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Trial record 1 of 1 for:    NCT01353222
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DN24-02 as Adjuvant Therapy in Subjects With High Risk HER2+ Urothelial Carcinoma

This study has been terminated.
(Administrative reasons.)
Sponsor:
Information provided by (Responsible Party):
Dendreon
ClinicalTrials.gov Identifier:
NCT01353222
First received: May 4, 2011
Last updated: April 21, 2017
Last verified: April 2017
Results First Received: March 8, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: No masking;   Primary Purpose: Treatment
Condition: Urothelial Carcinoma
Interventions: Biological: DN24-02
Other: Standard of Care

  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
DN24-02 DN24-02 is an autologous cellular immunotherapy product designed to stimulate an immune response against HER2/neu. It consists of autologous peripheral blood mononuclear cells (PBMCs), including antigen presenting cells (APCs), which are activated ex vivo with a recombinant fusion protein, BA7072.
Standard of Care Subjects randomized to the control arm were treated per standard of care, which in this patient population is generally observation, as there is currently no evidence that treatment with non-cisplatin-containing chemotherapy is beneficial in the adjuvant setting for this patient population.

Participant Flow:   Overall Study
    DN24-02   Standard of Care
STARTED   70   72 
DN24-02 Arm ≥1 Leukapheresis [1]   67   0 
Standard Care Arm ≥1 Post-baseline Visit [2]   0   72 
COMPLETED   0   0 
NOT COMPLETED   70   72 
Death                30                30 
Withdrawal by Subject                8                5 
Study Terminated                31                37 
Site closed research department                1                0 
[1] Safety population for the DN24-02 arm.
[2] Safety population for the Standard of Care arm.



  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

Reporting Groups
  Description
DN24-02 DN24-02 is an autologous cellular immunotherapy product designed to stimulate an immune response against HER2/neu. It consists of autologous peripheral blood mononuclear cells (PBMCs), including antigen presenting cells (APCs), which are activated ex vivo with a recombinant fusion protein, BA7072.
Standard of Care Subjects randomized to the control arm were treated per standard of care, which in this patient population is generally observation, as there is currently no evidence that treatment with non-cisplatin-containing chemotherapy is beneficial in the adjuvant setting for this patient population.
Total Total of all reporting groups

Baseline Measures
   DN24-02   Standard of Care   Total 
Overall Participants Analyzed 
[Units: Participants]
 70   72   142 
Age 
[Units: Participants]
Count of Participants
     
Participants Analyzed 
[Units: Participants]
 70   72   142 
<=18 years      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      33  47.1%      35  48.6%      68  47.9% 
>=65 years      37  52.9%      37  51.4%      74  52.1% 
Age 
[Units: Years]
Mean (Standard Deviation)
     
Participants Analyzed 
[Units: Participants]
 70   72   142 
   65.6  (10.81)   66.4  (10.09)   66.0  (10.42) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Participants Analyzed 
[Units: Participants]
 70   72   142 
Female      18  25.7%      19  26.4%      37  26.1% 
Male      52  74.3%      53  73.6%      105  73.9% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
     
Participants Analyzed 
[Units: Participants]
 70   72   142 
American Indian or Alaska Native      0   0.0%      0   0.0%      0   0.0% 
Asian      1   1.4%      2   2.8%      3   2.1% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      0   0.0% 
Black or African American      4   5.7%      0   0.0%      4   2.8% 
White      65  92.9%      70  97.2%      135  95.1% 
More than one race      0   0.0%      0   0.0%      0   0.0% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0% 
Region of Enrollment 
[Units: Participants]
Count of Participants
     
United States       
Participants Analyzed 
[Units: Participants]
 70   72   142 
United States   70   72   142 
Body weight [1] 
[Units: Kilograms]
Mean (Standard Deviation)
     
Participants Analyzed 
[Units: Participants]
 70   71   141 
   80.770  (18.3080)   82.115  (17.9330)   81.448  (18.0679) 
[1] Baseline weight for one subject in standard of care group is missing.
Eastern Cooperative Oncology Group (ECOG) Performance Status [1] [2] 
[Units: Participants]
Count of Participants
     
ECOG 0=Fully Active; No restrictions       
Participants Analyzed 
[Units: Participants]
 69   71   140 
ECOG 0=Fully Active; No restrictions   42   38   80 
ECOG 1= Restricted Strenuous Activity       
Participants Analyzed 
[Units: Participants]
 69   71   140 
ECOG 1= Restricted Strenuous Activity   24   31   55 
ECOG 2=Ambulatory, capable of self-care; no work       
Participants Analyzed 
[Units: Participants]
 69   71   140 
ECOG 2=Ambulatory, capable of self-care; no work   3   2   5 
[1] ECOG Performance Status is a method used to assess the functional status of a patient. The scale ranges from 0-5. 0=Fully active, able to carry on all pre-disease performance without restriction; 1=Restricted in physically strenuous activity but ambulatory and able to carry out light or sedentary work; 2=Ambulatory, capable of all self-care but unable to carry out work activities. Up and about >50% of waking hour; 3=Capable of limited self-care, confined to bed or chair >50% of waking hours; 4=Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair; 5=Dead
[2] Baseline ECOG data is missing for one subject in each group.


  Outcome Measures

1.  Primary:   Overall Survival   [ Time Frame: Subjects will be followed from baseline through the remainder of their lives or until study completion (approximately 60 months) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide 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
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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: Shabnam Vaziri
Organization: Dendreon
phone: 206-455-2323
e-mail: svaziri@dendreon.com



Responsible Party: Dendreon
ClinicalTrials.gov Identifier: NCT01353222     History of Changes
Other Study ID Numbers: N10-1
Study First Received: May 4, 2011
Results First Received: March 8, 2017
Last Updated: April 21, 2017