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Safety and Efficacy Studies of Panobinostat and Bicalutamide in Patients With Recurrent Prostate Cancer After Castration

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ClinicalTrials.gov Identifier: NCT00878436
Recruitment Status : Completed
First Posted : April 9, 2009
Results First Posted : December 4, 2017
Last Update Posted : February 7, 2018
Sponsor:
Collaborator:
Novartis
Information provided by (Responsible Party):
New York University School of Medicine

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Prostate Cancer
Prostatic Neoplasms
Interventions: Drug: Panobinostat
Drug: Bicalutamide

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Members of the research team have attempted to contact the PI, unsuccessfully, and are unable to answer questions regarding results.

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
LBH 40mg Participants assigned to this arm received 40mg of LBH589 (LBH) three times a week (for a total weekly dose of 120mg). Additionally, they received 50mg of bicalutamide (Bic) daily.
LBH 20mg Participants assigned to this arm received 20mg of LBH589 (LBH) three times a week (for a total weekly dose of 60mg). Additionally, they received 50mg of bicalutamide (Bic) daily.

Participant Flow:   Overall Study
    LBH 40mg   LBH 20mg
STARTED   28   24 
Completed 2 Cycles   21   20 
6 Months   8   0 
COMPLETED   5   0 
NOT COMPLETED   23   24 



  Baseline Characteristics

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
LBH 40mg Participants assigned to this arm received 40mg of LBH589 (LBH) three times a week (for a total weekly dose of 120mg). Additionally, they received 50mg of bicalutamide (Bic) daily.
LBH 20mg Participants assigned to this arm received 20mg of LBH589 (LBH) three times a week (for a total weekly dose of 60mg). Additionally, they received 50mg of bicalutamide (Bic) daily.
Total Total of all reporting groups

Baseline Measures
   LBH 40mg   LBH 20mg   Total 
Overall Participants Analyzed 
[Units: Participants]
 28   24   52 
Age 
[Units: Years]
Median (Full Range)
 69 
 (48 to 84) 
 69 
 (50 to 83) 
 69 
 (48 to 84) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      0   0.0%      0   0.0%      0   0.0% 
Male      28 100.0%      24 100.0%      52 100.0% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
     
American Indian or Alaska Native      0   0.0%      0   0.0%      0   0.0% 
Asian      0   0.0%      1   4.2%      1   1.9% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      0   0.0% 
Black or African American      3  10.7%      1   4.2%      4   7.7% 
White      25  89.3%      22  91.7%      47  90.4% 
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% 


  Outcome Measures

1.  Primary:   Percentage of Patients Free of Progression and Without Symptomatic Deterioration   [ Time Frame: 9 months ]

2.  Primary:   Percentage of Patients Free of Progression and Without Symptomatic Deterioration   [ Time Frame: 6 months ]

3.  Secondary:   Time to PSA Progression   [ Time Frame: up to 2 years ]

4.  Secondary:   Number of Patients That Achieve a 50% or Greater PSA Decline by 9 Months of Therapy   [ Time Frame: 9 months ]


  Serious Adverse Events


  Other Adverse Events


  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.


  More Information

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: Fraustina Hsu
Organization: NYU Langone Medical Center
phone: 646 754 712
e-mail: fraustina.hsu@nyumc.org



Responsible Party: New York University School of Medicine
ClinicalTrials.gov Identifier: NCT00878436     History of Changes
Other Study ID Numbers: 08-479
First Submitted: April 8, 2009
First Posted: April 9, 2009
Results First Submitted: September 1, 2016
Results First Posted: December 4, 2017
Last Update Posted: February 7, 2018