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

• Sponsor: NYU Langone Health (Other)
• Overall Status: Completed
• CT.gov ID: NCT00878436
• Collaborator: Novartis (Industry)
• Enrollment: 52
• Locations: 4
• Arms: 2
• Duration (Months): 73
• Patients Per Site: 13
• Patients Per Site Per Month: 0.2

Study Details

Study Description

Brief Summary

This trial is designed to investigate the safety, dosing schedule, and efficacy of the combination treatment of Panobinostat (a histone deacetylase inhibitor) and hormone therapy for recurrent prostate cancer. This trial is at its Phase II stage. As of July 23, 2013 Arm B was closed to accrual, all the remaining slots in accrual will be allocated to Arm A.

Condition or Disease	Intervention/Treatment	Phase
Prostate Cancer; Prostatic Neoplasms	Drug: Panobinostat; Drug: Bicalutamide	Phase 1/Phase 2

Detailed Description

The preclinical data indicate that Panobinostat restores the sensitivity of androgen-independent cells to bicalutamide (Casodex®) and the combination has synergistic inhibitory activity. Here, we hypothesize that treatment of castration-resistant patients with Panobinostat will enhance the response to the second line hormone therapy with bicalutamide (Casodex®). In the proposed phase I study, the maximum tolerated dose of tri-weekly, intermittent oral Panobinostat at three different dose levels (60, 90, 120 mg/week) in combination with Casodex (50mg PO) will be determined; The following phase II study will evaluated the efficacies of 9-month treatments of the selected Panobinostat-Casodex combination and also a lower dose of Panobinostat. We expect that Casodex-Panobinostat combination treatment of castration-resistant patients will prevent biochemical and/or metastatic disease progression of these patients compared to historical controls in the same time period.

Study Design

• Study Type: Interventional
• Actual Enrollment: 52 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Phase I/II Randomized Trial of LBH589 (Panobinostat) at Two Dose Levels Combined With Bicalutamide (Casodex) in Men With Castration-resistant Prostate Cancer
• Study Start Date: Jun 1, 2009
• Actual Primary Completion Date: Mar 1, 2015
• Actual Study Completion Date: Jul 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Arm A (120 mg/week) Each treatment cycle has 21 days: Bicalutamide (Casodex®) 50mg P.O. daily, continuously, with the addition of: 40 mg Panobinostat 3 times per week (120 mg per week) for 2 consecutive weeks with one week rest	Drug: Panobinostat; Other Names: LBH589 ; Drug: Bicalutamide; Other Names: Casodex
Experimental: Arm B (60 mg/week)-Closed to accrual Each treatment cycle has 21 days: Bicalutamide (Casodex®) 50mg P.O. daily, continuously, with the addition of: 20 mg Panobinostat 3 times per week (60 mg per week) for 2 consecutive weeks with one week rest	Drug: Panobinostat; Other Names: LBH589 ; Drug: Bicalutamide; Other Names: Casodex

Outcome Measures

Primary Outcome Measures

1. Percentage of Patients Free of Progression and Without Symptomatic Deterioration [9 months]

   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.

2. Percentage of Patients Free of Progression and Without Symptomatic Deterioration [6 months]

   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.

Secondary Outcome Measures

1. Time to PSA Progression [up to 2 years]

   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

2. Number of Patients That Achieve a 50% or Greater PSA Decline by 9 Months of Therapy [9 months]

   Unable to locate PI for secondary outcome measure results. Data is not available.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Male patients aged ≥ 18 years old

• Ability to provide written informed consent obtained prior to participation in the study and any related procedures being performed

• Patients must meet laboratory criteria

• Baseline MUGA or ECHO must demonstrate LVEF ≥ the lower limit of the institutional normal.

• ECOG Performance Status of ≤ 2

• Documented history of adenocarcinoma of the prostate.

• Patients must have evidence of disease progression while receiving androgen suppression therapy by orchiectomy or other primary hormonal therapy including, but not limited to (LHRH agonist therapy (e.g., leuprolide or goserelin) or LHRH antagonist (e.g. aberelix). Note: patients who have not undergone bilateral orchiectomy must continue LHRH therapy while on protocol

• Testosterone must be < 50 ng/dl confirmed within 4 weeks prior to registration for patients on LHRH therapy

• Patients must have evidence of disease progression with either one or both of the conditions listed:

• Biochemical progression only

• Metastases on bone scan

• Patients may have received one chemotherapy, investigational agent or immunotherapy in the neoadjuvant, adjuvant setting or during initial LHRH therapy with new evidence of disease progression after discontinuation of therapy for ≥ 2 weeks.

• Patients must have received one or more prior second line hormone therapy for progression while on LHRH treatment or orchiectomy.

• Patients treated with one first line chemotherapy combination for hormone refractory progression ≥ 4 weeks prior to registration who have evidence of disease progression and had only one second line hormone therapy and did not experience PSA response to bicalutamide (Casodex®) withdrawal.

Exclusion Criteria:

• Prior treatment with an HDAC inhibitor

• Impaired cardiac function including any one of the following:

• Screening ECG with a QTc > 450 msec confirmed by central laboratory prior to enrollment to the study

• Patients with congenital long QT syndrome

• History of sustained ventricular tachycardia

• Any history of ventricular fibrillation or torsades de pointes

• Bradycardia defined as heart rate < 50 beats per minute. Patients with a pacemaker and heart rate ≥ 50 beats per minute are eligible.

• Patients with a myocardial infarction or unstable angina within 6 months of study entry

• Congestive heart failure (NY Heart Association class III or IV)

• Right bundle branch block in conjunction with left anterior hemi-block (bifasicular block)

• Uncontrolled hypertension

• Concomitant use of drugs with a risk of causing torsades de pointes

• Concomitant use of CYP3A4 inhibitors

• Patients with unresolved diarrhea greater than CTCAE grade 1

• Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of oral LBH589

• Other concurrent severe and/or uncontrolled medical conditions

• Patients who have received chemotherapy, any investigational drug or undergone major surgery < 4 weeks prior to starting study drug or who have not recovered from side effects of such therapy.

• Concomitant use of any anti-cancer therapy or radiation therapy.

• Male patients whose sexual partners are WOCBP not using effective birth control

• Patients with a history of another primary malignancy within the last 2 years that was not curatively treated, excluding basal or squamous cell carcinoma of the skin

• Patients with known positivity for human immunodeficiency virus (HIV) or hepatitis C; baseline testing for HIV and hepatitis C is not required

• Patients with any significant history of non-compliance to medical regimens or with inability to grant a reliable informed consent

• Patients previously treated with bicalutamide (Casodex®) who experienced a PSA withdrawal response in the washout period as described in Inclusion #11 will not be eligible

• Concurrent use of estrogens or estrogen like substances (i.e. PC-SPES, Saw Palmetto, or other herbal product which may contain phytoestrogens) is not allowed. Prior use of these agents will need to be discontinued at least 4 weeks prior to enrollment, for the above.

• Radiotherapy within the 4 weeks prior to registration

• Inadequate bone marrow function measured 28 days prior to registration

• No serious concurrent medical illness or active infection that would jeopardize the ability of the patient to receive therapy as outlined in the protocol with reasonable safety.

• Liver metastasis.

• The use of bisphosphonates in the absence of metastasis will not be allowed. Patients on bisphosphonates for more than 4 weeks for asymptomatic bone metastasis and with continued evidence of PSA progression may continue on bisphosphonates every 4 weeks.

• Hydronephrosis with impaired renal function.

• Active spinal cord compression.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The Cancer Institute of New Jersey	New Brunswick	New Jersey	United States	08903
2	North Shore University Hospital-Monter Cancer Center	Lake Success	New York	United States	11042
3	NYU Cancer Center	New York	New York	United States	10016
4	Oregon Health & Science University	Portland	Oregon	United States	97239

Sponsors and Collaborators

• NYU Langone Health
• Novartis

Investigators

• Principal Investigator: Anna Ferrari, MD, NYU Langone Health

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: NYU Langone Health
• ClinicalTrials.gov Identifier: NCT00878436
• Other Study ID Numbers: 08-479
• First Posted: Apr 9, 2009
• Last Update Posted: Feb 7, 2018
• Last Verified: Jan 1, 2018

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by NYU Langone Health: histone deacetylase inhibitor; hormone therapy; androgen-independent; PSA; androgen receptor
• Additional relevant MeSH terms: Prostatic Neoplasms; Bicalutamide; Panobinostat

Study Results

Participant Flow

Recruitment Details	Members of the research team have attempted to contact the PI, unsuccessfully, and are unable to answer questions regarding results.

Arm/Group Title	LBH 40mg	LBH 20mg
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

Baseline Characteristics

Arm/Group Title	LBH 40mg	LBH 20mg	Total
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 Participants	28	24	52
Age (years) [Median (Full Range) ]
Median (Full Range) [years]	69	69	69
Sex: Female, Male (Count of Participants)
Female	0 0%	0 0%	0 0%
Male	28 100%	24 100%	52 100%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	0 0%	1 4.2%	1 1.9%
Native Hawaiian or Other Pacific Islander	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%
Unknown or Not Reported	0 0%	0 0%	0 0%

Outcome Measures

1. Primary Outcome

Title	Percentage of Patients Free of Progression and Without Symptomatic Deterioration
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	LBH 40mg	LBH 20mg
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.
Measure Participants	21	20
Number [percentage of Participants]	24 85.7%	9 37.5%

2. Primary Outcome

Title	Percentage of Patients Free of Progression and Without Symptomatic Deterioration
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	LBH 40mg	LBH 20mg
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.
Measure Participants	21	20
Number [percentage of participants]	42 150%	19 79.2%

3. Secondary Outcome

Title	Time to PSA Progression
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

Outcome Measure Data

Analysis Population Description

Unable to locate PI for secondary outcome measure results. Data is not available.

Arm/Group Title	LBH 40mg	LBH 20mg
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.
Measure Participants	0	0

4. Secondary Outcome

Title	Number of Patients That Achieve a 50% or Greater PSA Decline by 9 Months of Therapy
Description	Unable to locate PI for secondary outcome measure results. Data is not available.
Time Frame	9 months

Outcome Measure Data

Analysis Population Description

Unable to locate PI for secondary outcome measure results. Data is not available.

Arm/Group Title	LBH 40mg	LBH 20mg
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.
Measure Participants	0	0

Adverse Events

Arm/Group Title	LBH 40mg		LBH 20mg
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 (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	LBH 40mg		LBH 20mg
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	11/28 (39.3%)		5/24 (20.8%)
Blood and lymphatic system disorders
Myelodysplasia	0/28 (0%)		1/24 (4.2%)
Pancytopenia	0/28 (0%)		1/24 (4.2%)
Subarachoid Hemorrhage	0/28 (0%)		1/24 (4.2%)
Subdural Hematoma	0/28 (0%)		1/24 (4.2%)
Thrombocytopenia	5/28 (17.9%)		0/24 (0%)
Cardiac disorders
Cardiac Asystole	0/28 (0%)		1/24 (4.2%)
Qtc Prolonged	1/28 (3.6%)		0/24 (0%)
Gastrointestinal disorders
Dehydration	1/28 (3.6%)		2/24 (8.3%)
Diarrhea	1/28 (3.6%)		0/24 (0%)
Nausea	1/28 (3.6%)		0/24 (0%)
Stomach Pain	1/28 (3.6%)		0/24 (0%)
Ulcers	1/28 (3.6%)		0/24 (0%)
Vomiting	2/28 (7.1%)		0/24 (0%)
General disorders
Chest Pain	1/28 (3.6%)		0/24 (0%)
Fatigue	1/28 (3.6%)		0/24 (0%)
Fever	1/28 (3.6%)		0/24 (0%)
Karposi Sarcoma	0/28 (0%)		1/24 (4.2%)
Metabolism and nutrition disorders
Hyperglycemia	1/28 (3.6%)		0/24 (0%)
Hypokalemia	0/28 (0%)		1/24 (4.2%)
Nervous system disorders
Dizziness	0/28 (0%)		1/24 (4.2%)
Syncope	3/28 (10.7%)		1/24 (4.2%)
Renal and urinary disorders
Acute Renal Failure	1/28 (3.6%)		0/24 (0%)
Surgical and medical procedures
Cord Compression	1/28 (3.6%)		0/24 (0%)
Pleural Effusion	0/28 (0%)		1/24 (4.2%)
Other (Not Including Serious) Adverse Events
	LBH 40mg		LBH 20mg
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	26/28 (92.9%)		24/24 (100%)
Blood and lymphatic system disorders
Anc	0/28 (0%)		1/24 (4.2%)
Anemia	3/28 (10.7%)		3/24 (12.5%)
Bilateral Lower Extremity Edema	1/28 (3.6%)		0/24 (0%)
Bruising	1/28 (3.6%)		0/24 (0%)
Decreased Platelets	1/28 (3.6%)		0/24 (0%)
Edema- Leg	1/28 (3.6%)		0/24 (0%)
Edema- Pedal	1/28 (3.6%)		0/24 (0%)
Enlarged L Neck Node (Bl)	1/28 (3.6%)		0/24 (0%)
L Eye Conjunctival Hemorrhage	1/28 (3.6%)		0/24 (0%)
Left Scleral Hemorrhage	1/28 (3.6%)		0/24 (0%)
Leg Edema	1/28 (3.6%)		0/24 (0%)
Leukopenia	1/28 (3.6%)		0/24 (0%)
Low Platelets	1/28 (3.6%)		0/24 (0%)
Lower Extremity Edema	1/28 (3.6%)		0/24 (0%)
Neutropenia	5/28 (17.9%)		0/24 (0%)
Nose Bleeds	1/28 (3.6%)		0/24 (0%)
Petechial Rash (Arms & Legs)	1/28 (3.6%)		0/24 (0%)
Platelets	1/28 (3.6%)		0/24 (0%)
Platelets Decreased	1/28 (3.6%)		0/24 (0%)
Thrombocytopenia	11/28 (39.3%)		9/24 (37.5%)
Cardiac disorders
Bradycardia	0/28 (0%)		1/24 (4.2%)
Elevated Qtc	1/28 (3.6%)		0/24 (0%)
Low Blood Pressure	1/28 (3.6%)		0/24 (0%)
Vasovagal Syncope	1/28 (3.6%)		0/24 (0%)
Ear and labyrinth disorders
Imbalance	1/28 (3.6%)		1/24 (4.2%)
Tinniyus	1/28 (3.6%)		0/24 (0%)
Endocrine disorders
Hot Flashes	0/28 (0%)		1/24 (4.2%)
Increased Tsh	0/28 (0%)		1/24 (4.2%)
Eye disorders
Occipital Pain	1/28 (3.6%)		0/24 (0%)
Gastrointestinal disorders
Altered Taste	2/28 (7.1%)		1/24 (4.2%)
Anorexia	7/28 (25%)		2/24 (8.3%)
Bloating / Distention	1/28 (3.6%)		0/24 (0%)
Change In Taste	2/28 (7.1%)		0/24 (0%)
Constipation	6/28 (21.4%)		6/24 (25%)
Decreased Appetite	4/28 (14.3%)		4/24 (16.7%)
Dehydration	1/28 (3.6%)		1/24 (4.2%)
Diarrhea	14/28 (50%)		6/24 (25%)
Dry Mouth	1/28 (3.6%)		2/24 (8.3%)
Dyspepsia	3/28 (10.7%)		0/24 (0%)
Flatulence	1/28 (3.6%)		1/24 (4.2%)
Gerd	1/28 (3.6%)		0/24 (0%)
Heartburn	1/28 (3.6%)		2/24 (8.3%)
Increased Dyspepsia	0/28 (0%)		1/24 (4.2%)
Increased Nausea	1/28 (3.6%)		0/24 (0%)
Loose Stools	1/28 (3.6%)		0/24 (0%)
Loss Of Appetite	1/28 (3.6%)		0/24 (0%)
Metallic Taste	1/28 (3.6%)		0/24 (0%)
Mild Nausea	0/28 (0%)		1/24 (4.2%)
Mucositis- Oral Cavity	1/28 (3.6%)		0/24 (0%)
Nausea	13/28 (46.4%)		9/24 (37.5%)
Neck Pain	0/28 (0%)		1/24 (4.2%)
Stomach Cramp	2/28 (7.1%)		0/24 (0%)
Taste Changes	3/28 (10.7%)		0/24 (0%)
Tenesmus	0/28 (0%)		1/24 (4.2%)
Vomiting	4/28 (14.3%)		2/24 (8.3%)
Vomiting (1 Episode)	1/28 (3.6%)		0/24 (0%)
Vomitting, Occasion	1/28 (3.6%)		0/24 (0%)
General disorders
Back Pain	2/28 (7.1%)		0/24 (0%)
Breast Pain	1/28 (3.6%)		0/24 (0%)
Chills	1/28 (3.6%)		0/24 (0%)
Early Satiety	0/28 (0%)		1/24 (4.2%)
Epigastric Pain	1/28 (3.6%)		0/24 (0%)
Fatigue	14/28 (50%)		16/24 (66.7%)
Flu Like Symptoms	0/28 (0%)		1/24 (4.2%)
Generalized Aches	0/28 (0%)		1/24 (4.2%)
Headache	3/28 (10.7%)		1/24 (4.2%)
Increased Fatigue	1/28 (3.6%)		0/24 (0%)
Left Jaw Pain	1/28 (3.6%)		0/24 (0%)
Left Sciatic Pain	0/28 (0%)		1/24 (4.2%)
Low Back Pain	0/28 (0%)		1/24 (4.2%)
Nasal Stuffiness	1/28 (3.6%)		0/24 (0%)
Night Sweats	0/28 (0%)		1/24 (4.2%)
Pain	1/28 (3.6%)		1/24 (4.2%)
Pain, Intermittent	0/28 (0%)		1/24 (4.2%)
Rear Pelvic Left Hip Pain	0/28 (0%)		1/24 (4.2%)
Rib Pain	0/28 (0%)		1/24 (4.2%)
Sacral Pain, Intermittent	0/28 (0%)		1/24 (4.2%)
Severe Fatigue	0/28 (0%)		1/24 (4.2%)
Shoulder Pain	0/28 (0%)		1/24 (4.2%)
Sinus Congestion	1/28 (3.6%)		0/24 (0%)
Sweating	1/28 (3.6%)		0/24 (0%)
Weight Loss	5/28 (17.9%)		2/24 (8.3%)
Infections and infestations
Burning, Foul Smelling Urination	0/28 (0%)		1/24 (4.2%)
Dental Abscess	1/28 (3.6%)		1/24 (4.2%)
Infection- It. Pylori	1/28 (3.6%)		0/24 (0%)
Skin Infection	0/28 (0%)		1/24 (4.2%)
Skin Infection Llq	0/28 (0%)		1/24 (4.2%)
Tooth Infection	1/28 (3.6%)		0/24 (0%)
Upper Respiratory Infection	3/28 (10.7%)		1/24 (4.2%)
Urinary Tract Infection	1/28 (3.6%)		1/24 (4.2%)
Injury, poisoning and procedural complications
Fracture Right Heel	1/28 (3.6%)		0/24 (0%)
L Hip Pain From Fall	0/28 (0%)		1/24 (4.2%)
Metabolism and nutrition disorders
Albumin	1/28 (3.6%)		0/24 (0%)
Ck Elevated	0/28 (0%)		1/24 (4.2%)
Cpk	1/28 (3.6%)		0/24 (0%)
Creatinine	1/28 (3.6%)		1/24 (4.2%)
Creatinine Increased	1/28 (3.6%)		0/24 (0%)
Decreased Albumin	1/28 (3.6%)		0/24 (0%)
Decreased Bicarbonates	1/28 (3.6%)		1/24 (4.2%)
Decreased Cpk	1/28 (3.6%)		0/24 (0%)
Decreased Creatinine	1/28 (3.6%)		0/24 (0%)
Decreased Sodium	1/28 (3.6%)		0/24 (0%)
Elevated Alkaline Phosphatase	0/28 (0%)		1/24 (4.2%)
Elevated Bun	0/28 (0%)		1/24 (4.2%)
Elevated Creatinine	1/28 (3.6%)		2/24 (8.3%)
Gfr	1/28 (3.6%)		1/24 (4.2%)
Hypercholesterolemia	1/28 (3.6%)		0/24 (0%)
Hyperglycemia	0/28 (0%)		1/24 (4.2%)
Hyperkalemia	1/28 (3.6%)		1/24 (4.2%)
Hypermagnesmia	1/28 (3.6%)		1/24 (4.2%)
Hypertryglyceridemia	1/28 (3.6%)		0/24 (0%)
Hypocalcemia	1/28 (3.6%)		0/24 (0%)
Hypomagnesia	0/28 (0%)		1/24 (4.2%)
Hyponatremia	1/28 (3.6%)		0/24 (0%)
Hypophosphatemia	1/28 (3.6%)		0/24 (0%)
Increased Creatinine	3/28 (10.7%)		2/24 (8.3%)
Increased Ldh	1/28 (3.6%)		0/24 (0%)
Low Phosphorus	1/28 (3.6%)		0/24 (0%)
Musculoskeletal and connective tissue disorders
Little Shakey	0/28 (0%)		1/24 (4.2%)
Swelling Leg	0/28 (0%)		1/24 (4.2%)
Ventral Hernia	0/28 (0%)		1/24 (4.2%)
Weakness	1/28 (3.6%)		0/24 (0%)
Nervous system disorders
Dizziness	6/28 (21.4%)		1/24 (4.2%)
Light Headed	0/28 (0%)		2/24 (8.3%)
Neuropathy (Bl)	1/28 (3.6%)		0/24 (0%)
Syncope	1/28 (3.6%)		0/24 (0%)
Tremor	0/28 (0%)		1/24 (4.2%)
Psychiatric disorders
Anxiety	3/28 (10.7%)		1/24 (4.2%)
Depression	2/28 (7.1%)		2/24 (8.3%)
Distracted/Concentration Impairment	1/28 (3.6%)		0/24 (0%)
Mood Changes	0/28 (0%)		1/24 (4.2%)
Renal and urinary disorders
Bladder Outlet Obstruction	1/28 (3.6%)		0/24 (0%)
Hematuria	3/28 (10.7%)		1/24 (4.2%)
Nocturia	0/28 (0%)		1/24 (4.2%)
Urinary Frequency	1/28 (3.6%)		2/24 (8.3%)
Urinary Incontinence (Bl)	1/28 (3.6%)		0/24 (0%)
Urinary Retention	1/28 (3.6%)		0/24 (0%)
Reproductive system and breast disorders
Breast Enlargement	0/28 (0%)		1/24 (4.2%)
Respiratory, thoracic and mediastinal disorders
Bronchial Obstruction	1/28 (3.6%)		0/24 (0%)
Chest Pressure	0/28 (0%)		1/24 (4.2%)
Dry Cough	0/28 (0%)		1/24 (4.2%)
Dyspnea	1/28 (3.6%)		0/24 (0%)
Shortness Of Breath	0/28 (0%)		1/24 (4.2%)
Skin and subcutaneous tissue disorders
Alopecia	0/28 (0%)		1/24 (4.2%)
Blotches	0/28 (0%)		1/24 (4.2%)
Cold Sore	0/28 (0%)		1/24 (4.2%)
Facial Erythematous	1/28 (3.6%)		0/24 (0%)
Hair Loss	0/28 (0%)		1/24 (4.2%)
Hematoma	0/28 (0%)		1/24 (4.2%)
Nail Changes	1/28 (3.6%)		1/24 (4.2%)
R Upper Chest Anular Erythema	1/28 (3.6%)		0/24 (0%)
Rash	0/28 (0%)		1/24 (4.2%)
Right Flank Bruise	1/28 (3.6%)		0/24 (0%)
Skin Dermatitis	1/28 (3.6%)		0/24 (0%)
Weak Finger Nails	0/28 (0%)		1/24 (4.2%)

Limitations/Caveats

[Not Specified]

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.