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A Phase 2 Study to Evaluate Safety and Efficacy of Abiraterone in Participants With Prostate Cancer

19. oktober 2017 opdateret af: Janssen Research & Development, LLC

A Phase II Study of JNJ-212082 (Abiraterone Acetate) in Metastatic Castration Resistant Prostate Cancer Patients Who Are Chemotherapy-Naïve

The purpose of this study is to investigate safety and efficacy of abiraterone in participants with metastatic castration-resistant prostate cancer (mCRPC) and who have not received prior chemotherapy (treatment of disease, usually cancer, by chemical agents).

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

This is a multi-center (conducted in more than one center), open-label (all people know the identity of the intervention), single-arm study to investigate safety and efficacy of abiraterone. The study consists of 3 phases: Screening phase (consists of 14 days before study commences on Day -1); Treatment phase (consists of 28-daily dosing cycles wherein abiraterone 1000 milligram [mg] once daily along with 5 mg prednisolone twice daily will be given until disease progression or unacceptable toxicity is observed); and Follow-up phase (up to 5 years or until survival after the first dose of study drug). Abiraterone will be orally administered daily as at least 1 hour before the meal or 2 hours after the meal. Dose reduction will be allowed at the Investigator's discretion but not lower than 500 mg per day. Participants will discontinue study treatment at disease progression unless, in the Investigator's opinion, it is deemed that the participants will continue to derive benefit from abiraterone. Efficacy will be evaluated primarily through decline in prostate-specific antigen (substance in blood that is measured to check for prostate cancer) after 12 weeks of therapy. Participants' safety will be monitored throughout the study.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

48

Fase

  • Fase 2

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Japan
      • Asahi, Japan
      • Fukuoka, Japan
      • Gifu, Japan
      • Kanazawa, Japan
      • Kashiwa, Japan
      • Kita-Gun, Japan
      • Kuki, Japan
      • Kurashiki, Japan
      • Maebashi, Japan
      • Matsuyama, Japan
      • Mitaka, Japan
      • Niigata, Japan
      • Osaka, Japan
      • Osaka-Sayama, Japan
      • Sagamihara, Japan
      • Sakura, Japan
      • Sapporo, Japan
      • Yokohama, Japan
      • Yokosuka, Japan

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

20 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Han

Beskrivelse

Inclusion Criteria:

  • In-patients or out-patients with histologically or cytologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation or small cell histology
  • Have surgically or medically castrated, with testosterone levels of less than 50 nanogram per deciliter
  • Have prostate-specific antigen (PSA) level of at least 5 nanogram per milliliter
  • Be under PSA progression according to Prostate-Specific Antigen Working Group (PSAWG) eligibility criteria or objective progression by Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.0 criteria for participants with measurable disease after androgen deprivation
  • Have Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0 or 1

Exclusion Criteria:

  • Has received other hormonal therapy, including any dose of finasteride, dutasteride, any herbal product known to decrease PSA levels or any systemic corticosteroid within 4 weeks prior to Cycle 1 Day 1 or has received ketoconazole for prostate cancer
  • Has received radiotherapy, chemotherapy (including estramustine) or immunotherapy (including provenge) within 4 weeks, or single fraction of palliative radiotherapy within 2 weeks prior to Cycle 1 Day 1
  • Has had surgery or local prostatic intervention within 4 weeks prior to Cycle 1 Day 1. In addition, any clinically relevant sequel from the surgery must have resolved prior to Cycle 1 Day 1
  • Has clinically significant heart disease as evidenced by myocardial infarction, or arterial thrombotic events, severe or unstable angina, or New York Heart Association (NYHA) Class 3 to 4 heart disease or cardiac ejection fraction measurement of less than 50 percent within 6 months prior to Cycle 1 Day 1
  • Has uncontrolled hypertension (systolic blood pressure greater than or equal to 160 millimeter of mercury or diastolic blood pressure greater than or equal to 95 millimeter of mercury)

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: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Abiraterone plus Prednisolone
Abiraterone 1000 milligram (mg) oral tablets will be administered once daily along with 5 mg oral prednisolone tablet administered twice daily for 28-daily dosing cycles and will be continued until disease progression or unacceptable toxicity.
Medicin: Abiraterone
Abirateron vil blive indgivet oralt som 1000 milligram (mg) dagligt i 28-daglige doseringscyklusser, som fortsættes indtil sygdomsprogression eller uacceptabel toksicitet.
Andre navne:
  • JNJ-212082
Medicin: Prednisolon
Prednisolon vil blive indgivet oralt som 5 mg tabletter to gange dagligt i en 28-daglig doseringscyklus, som fortsættes indtil sygdomsprogression eller uacceptabel toksicitet.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Percentage of participants achieving Prostate-Specific Antigen (PSA) response up to 12 weeks
Tidsramme: Baseline up to 12 weeks
The PSA response will be evaluated according to Prostate-Specific Antigen Working Group (PSAWG) criterion, which is, greater than or equal to 50 percent decrease in PSA from Baseline up to 12 weeks after the first dose of study drug, which would be subsequently confirmed by a measurement that is at least 4 or more weeks after initial documentation of PSA.
Baseline up to 12 weeks

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Percentage of participants with Radiographic Objective Response
Tidsramme: Baseline, Day 1 of Cycle 4, 7 and 10, and thereafter every third cycle until first documented disease progression or up to 5 years
Percentage of participants with radiographic objective response is defined as the percentage of participants with complete response (CR) or partial response (PR) as best overall response based on reconciled radiographic disease assessment according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.0. The CR is disappearance of all lesions. The PR is at least 30 percent decrease in sum of the longest diameter of target lesions or persistence of one or more non-target lesion(s) or/and maintenance of tumor marker level above the normal limits.
Baseline, Day 1 of Cycle 4, 7 and 10, and thereafter every third cycle until first documented disease progression or up to 5 years
Duration of Prostate-Specific Antigen (PSA) response
Tidsramme: Baseline and Day 1 of each cycle up to 5 years
Duration of a PSA response is the time taken to achieve a PSA response that is decrease in PSA from Baseline by greater than or equal to 50 percent.
Baseline and Day 1 of each cycle up to 5 years
Percentage of participants achieving Prostate-Specific Antigen (PSA) response
Tidsramme: Baseline and Day 1 of each cycle up to 5 years
The PSA response is decrease in PSA from Baseline by greater than or equal to 50 percent.
Baseline and Day 1 of each cycle up to 5 years
Clinical benefit
Tidsramme: Baseline, Day 1 of Cycle 4, 7 and 10, and thereafter every third cycle up to 5 years
Clinical Benefit is defined as a confirmed complete response (CR), confirmed partial response (PR), or stable disease (SD) according to RECIST Version 1.0. The CR is disappearance of all lesions. The PR is at least 30 percent decrease in sum of the longest diameter of target lesions or persistence of one or more non-target lesion(s) or/and maintenance of tumor marker level above the normal limits. The SD is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease since treatment started.
Baseline, Day 1 of Cycle 4, 7 and 10, and thereafter every third cycle up to 5 years
Eastern Cooperative Oncology Group Performance Status (ECOG PS) score
Tidsramme: Baseline, Day 1, 8, 15 and 22 of Cycle 1 and 2, and thereafter Day 1 and 15 of all cycles up to 5 years
The ECOG PS Score 0 versus 1, wherein 0 signifies fully active, able to carry all pre-disease performance without restriction and 1 signifies restriction in physically strenuous activity but ambulatory and able to carry out work on a light or sedentary nature, for example, light housework, office work.
Baseline, Day 1, 8, 15 and 22 of Cycle 1 and 2, and thereafter Day 1 and 15 of all cycles up to 5 years
Decline in Serum Prostate-Specific Antigen (PSA)
Tidsramme: Baseline and Day 1 of each cycle up to 5 years
Decline in serum PSA according to Prostate Cancer Clinical Trials Working Group 2 (PCWG2) criterion, which is, 25 percent increase in PSA and an absolute increase in PSA level by 2 nanogram per milliliter or more, from Baseline which would be subsequently confirmed by a measurement that is at least 4 or more weeks after initial documentation of PSA.
Baseline and Day 1 of each cycle up to 5 years
Overall survival
Tidsramme: Every 3 months until death or up to 5 years
Overall survival is defined as the time interval from the date of first dose to date of death.
Every 3 months until death or up to 5 years
Prostate-Specific Antigen based Progression-free Survival (PSA-PFS)
Tidsramme: Baseline and Day 1 of each cycle until first documented disease progression or up to 5 years
The PSA-PFS is defined as time to first PSA failure (that is, two consecutive increases in PSA of 50 percent and greater than or equal to 5 nanogram per milliliter, as per Prostate-Specific Antigen Working Group [PSAWG]criterion) or death .
Baseline and Day 1 of each cycle until first documented disease progression or up to 5 years
Radiographic Progression-free Survival (RAD-PFS)
Tidsramme: Baseline, Day 1 of Cycle 4, 7 and 10, and thereafter every third cycle until first documented disease progression or up to 5 years
The RAD-PFS is defined as time from randomization to the earliest objective evidence of radiographic progression or death due to any cause. The RAD-PFS will be evaluated according to RECIST Version 1.0.
Baseline, Day 1 of Cycle 4, 7 and 10, and thereafter every third cycle until first documented disease progression or up to 5 years
Percentage of participants with Circulating Tumor Cell (CTC) conversion
Tidsramme: Day 1 of Cycle 2, 3, and 4
The CTC is the pharmacodynamic potential predictive biomarker for tumor sensitivity.
Day 1 of Cycle 2, 3, and 4

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Janssen Research & Development, LLC

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Hjælpsomme links

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 (Faktiske)

6. juni 2012

Primær færdiggørelse (Faktiske)

17. oktober 2014

Studieafslutning (Faktiske)

17. oktober 2014

Datoer for studieregistrering

Først indsendt

20. december 2012

Først indsendt, der opfyldte QC-kriterier

20. december 2012

Først opslået (Skøn)

27. december 2012

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

23. oktober 2017

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

19. oktober 2017

Sidst verificeret

1. oktober 2017

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • CR017059
  • JNJ-212082-JPN-201

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

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 .

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