      8   4.0% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      0   0.0% 
Black or African American      3   3.0%      4   4.0%      7   3.5% 
White      89  89.9%      92  91.1%      181  90.5% 
More than one race      0   0.0%      0   0.0%      0   0.0% 
Unknown or Not Reported      2   2.0%      2   2.0%      4   2.0% 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Overall Survival   [ Time Frame: 36 Months ]

2.  Secondary:   Safety and Toxicity of Regimen   [ Time Frame: 36 Months ]

3.  Secondary:   Overall Response Rate   [ Time Frame: Every 6 weeks ]

4.  Secondary:   Overall Survival (OS) According to Baseline Serum Hsp27 Level.   [ Time Frame: 36 months ]

5.  Secondary:   Hsp27 Expression in Archival Tissue   [ Time Frame: Cycle 1 ]

6.  Secondary:   Effect of Therapy Regimen on Circulating Tumor Cells (CTCs)and Correlative Analysis of Telomerase Activity   [ Time Frame: Prior to screening, prior to first loading dose, and prior to cycles 1, 2, 3 and 5 ]


  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 NOT 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.


Results Point of Contact:  
Name/Title: Clinical Data Manager
Organization: Hoosier Cancer Research Network
phone: 3176345842 ext 41
e-mail: hcrndm@hoosiercancer.org


Publications:
Jonathan E. Rosenberg, Noah M. Hahn, Meredith M. Regan, Cindy Jacobs, Patricia S. Stewart, Toni K. Choueiri. The Borealis-2 clinical trial: A randomized phase II study of OGX-427 plus docetaxel versus docetaxel alone in relapsed/refractory metastatic urothelial cancer. J Clin Oncol 31, 2013 (suppl; abstr TPS4588^) http://abstracts2.asco.org/AbstView_132_114639.html
Choueiri TK, Hahn NM, Pal SK, Alva AS, Dreicer R, Starodub A, Sonpavde G, Hoffman-Censits JH, Picus J, Balar AV, Guancial EA, Regan MM, Jacobs C, Stewart PS, Rosenberg JE. The Borealis-2 clinical trial: A randomized phase 2 study of OGX-427 (apatorsen) plus docetaxel versus docetaxel alone in relapsed/refractory metastatic urothelial cancer. J Clin Oncol 32:5s, 2014 (suppl; abstr TPS4593^)
Choueiri TK, Hahn NM, Alva AS, Lauer RC, Dreicer R, Picus J, Pili R, Balar AV, Sonpavde G, Hoffman-Censits JH, Guancial EA, Alter R, Regan MM, Jacobs C, Stewart PS, Pal SK, Rosenberg JE. The Borealis-2 clinical trial: A randomized phase 2 study of OGX-427 (Apatorsen) plus docetaxel versus docetaxel alone in relapsed/refractory metastatic urothelial cancer. J Clin Oncol 33:5s, 2015 (suppl; abstr TPS4577)


Responsible Party: Noah Hahn, M.D., Hoosier Cancer Research Network
ClinicalTrials.gov Identifier: NCT01780545     History of Changes
Other Study ID Numbers: GU12-160
First Submitted: January 25, 2013
First Posted: January 31, 2013
Results First Submitted: October 18, 2017
Results First Posted: November 14, 2017
Last Update Posted: November 14, 2017