First Line Comparative Study of EN3348 (MCC) vs BCG in NMIBC
28. august 2014 opdateret af: Bioniche Life Sciences Inc.
Randomized, Double-blind, Multi-center Study Comparing MCC to BCG as First Line Immunotherapy in Patients With Non-muscle Invasive (Superficial) Bladder Cancer at High Risk of Recurrence or Progression
The purpose of this study is to compare the safety and efficacy of EN3348 (MCC) versus BCG as first line treatment in patients with non-muscle invasive bladder cancer that are at high risk for recurrence or progression.
Studieoversigt
Status
Trukket tilbage
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Fase
- Fase 3
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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California
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Laguna Hills, California, Forenede Stater
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Los Angeles, California, Forenede Stater
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San Diego, California, Forenede Stater
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Colorado
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Englewood, Colorado, Forenede Stater
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Florida
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Daytona Beach, Florida, Forenede Stater
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Kansas
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Overland Park, Kansas, Forenede Stater
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Louisiana
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Shreveport, Louisiana, Forenede Stater
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New York
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Garden City, New York, Forenede Stater
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New York, New York, Forenede Stater
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Pennsylvania
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Pittsburgh, Pennsylvania, Forenede Stater
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South Carolina
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Myrtle Beach, South Carolina, Forenede Stater
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Texas
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McAllen, Texas, Forenede Stater
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Utah
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Salt Lake City, Utah, Forenede Stater
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Virginia
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Norfolk, Virginia, Forenede Stater
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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
Alle
Beskrivelse
Inclusion Criteria:
- histologically confirmed urothelial carcinoma of the bladder (high grade Ta or T1 papillary lesions, CIS)
- histologically confirmed diagnosis within 42 days of study treatment
- life expectancy of greater than 5 years
- ECOG performance status of 2 or less
- absence of urothelial carcinoma involving the upper urinary tract or prostatic urethra within 12 months from start of study treatment
Exclusion Criteria:
- current or previous history of muscle invasive bladder tumors (>T2)
- current or previous history of lymph node and/or distant metastases from bladder cancer
- current evidence of squamous cell carcinoma, adenocarcinoma or undifferentiated carcinoma of the bladder
- current systemic cancer therapy
- previous immunotherapy for bladder cancer
- previous intravesical chemotherapy treatment
- contraindication to use BCG of known tolerance to BCG
- history of malignancy of any organ system within the past 5 years (with the exception of basal cell or squamous cell carcinoma, stage T1 prostate cancer, carcinoma in situ of the cervix, colon polyps)
- patients who cannot tolerate intravesical administration or intravesical surgical manipulation (cystoscopy or biopsy)
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 |
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Eksperimentel: MCC
Intravesical Administration of Mycobacterial Cell-Wall DNA Complex
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8 mg/50 mL (sterile WFI) Intravesical Administration; one weekly instillation per week for 6 week Induction Phase; three weekly instillations per month at Months 3, 6, 12, 18, and 24 followed by Maintenance Phase.
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Aktiv komparator: BCG
Intravesical Administration of Bacillus Calmette-Guerin
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mg/50 mL (sterile saline) Intravesical Administration; one weekly instillation per week for 6 week Induction Phase; three weekly instillations per month at Months 3, 6, 12, 18, and 24 followed by Maintenance Phase.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Duration of disease-free survival (time to recurrence, progression or death) in all patients
Tidsramme: Baseline, Month 3, 6, 9, 12, 15, 18, 21, and 24
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Baseline, Month 3, 6, 9, 12, 15, 18, 21, and 24
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Percent of patients who due to study drug-related AEs experience 2 consecutive treatment delays or discontinue due to drug related AEs
Tidsramme: Baseline through 24 months
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Baseline through 24 months
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Sekundære resultatmål
Resultatmål |
Tidsramme |
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Disease-free survival rate at 2 years
Tidsramme: Month 24
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Month 24
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Frequency, severity, and nature of drug-related AEs
Tidsramme: Baseline through 24 Months
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Baseline through 24 Months
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Duration of progression-free survival (time to progression or death) in all patients
Tidsramme: Baseline, Month 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 42, 48 and 60
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Baseline, Month 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 42, 48 and 60
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Frequency, severity, and nature of drug-related SAEs
Tidsramme: Baseline through 24 months
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Baseline through 24 months
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Number of treatment delays and their reason
Tidsramme: Baseline, Month 3, 6, 9, 12, 15, 18, 21, and 24
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Baseline, Month 3, 6, 9, 12, 15, 18, 21, and 24
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Frequency, severity and nature of all AEs
Tidsramme: Baseline through 24 months
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Baseline through 24 months
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Number of treatment discontinuations and their reason
Tidsramme: Baseline through 24 months
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Baseline through 24 months
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Duration of Survival (time to death from any cause) in all patients
Tidsramme: Baseline through month 60
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Baseline through month 60
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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. januar 2010
Primær færdiggørelse (Forventet)
1. februar 2014
Studieafslutning (Forventet)
1. februar 2017
Datoer for studieregistrering
Først indsendt
25. januar 2011
Først indsendt, der opfyldte QC-kriterier
25. januar 2011
Først opslået (Skøn)
26. januar 2011
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
29. august 2014
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
28. august 2014
Sidst verificeret
1. august 2014
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- EN3348-302
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 .