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

This study is currently recruiting participants.
Verified March 2014 by Vicus Therapeutics
Sponsor:
Information provided by (Responsible Party):
Vicus Therapeutics
ClinicalTrials.gov Identifier:
NCT01857817
First received: May 15, 2013
Last updated: March 6, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention Phase
Prostatic Neoplasms
Drug: VT-122
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Placebo Controlled, Multicenter Phase 2 Study of Etodolac and Propranolol in Patients With Clinically Progressive Prostate Cancer

Resource links provided by NLM:


Further study details as provided by Vicus Therapeutics:

Primary Outcome Measures:
  • Change in prostate specific antigen (PSA) [ Time Frame: baseline (Day 1 Cycle 1) to 12 weeks (Day 1, Cycle 4) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • PSA progression [ Time Frame: baseline to 12 weeks ] [ Designated as safety issue: No ]
  • PSA doubling time (PSADT) [ Time Frame: baseline and every month during treatment ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Time to symptom progression (TTSP) [ Time Frame: Day 1 Cycle 1 and Day 1 of each subsequent 28-day cycle ] [ Designated as safety issue: No ]
  • Change in correlative biomarkers [ Time Frame: Day 1 Cycle 1, on Day 1 of each subsequent 28-day cycle, and on end of treatment ] [ Designated as safety issue: No ]

Estimated Enrollment: 90
Study Start Date: June 2013
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Drug: VT-122
The following will be used in the study for VT-122: propranolol 22 mg immediate-release capsules and etodolac 340 mg capsules.
Other Names:
  • propranolol
  • etodolac
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.
Drug: Placebo
The placebo capsules will be prepared to match the active drug.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01857817

Contacts
Contact: Natalie Salt 416-305-7800 vicusteam@axiommetrics.com
Contact: Joseph Ko 416-274-6290 vicusteam@axiommetrics.com

  Show 23 Study Locations
Sponsors and Collaborators
Vicus Therapeutics
  More Information

No publications provided

Responsible Party: Vicus Therapeutics
ClinicalTrials.gov Identifier: NCT01857817     History of Changes
Other Study ID Numbers: VT1-SYS-601
Study First Received: May 15, 2013
Last Updated: March 6, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Neoplasms
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases
Propranolol
Etodolac
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Antihypertensive Agents
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Vasodilator Agents
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on April 15, 2014