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Prostatic NeoplasmsPhase 2NCT01857817

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

A Phase 2 study testing VT-122 in people with Prostatic Neoplasms, run by Vicus Therapeutics at 16 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Prostatic Neoplasms
What is being tested?
VT-122
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
35 participants
Where
16 sitesUnited States
Study dates
Jun 2013to Apr 2016
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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):
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  • 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

Who cannot join

  • 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
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  • 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

Trial locations and contacts

16 sites in 1 country.

16 sites in 1 country

United States16 sites

  • Hendrick Cancer Center

    Abilene, Texas, 79601

  • Manatee Medical Research Institute, LLC

    Bradenton, Florida, 34205

  • Karmanos Cancer Institute

    Detroit, Michigan, 48201

  • Highlands Oncology Group

    Fayetteville, Arkansas, 72703

  • AccuMed Research Associates

    Garden City, New York, 11530

  • Oncology Consultants, P.A.

    Houston, Texas, 77030

  • Baptist Cancer Institute

    Jacksonville, Florida, 32207

  • Detroit Clinical Research Center, PC

    Lansing, Michigan, 48912

  • Advanced Urology

    Parker, Colorado, 80134

  • Premier Medical Group of the Hudson Valley PC

    Poughkeepsie, New York, 12601

  • Redwood Regional Medical Group

    Santa Rosa, California, 95403

  • Adult & Pediatric Urology

    Sartell, Minnesota, 56377

  • Virginia Mason Medical Center

    Seattle, Washington, 98101

  • Medical Oncology Associates, PS

    Spokane, Washington, 99208

  • Montefiore Medical Center

    The Bronx, New York, 10467

  • Midwestern Regional Medical Center

    Zion, Illinois, 60099

Other trials in United States

About this study

Official title: 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.

Being tested
VT-122, Placebo
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • VT-122Drug

    Also called propranolol, etodolac

    The following will be used in the study for VT-122: propranolol 22 mg immediate-release capsules and etodolac 340 mg capsules.

  • PlaceboDrug

    The placebo capsules will be prepared to match the active drug.

Study groups in NCT01857817
Study groupRoleWhat they receive
VT-122 with physician's choice therapyExperimentalParticipants 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.
Receives: Drug: VT-122
Placebo with physician's choice therapyPlacebo comparatorParticipants 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.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in prostate specific antigen (PSA)

    Measured: baseline (Day 1 Cycle 1) to 12 weeks (Day 1, Cycle 4)

Secondary outcomes (5)

  1. PSA progression

    Measured: baseline to 12 weeks

  2. PSA doubling time (PSADT)

    Measured: baseline and every month during treatment

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

    Measured: Day 1 Cycle 1, on Day 1 of each subsequent 28-day cycle, and on end of treatment

  4. Time to symptom progression (TTSP)

    Measured: Day 1 Cycle 1 and Day 1 of each subsequent 28-day cycle

  5. Change in correlative biomarkers

    Measured: Day 1 Cycle 1, on Day 1 of each subsequent 28-day cycle, and on end of treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 May 2013 (estimated)
  2. Study startJun 2013
  3. Primary completionApr 2016
  4. Study completionApr 2016

Why it stopped: Low patient recruitment

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
35 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01857817
Sponsor's protocol ID
VT1-SYS-601
Status last verified
Apr 2018
First submitted
15 May 2013
Last updated
26 Apr 2018
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing VT-122 in people with Prostatic Neoplasms, run by Vicus Therapeutics at 16 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 26 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Low patient recruitment). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in prostate specific antigen (PSA) (time frame: baseline (Day 1 Cycle 1) to 12 weeks (Day 1, Cycle 4)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01857817.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Apr 2018.

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