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Efficacy and Safety Study of Etodolac and Propranolol in Patients With Clinically Progressive Prostate Cancer

Information source: Vicus Therapeutics
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Prostatic Neoplasms

Intervention: VT-122 (Drug); Placebo (Drug)

Phase: Phase 2

Status: Recruiting

Sponsored by: Vicus Therapeutics

Overall contact:
Simmon Pornillos, Phone: 289-772-6103, Email: simmonp@axiommetrics.com

Summary

The purpose of this study is to evaluate the clinical benefit of the co-administration of propranolol and etodolac (VT-122 therapy) in patients with clinically progressive prostate cancer.

Clinical Details

Official title: A Randomized, Placebo Controlled, Multicenter Phase 2 Study of Etodolac and Propranolol in Patients With Clinically Progressive Prostate Cancer

Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Change in prostate specific antigen (PSA)

Secondary outcome:

PSA progression

PSA doubling time (PSADT)

Change in self-reported performance (EQ-5D), pain (visual analog scale [VAS] and opiate usage)

Time to symptom progression (TTSP)

Change in correlative biomarkers

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Male.

Criteria:

Inclusion Criteria: 1. Have a confirmed diagnosis of prostate cancer 2. Male participants who are ≥18 years of age 3. In the opinion of the investigator, the participants have a life expectancy of at least 3 months. 4. Two consecutively rising PSA values or two out of three rising PSA values (2. 0 ng/mL is the minimum ending value for PSA) at a minimum of 1-week intervals 5. Have a Karnofsky Performance Score (KPS) equal to or greater than 70 6. Have the following laboratory parameters (may be assessed locally): 1. Platelet count ≥50 x 10E3/µL 2. Total bilirubin ≤1. 5 mg/dL 3. Serum creatinine ≤1. 5 x upper limit of normal (ULN) or creatinine clearance >60 mL/min calculated using Cockcroft-Gault 4. Liver enzymes [aspartate transaminase (AST), alanine transaminase (ALT)] ≤2 x ULN 7. Able to provide written informed consent prior to any study specific screening procedures with the understanding that the patient has the right to withdraw from the study at any time, for any reason without prejudice Exclusion Criteria: 1. The patient has a history of another primary cancer, with the exception of: 1. Curatively resected non-melanomatous skin cancer; 2. Other primary solid tumor with no known active disease presents that in the opinion of the investigator that will not affect patient outcome in the setting of current prostate cancer diagnosis. 2. Contraindication to propranolol, etodolac 3. Patients on beta blockers 4. Patients receiving chemotherapy (e. g., docetaxel, cabazitaxel, taxane, or platinum as single agents or in combination) as their cancer treatment 5. History or evidence of cardiac disease: congestive heart failure; New York Heart Association class 2 or greater; active coronary artery disease; unstable angina, cardiac arrhythmias requiring anti-arrhythmic therapy, atrio-ventricular block of second or third degree, or uncontrolled hypertension, patients with recent (less than 6 months) myocardial infarction (MI) or coronary revascularization 6. Hypotension at the time of screening (i. e., systolic blood pressure less than 110 mmHg. Diastolic blood pressure less than 60 mmHg) 7. Resting heart rate less than 60 bpm at time of screening 8. Any uncontrolled, intercurrent illness that in the opinion of the Investigator may interfere with study evaluation. Participants with uncontrolled diabetes will be excluded from the study. 9. On chronotropic drugs (acetylcholine, digoxin, diltiazem, verapamil, atropine, dopamine, dobutamine, epinephrine, isoproterenol) 10. Active clinically serious infections [> Grade 2 National Cancer Institute (NCI)-Common Terminology Criteria for Adverse Events (CTCAE) version 4. 0] 11. Substance abuse, medical, psychological or social conditions that may, in the opinion of the investigator, interfere with the patient's participation in the study or evaluation of the study results 12. Known or suspected allergy to the investigational agents or any agent given in association with this trial (hypersensitivity reaction, hives, rash, difficulty breathing swelling of your face, lips, tongue, or throat) 13. Any condition that is unstable or which in the opinion of the Investigator could jeopardize the safety of the patient and his/her compliance in the study 14. Patients with uncontrolled diabetes or insulin resistance 15. Participation in any other investigational trial in which receipt of investigational drug or device occurred within 30 days prior to screening for this study

Locations and Contacts

Simmon Pornillos, Phone: 289-772-6103, Email: simmonp@axiommetrics.com

Homewood, Alabama 35209, United States; Withdrawn

Anchorage, Alaska 99503, United States; Withdrawn

Fayetteville, Arkansas 72703, United States; Recruiting
Simmon Pornillos, Phone: 289-772-6103, Email: simmonp@axiommetrics.com

Santa Rosa, California 95403, United States; Recruiting
Simmon Pornillos, Phone: 289-772-6103, Email: simmonp@axiommetrics.com

Parker, Colorado 80134, United States; Recruiting
Simmon Pornillos, Phone: 289-772-6103, Email: simmonp@axiommetrics.com

Bradenton, Florida 34205, United States; Recruiting
Simmon Pornillos, Phone: 289-772-6103, Email: simmonp@axiommetrics.com

Jacksonville, Florida 32207, United States; Recruiting
Simmon Pornillos, Phone: 289-772-6103, Email: simmonp@axiommetrics.com

Zion, Illinois 60099, United States; Recruiting
Simmon Pornillos, Phone: 289-772-6103, Email: simmonp@axiommetrics.com

Greenbelt, Maryland 20770, United States; Withdrawn

Detroit, Michigan 48201, United States; Recruiting
Simmon Pornillos, Phone: 289-772-6103, Email: simmonp@axiommetrics.com

Lansing, Michigan 48912, United States; Recruiting
Simmon Pornillos, Phone: 289-772-6103, Email: simmonp@axiommetrics.com

Troy, Michigan 48084, United States; Withdrawn

Sartell, Minnesota 56377, United States; Recruiting
Simmon Pornillos, Phone: 289-772-6103, Email: simmonp@axiommetrics.com

Jersey City, New Jersey 07306, United States; Withdrawn

Bronx, New York 10467, United States; Recruiting
Simmon Pornillos, Phone: 289-772-6103, Email: simmonp@axiommetrics.com

Garden City, New York 11530, United States; Recruiting
Simmon Pornillos, Phone: 289-772-6103, Email: simmonp@axiommetrics.com

Poughkeepsie, New York 12601, United States; Recruiting
Simmon Pornillos, Phone: 289-772-6103, Email: simmonp@axiommetrics.com

Cincinnati, Ohio 45212, United States; Withdrawn

Gettysburg, Pennsylvania 17325, United States; Withdrawn

Abilene, Texas 79601, United States; Recruiting
Simmon Pornillos, Phone: 289-772-6103, Email: simmonp@axiommetrics.com

Houston, Texas 77030, United States; Recruiting
Simmon Pornillos, Phone: 289-772-6103, Email: simmonp@axiommetrics.com

Houston, Texas 77030, United States; Withdrawn

Seattle, Washington 98101, United States; Recruiting
Simmon Pornillos, Phone: 289-772-6103, Email: simmonp@axiommetrics.com

Spokane, Washington 99208, United States; Recruiting
Simmon Pornillos, Phone: 289-772-6103, Email: simmonp@axiommetrics.com

Additional Information

Starting date: June 2013
Last updated: October 18, 2014

Page last updated: August 23, 2015

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