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Trial record 97 of 103 for:    "Kennedy disease"

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

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.
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
Enrollment 52
Recruitment Details Members of the research team have attempted to contact the PI, unsuccessfully, and are unable to answer questions regarding results.
Pre-assignment Details  
Arm/Group Title LBH 40mg LBH 20mg
Hide Arm/Group Description 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. 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.
Period Title: Overall Study
Started 28 24
Completed 2 Cycles 21 20
6 Months 8 0
Completed 5 0
Not Completed 23 24
Arm/Group Title LBH 40mg LBH 20mg Total
Hide Arm/Group Description 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. 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 of all reporting groups
Overall Number of Baseline Participants 28 24 52
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 28 participants 24 participants 52 participants
69
(48 to 84)
69
(50 to 83)
69
(48 to 84)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 28 participants 24 participants 52 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
Male
28
 100.0%
24
 100.0%
52
 100.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 28 participants 24 participants 52 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%
1.Primary Outcome
Title Percentage of Patients Free of Progression and Without Symptomatic Deterioration
Hide Description

measured by PSA and /or metastases progression criteria by body CT following RECIST criteria 1.1 and/or bones scan following the appearance of at least 2 new bone metastases and confirmation of 2 additional bone metastasis on a subsequent bone scan 6-8 weeks later and/or clinical progression.

Only participants who completed two or more treatment cycles were assessed for this outcome measure.

Time Frame 9 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title LBH 40mg LBH 20mg
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 21 20
Measure Type: Number
Unit of Measure: percentage of Participants
24 9
2.Primary Outcome
Title Percentage of Patients Free of Progression and Without Symptomatic Deterioration
Hide Description

measured by PSA and /or metastases progression criteria by body CT following RECIST criteria 1.1 and/or bones scan following the appearance of at least 2 new bone metastases and confirmation of 2 additional bone metastasis on a subsequent bone scan 6-8 weeks later and/or clinical progression.

Only participants who completed two or more treatment cycles were assessed for this outcome measure.

Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title LBH 40mg LBH 20mg
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 21 20
Measure Type: Number
Unit of Measure: percentage of participants
42 19
3.Secondary Outcome
Title Time to PSA Progression
Hide Description PSA progression is defined as a 25% or greater increase in PSA and an absolute increase value of 2 ng/ml or more over a nadir or baseline documented and confirmed by a second value three weeks later
Time Frame up to 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
Unable to locate PI for secondary outcome measure results. Data is not available.
Arm/Group Title LBH 40mg LBH 20mg
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
4.Secondary Outcome
Title Number of Patients That Achieve a 50% or Greater PSA Decline by 9 Months of Therapy
Hide Description Unable to locate PI for secondary outcome measure results. Data is not available.
Time Frame 9 months
Hide Outcome Measure Data
Hide Analysis Population Description
Unable to locate PI for secondary outcome measure results. Data is not available.
Arm/Group Title LBH 40mg LBH 20mg
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title LBH 40mg LBH 20mg
Hide Arm/Group Description 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. 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.
All-Cause Mortality
LBH 40mg LBH 20mg
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
LBH 40mg LBH 20mg
Affected / at Risk (%) Affected / at Risk (%)
Total   11/28 (39.29%)   5/24 (20.83%) 
Blood and lymphatic system disorders     
Myelodysplasia  0/28 (0.00%)  1/24 (4.17%) 
Pancytopenia  0/28 (0.00%)  1/24 (4.17%) 
Subarachoid Hemorrhage  0/28 (0.00%)  1/24 (4.17%) 
Subdural Hematoma  0/28 (0.00%)  1/24 (4.17%) 
Thrombocytopenia  5/28 (17.86%)  0/24 (0.00%) 
Cardiac disorders     
Cardiac Asystole  0/28 (0.00%)  1/24 (4.17%) 
Qtc Prolonged  1/28 (3.57%)  0/24 (0.00%) 
Gastrointestinal disorders     
Dehydration  1/28 (3.57%)  2/24 (8.33%) 
Diarrhea  1/28 (3.57%)  0/24 (0.00%) 
Nausea  1/28 (3.57%)  0/24 (0.00%) 
Stomach Pain  1/28 (3.57%)  0/24 (0.00%) 
Ulcers  1/28 (3.57%)  0/24 (0.00%) 
Vomiting  2/28 (7.14%)  0/24 (0.00%) 
General disorders     
Chest Pain  1/28 (3.57%)  0/24 (0.00%) 
Fatigue  1/28 (3.57%)  0/24 (0.00%) 
Fever  1/28 (3.57%)  0/24 (0.00%) 
Karposi Sarcoma  0/28 (0.00%)  1/24 (4.17%) 
Metabolism and nutrition disorders     
Hyperglycemia  1/28 (3.57%)  0/24 (0.00%) 
Hypokalemia  0/28 (0.00%)  1/24 (4.17%) 
Nervous system disorders     
Dizziness  0/28 (0.00%)  1/24 (4.17%) 
Syncope  3/28 (10.71%)  1/24 (4.17%) 
Renal and urinary disorders     
Acute Renal Failure  1/28 (3.57%)  0/24 (0.00%) 
Surgical and medical procedures     
Cord Compression  1/28 (3.57%)  0/24 (0.00%) 
Pleural Effusion  0/28 (0.00%)  1/24 (4.17%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
LBH 40mg LBH 20mg
Affected / at Risk (%) Affected / at Risk (%)
Total   26/28 (92.86%)   24/24 (100.00%) 
Blood and lymphatic system disorders     
Anc  0/28 (0.00%)  1/24 (4.17%) 
Anemia  3/28 (10.71%)  3/24 (12.50%) 
Bilateral Lower Extremity Edema  1/28 (3.57%)  0/24 (0.00%) 
Bruising  1/28 (3.57%)  0/24 (0.00%) 
Decreased Platelets  1/28 (3.57%)  0/24 (0.00%) 
Edema- Leg  1/28 (3.57%)  0/24 (0.00%) 
Edema- Pedal  1/28 (3.57%)  0/24 (0.00%) 
Enlarged L Neck Node (Bl)  1/28 (3.57%)  0/24 (0.00%) 
L Eye Conjunctival Hemorrhage  1/28 (3.57%)  0/24 (0.00%) 
Left Scleral Hemorrhage  1/28 (3.57%)  0/24 (0.00%) 
Leg Edema  1/28 (3.57%)  0/24 (0.00%) 
Leukopenia  1/28 (3.57%)  0/24 (0.00%) 
Low Platelets  1/28 (3.57%)  0/24 (0.00%) 
Lower Extremity Edema  1/28 (3.57%)  0/24 (0.00%) 
Neutropenia  5/28 (17.86%)  0/24 (0.00%) 
Nose Bleeds  1/28 (3.57%)  0/24 (0.00%) 
Petechial Rash (Arms & Legs)  1/28 (3.57%)  0/24 (0.00%) 
Platelets  1/28 (3.57%)  0/24 (0.00%) 
Platelets Decreased  1/28 (3.57%)  0/24 (0.00%) 
Thrombocytopenia  11/28 (39.29%)  9/24 (37.50%) 
Cardiac disorders     
Bradycardia  0/28 (0.00%)  1/24 (4.17%) 
Elevated Qtc  1/28 (3.57%)  0/24 (0.00%) 
Low Blood Pressure  1/28 (3.57%)  0/24 (0.00%) 
Vasovagal Syncope  1/28 (3.57%)  0/24 (0.00%) 
Ear and labyrinth disorders     
Imbalance  1/28 (3.57%)  1/24 (4.17%) 
Tinniyus  1/28 (3.57%)  0/24 (0.00%) 
Endocrine disorders     
Hot Flashes  0/28 (0.00%)  1/24 (4.17%) 
Increased Tsh  0/28 (0.00%)  1/24 (4.17%) 
Eye disorders     
Occipital Pain  1/28 (3.57%)  0/24 (0.00%) 
Gastrointestinal disorders     
Altered Taste  2/28 (7.14%)  1/24 (4.17%) 
Anorexia  7/28 (25.00%)  2/24 (8.33%) 
Bloating / Distention  1/28 (3.57%)  0/24 (0.00%) 
Change In Taste  2/28 (7.14%)  0/24 (0.00%) 
Constipation  6/28 (21.43%)  6/24 (25.00%) 
Decreased Appetite  4/28 (14.29%)  4/24 (16.67%) 
Dehydration  1/28 (3.57%)  1/24 (4.17%) 
Diarrhea  14/28 (50.00%)  6/24 (25.00%) 
Dry Mouth  1/28 (3.57%)  2/24 (8.33%) 
Dyspepsia  3/28 (10.71%)  0/24 (0.00%) 
Flatulence  1/28 (3.57%)  1/24 (4.17%) 
Gerd  1/28 (3.57%)  0/24 (0.00%) 
Heartburn  1/28 (3.57%)  2/24 (8.33%) 
Increased Dyspepsia  0/28 (0.00%)  1/24 (4.17%) 
Increased Nausea  1/28 (3.57%)  0/24 (0.00%) 
Loose Stools  1/28 (3.57%)  0/24 (0.00%) 
Loss Of Appetite  1/28 (3.57%)  0/24 (0.00%) 
Metallic Taste  1/28 (3.57%)  0/24 (0.00%) 
Mild Nausea  0/28 (0.00%)  1/24 (4.17%) 
Mucositis- Oral Cavity  1/28 (3.57%)  0/24 (0.00%) 
Nausea  13/28 (46.43%)  9/24 (37.50%) 
Neck Pain  0/28 (0.00%)  1/24 (4.17%) 
Stomach Cramp  2/28 (7.14%)  0/24 (0.00%) 
Taste Changes  3/28 (10.71%)  0/24 (0.00%) 
Tenesmus  0/28 (0.00%)  1/24 (4.17%) 
Vomiting  4/28 (14.29%)  2/24 (8.33%) 
Vomiting (1 Episode)  1/28 (3.57%)  0/24 (0.00%) 
Vomitting, Occasion  1/28 (3.57%)  0/24 (0.00%) 
General disorders     
Back Pain  2/28 (7.14%)  0/24 (0.00%) 
Breast Pain  1/28 (3.57%)  0/24 (0.00%) 
Chills  1/28 (3.57%)  0/24 (0.00%) 
Early Satiety  0/28 (0.00%)  1/24 (4.17%) 
Epigastric Pain  1/28 (3.57%)  0/24 (0.00%) 
Fatigue  14/28 (50.00%)  16/24 (66.67%) 
Flu Like Symptoms  0/28 (0.00%)  1/24 (4.17%) 
Generalized Aches  0/28 (0.00%)  1/24 (4.17%) 
Headache  3/28 (10.71%)  1/24 (4.17%) 
Increased Fatigue  1/28 (3.57%)  0/24 (0.00%) 
Left Jaw Pain  1/28 (3.57%)  0/24 (0.00%) 
Left Sciatic Pain  0/28 (0.00%)  1/24 (4.17%) 
Low Back Pain  0/28 (0.00%)  1/24 (4.17%) 
Nasal Stuffiness  1/28 (3.57%)  0/24 (0.00%) 
Night Sweats  0/28 (0.00%)  1/24 (4.17%) 
Pain  1/28 (3.57%)  1/24 (4.17%) 
Pain, Intermittent  0/28 (0.00%)  1/24 (4.17%) 
Rear Pelvic Left Hip Pain  0/28 (0.00%)  1/24 (4.17%) 
Rib Pain  0/28 (0.00%)  1/24 (4.17%) 
Sacral Pain, Intermittent  0/28 (0.00%)  1/24 (4.17%) 
Severe Fatigue  0/28 (0.00%)  1/24 (4.17%) 
Shoulder Pain  0/28 (0.00%)  1/24 (4.17%) 
Sinus Congestion  1/28 (3.57%)  0/24 (0.00%) 
Sweating  1/28 (3.57%)  0/24 (0.00%) 
Weight Loss  5/28 (17.86%)  2/24 (8.33%) 
Infections and infestations     
Burning, Foul Smelling Urination  0/28 (0.00%)  1/24 (4.17%) 
Dental Abscess  1/28 (3.57%)  1/24 (4.17%) 
Infection- It. Pylori  1/28 (3.57%)  0/24 (0.00%) 
Skin Infection  0/28 (0.00%)  1/24 (4.17%) 
Skin Infection Llq  0/28 (0.00%)  1/24 (4.17%) 
Tooth Infection  1/28 (3.57%)  0/24 (0.00%) 
Upper Respiratory Infection  3/28 (10.71%)  1/24 (4.17%) 
Urinary Tract Infection  1/28 (3.57%)  1/24 (4.17%) 
Injury, poisoning and procedural complications     
Fracture Right Heel  1/28 (3.57%)  0/24 (0.00%) 
L Hip Pain From Fall  0/28 (0.00%)  1/24 (4.17%) 
Metabolism and nutrition disorders     
Albumin  1/28 (3.57%)  0/24 (0.00%) 
Ck Elevated  0/28 (0.00%)  1/24 (4.17%) 
Cpk  1/28 (3.57%)  0/24 (0.00%) 
Creatinine  1/28 (3.57%)  1/24 (4.17%) 
Creatinine Increased  1/28 (3.57%)  0/24 (0.00%) 
Decreased Albumin  1/28 (3.57%)  0/24 (0.00%) 
Decreased Bicarbonates  1/28 (3.57%)  1/24 (4.17%) 
Decreased Cpk  1/28 (3.57%)  0/24 (0.00%) 
Decreased Creatinine  1/28 (3.57%)  0/24 (0.00%) 
Decreased Sodium  1/28 (3.57%)  0/24 (0.00%) 
Elevated Alkaline Phosphatase  0/28 (0.00%)  1/24 (4.17%) 
Elevated Bun  0/28 (0.00%)  1/24 (4.17%) 
Elevated Creatinine  1/28 (3.57%)  2/24 (8.33%) 
Gfr  1/28 (3.57%)  1/24 (4.17%) 
Hypercholesterolemia  1/28 (3.57%)  0/24 (0.00%) 
Hyperglycemia  0/28 (0.00%)  1/24 (4.17%) 
Hyperkalemia  1/28 (3.57%)  1/24 (4.17%) 
Hypermagnesmia  1/28 (3.57%)  1/24 (4.17%) 
Hypertryglyceridemia  1/28 (3.57%)  0/24 (0.00%) 
Hypocalcemia  1/28 (3.57%)  0/24 (0.00%) 
Hypomagnesia  0/28 (0.00%)  1/24 (4.17%) 
Hyponatremia  1/28 (3.57%)  0/24 (0.00%) 
Hypophosphatemia  1/28 (3.57%)  0/24 (0.00%) 
Increased Creatinine  3/28 (10.71%)  2/24 (8.33%) 
Increased Ldh  1/28 (3.57%)  0/24 (0.00%) 
Low Phosphorus  1/28 (3.57%)  0/24 (0.00%) 
Musculoskeletal and connective tissue disorders     
Little Shakey  0/28 (0.00%)  1/24 (4.17%) 
Swelling Leg  0/28 (0.00%)  1/24 (4.17%) 
Ventral Hernia  0/28 (0.00%)  1/24 (4.17%) 
Weakness  1/28 (3.57%)  0/24 (0.00%) 
Nervous system disorders     
Dizziness  6/28 (21.43%)  1/24 (4.17%) 
Light Headed  0/28 (0.00%)  2/24 (8.33%) 
Neuropathy (Bl)  1/28 (3.57%)  0/24 (0.00%) 
Syncope  1/28 (3.57%)  0/24 (0.00%) 
Tremor  0/28 (0.00%)  1/24 (4.17%) 
Psychiatric disorders     
Anxiety  3/28 (10.71%)  1/24 (4.17%) 
Depression  2/28 (7.14%)  2/24 (8.33%) 
Distracted/Concentration Impairment  1/28 (3.57%)  0/24 (0.00%) 
Mood Changes  0/28 (0.00%)  1/24 (4.17%) 
Renal and urinary disorders     
Bladder Outlet Obstruction  1/28 (3.57%)  0/24 (0.00%) 
Hematuria  3/28 (10.71%)  1/24 (4.17%) 
Nocturia  0/28 (0.00%)  1/24 (4.17%) 
Urinary Frequency  1/28 (3.57%)  2/24 (8.33%) 
Urinary Incontinence (Bl)  1/28 (3.57%)  0/24 (0.00%) 
Urinary Retention  1/28 (3.57%)  0/24 (0.00%) 
Reproductive system and breast disorders     
Breast Enlargement  0/28 (0.00%)  1/24 (4.17%) 
Respiratory, thoracic and mediastinal disorders     
Bronchial Obstruction  1/28 (3.57%)  0/24 (0.00%) 
Chest Pressure  0/28 (0.00%)  1/24 (4.17%) 
Dry Cough  0/28 (0.00%)  1/24 (4.17%) 
Dyspnea  1/28 (3.57%)  0/24 (0.00%) 
Shortness Of Breath  0/28 (0.00%)  1/24 (4.17%) 
Skin and subcutaneous tissue disorders     
Alopecia  0/28 (0.00%)  1/24 (4.17%) 
Blotches  0/28 (0.00%)  1/24 (4.17%) 
Cold Sore  0/28 (0.00%)  1/24 (4.17%) 
Facial Erythematous  1/28 (3.57%)  0/24 (0.00%) 
Hair Loss  0/28 (0.00%)  1/24 (4.17%) 
Hematoma  0/28 (0.00%)  1/24 (4.17%) 
Nail Changes  1/28 (3.57%)  1/24 (4.17%) 
R Upper Chest Anular Erythema  1/28 (3.57%)  0/24 (0.00%) 
Rash  0/28 (0.00%)  1/24 (4.17%) 
Right Flank Bruise  1/28 (3.57%)  0/24 (0.00%) 
Skin Dermatitis  1/28 (3.57%)  0/24 (0.00%) 
Weak Finger Nails  0/28 (0.00%)  1/24 (4.17%) 
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
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