DN24-02 as Adjuvant Therapy in Subjects With High Risk HER2+ Urothelial Carcinoma
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|ClinicalTrials.gov Identifier: NCT01353222|
Recruitment Status : Terminated (Administrative reasons.)
First Posted : May 13, 2011
Results First Posted : May 25, 2017
Last Update Posted : May 25, 2017
|Condition or disease||Intervention/treatment||Phase|
|Urothelial Carcinoma||Biological: DN24-02 Other: Standard of Care||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||142 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Randomized, Phase 2, Open-label Study Evaluating DN24-02 as Adjuvant Therapy in Subjects With High Risk HER2+ Urothelial Carcinoma|
|Study Start Date :||June 2011|
|Actual Primary Completion Date :||July 2015|
|Actual Study Completion Date :||July 2015|
Subjects received infusion of DN24-02, at 2-week intervals, for a total of 3 infusions.
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.
Other: Standard of Care
Observation only until documentation of disease recurrence.
- Overall Survival [ Time Frame: Subjects will be followed from baseline through the remainder of their lives or until study completion (approximately 60 months) ]
Overall survival is defined as the time from randomization to death due to any cause.
*This study was terminated early due to administrative reasons.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01353222
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|Study Director:||Robert Israel, MD||Valeant Pharmaceuticals North America LLC|