- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01857817
Efficacy and Safety Study of Etodolac and Propranolol in Patients With Clinically Progressive Prostate Cancer
24. april 2018 opdateret af: 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.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
35
Fase
- Fase 2
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
Arkansas
-
Fayetteville, Arkansas, Forenede Stater, 72703
- Highlands Oncology Group
-
-
California
-
Santa Rosa, California, Forenede Stater, 95403
- Redwood Regional Medical Group
-
-
Colorado
-
Parker, Colorado, Forenede Stater, 80134
- Advanced Urology
-
-
Florida
-
Bradenton, Florida, Forenede Stater, 34205
- Manatee Medical Research Institute, LLC
-
Jacksonville, Florida, Forenede Stater, 32207
- Baptist Cancer Institute
-
-
Illinois
-
Zion, Illinois, Forenede Stater, 60099
- Midwestern Regional Medical Center
-
-
Michigan
-
Detroit, Michigan, Forenede Stater, 48201
- Karmanos Cancer Institute
-
Lansing, Michigan, Forenede Stater, 48912
- Detroit Clinical Research Center, PC
-
-
Minnesota
-
Sartell, Minnesota, Forenede Stater, 56377
- Adult & Pediatric Urology
-
-
New York
-
Bronx, New York, Forenede Stater, 10467
- Montefiore Medical Center
-
Garden City, New York, Forenede Stater, 11530
- AccuMed Research Associates
-
Poughkeepsie, New York, Forenede Stater, 12601
- Premier Medical Group of the Hudson Valley PC
-
-
Texas
-
Abilene, Texas, Forenede Stater, 79601
- Hendrick Cancer Center
-
Houston, Texas, Forenede Stater, 77030
- Oncology Consultants, P.A.
-
-
Washington
-
Seattle, Washington, Forenede Stater, 98101
- Virginia Mason Medical Center
-
Spokane, Washington, Forenede Stater, 99208
- Medical Oncology Associates, PS
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Han
Beskrivelse
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
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Firedobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: 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.
|
The following will be used in the study for VT-122: propranolol 22 mg immediate-release capsules and etodolac 340 mg capsules.
Andre navne:
|
Placebo komparator: 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.
|
The placebo capsules will be prepared to match the active drug.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
Change in prostate specific antigen (PSA)
Tidsramme: baseline (Day 1 Cycle 1) to 12 weeks (Day 1, Cycle 4)
|
baseline (Day 1 Cycle 1) to 12 weeks (Day 1, Cycle 4)
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
PSA progression
Tidsramme: baseline to 12 weeks
|
baseline to 12 weeks
|
PSA doubling time (PSADT)
Tidsramme: baseline and every month during treatment
|
baseline and every month during treatment
|
Change in self-reported performance (EQ-5D), pain (visual analog scale [VAS] and opiate usage)
Tidsramme: Day 1 Cycle 1, on Day 1 of each subsequent 28-day cycle, and on end of treatment
|
Day 1 Cycle 1, on Day 1 of each subsequent 28-day cycle, and on end of treatment
|
Time to symptom progression (TTSP)
Tidsramme: Day 1 Cycle 1 and Day 1 of each subsequent 28-day cycle
|
Day 1 Cycle 1 and Day 1 of each subsequent 28-day cycle
|
Change in correlative biomarkers
Tidsramme: Day 1 Cycle 1, on Day 1 of each subsequent 28-day cycle, and on end of treatment
|
Day 1 Cycle 1, on Day 1 of each subsequent 28-day cycle, and on end of treatment
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. juni 2013
Primær færdiggørelse (Faktiske)
1. april 2016
Studieafslutning (Faktiske)
1. april 2016
Datoer for studieregistrering
Først indsendt
15. maj 2013
Først indsendt, der opfyldte QC-kriterier
15. maj 2013
Først opslået (Skøn)
20. maj 2013
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
26. april 2018
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
24. april 2018
Sidst verificeret
1. april 2018
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Neoplasmer
- Urogenitale neoplasmer
- Neoplasmer efter sted
- Genitale neoplasmer, mandlige
- Prostatasygdomme
- Prostatiske neoplasmer
- Lægemidlers fysiologiske virkninger
- Adrenerge beta-antagonister
- Adrenerge antagonister
- Adrenerge midler
- Neurotransmittermidler
- Molekylære mekanismer for farmakologisk virkning
- Anti-arytmimidler
- Antihypertensive midler
- Vasodilatorer
- Agenter fra det perifere nervesystem
- Enzymhæmmere
- Analgetika
- Sensoriske systemagenter
- Anti-inflammatoriske midler, ikke-steroide
- Analgetika, ikke-narkotisk
- Anti-inflammatoriske midler
- Antirheumatiske midler
- Cyclooxygenase-hæmmere
- Cyclooxygenase 2-hæmmere
- Propranolol
- Etodolac
Andre undersøgelses-id-numre
- VT1-SYS-601
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med Prostatiske neoplasmer
-
Guangzhou First People's HospitalAfsluttet
Kliniske forsøg med VT-122
-
Vicus TherapeuticsAfsluttet
-
TaiwanJ Pharmaceuticals Co., LtdIkke rekrutterer endnuIkke-alkoholisk Steatohepatitis (NASH) med fibrose
-
John SappRekrutteringMyokardieinfarkt | Ventrikulær takykardi | Hjertesygdom strukturel lidelseCanada
-
University Hospital, BordeauxEIT HealthAktiv, ikke rekrutterendeVentrikulær takykardiFrankrig, Tyskland, Schweiz, Østrig
-
University of Sao Paulo General HospitalBiosense Webster, Inc.AfsluttetTakykardi, VentrikulærBrasilien
-
Tarapeutics Science Inc.RekrutteringRecidiverende eller refraktær akut myeloid leukæmi (AML)Kina
-
Mansoura UniversityIkke rekrutterer endnuPrimær medfødt glaukom
-
University of PittsburghAfsluttet
-
Adagio MedicalIkke rekrutterer endnuVentrikulær takykardiDet Forenede Kongerige
-
CelgeneAfsluttetKlinisk farmakologi, sunde mandlige frivillige undersøgelseForenede Stater