- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01857817
Efficacy and Safety Study of Etodolac and Propranolol in Patients With Clinically Progressive Prostate Cancer
April 24, 2018 updated by: Vicus Therapeutics
A Randomized, Placebo Controlled, Multicenter Phase 2 Study of Etodolac and Propranolol in Patients With Clinically Progressive Prostate Cancer
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.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
35
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Arkansas
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Fayetteville, Arkansas, United States, 72703
- Highlands Oncology Group
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California
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Santa Rosa, California, United States, 95403
- Redwood Regional Medical Group
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Colorado
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Parker, Colorado, United States, 80134
- Advanced Urology
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Florida
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Bradenton, Florida, United States, 34205
- Manatee Medical Research Institute, LLC
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Jacksonville, Florida, United States, 32207
- Baptist Cancer Institute
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Illinois
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Zion, Illinois, United States, 60099
- Midwestern Regional Medical Center
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Michigan
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Detroit, Michigan, United States, 48201
- Karmanos Cancer Institute
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Lansing, Michigan, United States, 48912
- Detroit Clinical Research Center, PC
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Minnesota
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Sartell, Minnesota, United States, 56377
- Adult & Pediatric Urology
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New York
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Bronx, New York, United States, 10467
- Montefiore Medical Center
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Garden City, New York, United States, 11530
- AccuMed Research Associates
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Poughkeepsie, New York, United States, 12601
- Premier Medical Group of the Hudson Valley PC
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Texas
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Abilene, Texas, United States, 79601
- Hendrick Cancer Center
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Houston, Texas, United States, 77030
- Oncology Consultants, P.A.
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Washington
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Seattle, Washington, United States, 98101
- Virginia Mason Medical Center
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Spokane, Washington, United States, 99208
- Medical Oncology Associates, PS
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- Have a confirmed diagnosis of prostate cancer
- Male participants who are ≥18 years of age
- In the opinion of the investigator, the participants have a life expectancy of at least 3 months.
- 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
- Have a Karnofsky Performance Score (KPS) equal to or greater than 70
Have the following laboratory parameters (may be assessed locally):
- Platelet count ≥50 x 10E3/µL
- Total bilirubin ≤1.5 mg/dL
- Serum creatinine ≤1.5 x upper limit of normal (ULN) or creatinine clearance >60 mL/min calculated using Cockcroft-Gault
- Liver enzymes [aspartate transaminase (AST), alanine transaminase (ALT)] ≤2 x ULN
- 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:
The patient has a history of another primary cancer, with the exception of:
- Curatively resected non-melanomatous skin cancer;
- 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.
- Contraindication to propranolol, etodolac
- Patients on beta blockers
- Patients receiving chemotherapy (e.g., docetaxel, cabazitaxel, taxane, or platinum as single agents or in combination) as their cancer treatment
- 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
- Hypotension at the time of screening (i.e., systolic blood pressure less than 110 mmHg. Diastolic blood pressure less than 60 mmHg)
- Resting heart rate less than 60 bpm at time of screening
- 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.
- On chronotropic drugs (acetylcholine, digoxin, diltiazem, verapamil, atropine, dopamine, dobutamine, epinephrine, isoproterenol)
- Active clinically serious infections [> Grade 2 National Cancer Institute (NCI)-Common Terminology Criteria for Adverse Events (CTCAE) version 4.0]
- 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
- 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)
- 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
- Patients with uncontrolled diabetes or insulin resistance
- Participation in any other investigational trial in which receipt of investigational drug or device occurred within 30 days prior to screening for this study
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: VT-122 with physician's choice therapy
Participants will receive oral doses of 66 mg propranolol and 680 mg etodolac daily.
Propranolol will be administered 44 mg with breakfast and 22 mg in the mid-afternoon (3PM).
Etodolac will be administered 340 mg with breakfast and 340 mg with dinner.
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The following will be used in the study for VT-122: propranolol 22 mg immediate-release capsules and etodolac 340 mg capsules.
Other Names:
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Placebo Comparator: Placebo with physician's choice therapy
Participants will receive physician's choice therapy as the standard of care as well as the placebo capsules that are of the same weight as propranolol and etodolac.
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The placebo capsules will be prepared to match the active drug.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in prostate specific antigen (PSA)
Time Frame: baseline (Day 1 Cycle 1) to 12 weeks (Day 1, Cycle 4)
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baseline (Day 1 Cycle 1) to 12 weeks (Day 1, Cycle 4)
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
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PSA progression
Time Frame: baseline to 12 weeks
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baseline to 12 weeks
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PSA doubling time (PSADT)
Time Frame: baseline and every month during treatment
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baseline and every month during treatment
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Change in self-reported performance (EQ-5D), pain (visual analog scale [VAS] and opiate usage)
Time Frame: Day 1 Cycle 1, on Day 1 of each subsequent 28-day cycle, and on end of treatment
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Day 1 Cycle 1, on Day 1 of each subsequent 28-day cycle, and on end of treatment
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Time to symptom progression (TTSP)
Time Frame: Day 1 Cycle 1 and Day 1 of each subsequent 28-day cycle
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Day 1 Cycle 1 and Day 1 of each subsequent 28-day cycle
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Change in correlative biomarkers
Time Frame: Day 1 Cycle 1, on Day 1 of each subsequent 28-day cycle, and on end of treatment
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Day 1 Cycle 1, on Day 1 of each subsequent 28-day cycle, and on end of treatment
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2013
Primary Completion (Actual)
April 1, 2016
Study Completion (Actual)
April 1, 2016
Study Registration Dates
First Submitted
May 15, 2013
First Submitted That Met QC Criteria
May 15, 2013
First Posted (Estimate)
May 20, 2013
Study Record Updates
Last Update Posted (Actual)
April 26, 2018
Last Update Submitted That Met QC Criteria
April 24, 2018
Last Verified
April 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Genital Neoplasms, Male
- Prostatic Diseases
- Prostatic Neoplasms
- Physiological Effects of Drugs
- Adrenergic beta-Antagonists
- Adrenergic Antagonists
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Anti-Arrhythmia Agents
- Antihypertensive Agents
- Vasodilator Agents
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Cyclooxygenase Inhibitors
- Cyclooxygenase 2 Inhibitors
- Propranolol
- Etodolac
Other Study ID Numbers
- VT1-SYS-601
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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