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

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ClinicalTrials.gov Identifier: NCT01857817
Recruitment Status : Terminated (Low patient recruitment)
First Posted : May 20, 2013
Last Update Posted : April 26, 2018
Sponsor:
Information provided by (Responsible Party):
Vicus Therapeutics

May 15, 2013
May 20, 2013
April 26, 2018
June 2013
April 2016   (Final data collection date for primary outcome measure)
Change in prostate specific antigen (PSA) [ Time Frame: baseline (Day 1 Cycle 1) to 12 weeks (Day 1, Cycle 4) ]
Time to Treatment Failure (TTF) [ Time Frame: up to 3 months ]
Complete list of historical versions of study NCT01857817 on ClinicalTrials.gov Archive Site
  • PSA progression [ Time Frame: baseline to 12 weeks ]
  • PSA doubling time (PSADT) [ Time Frame: baseline and every month during treatment ]
  • 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 ]
  • Time to symptom progression (TTSP) [ Time Frame: Day 1 Cycle 1 and Day 1 of each subsequent 28-day cycle ]
  • Change in correlative biomarkers [ Time Frame: Day 1 Cycle 1, on Day 1 of each subsequent 28-day cycle, and on end of treatment ]
  • Patient Reported Outcome [Functional Assessment of Cancer Therapy-General (FACT G)] [ Time Frame: baseline and every 28 days for 3 months ]
  • Performance (Karnofsky Performance Score, KPS) [ Time Frame: baseline and every 28 days for 3 months ]
  • Disease progression assessed by prostate-specific antigen (PSA), imaging or death [ Time Frame: up to 3 months ]
  • Overall Survival (OS) in participants [ Time Frame: up to 3 months ]
  • Progression Free Survival (PFS) [ Time Frame: up to 3 months ]
  • Time to symptom progression (TTSP) [ Time Frame: up to 3 months ]
  • Change in self-reported performance (EQ-5D), pain [visual analog scale (VAS) and opiate usage] [ Time Frame: baseline and every 28 days for 3 months ]
  • Change in correlative biomarkers [e.g., C-reactive protein (CRP), interleukin-6 (IL-6), urine collagen-type I N- telopeptide (NTx)] [ Time Frame: baseline and every 28 days for 3 months ]
Not Provided
Not Provided
 
Efficacy and Safety Study of Etodolac and Propranolol in Patients With Clinically Progressive Prostate Cancer
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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Prostatic Neoplasms
  • 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
  • Drug: Placebo
    The placebo capsules will be prepared to match the active drug.
  • 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.
    Intervention: Drug: VT-122
  • 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.
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
35
90
April 2016
April 2016   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Male
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01857817
VT1-SYS-601
Not Provided
Not Provided
Not Provided
Vicus Therapeutics
Vicus Therapeutics
Not Provided
Not Provided
Vicus Therapeutics
April 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP