Denne siden ble automatisk oversatt og nøyaktigheten av oversettelsen er ikke garantert. Vennligst referer til engelsk versjon for en kildetekst.

En studie av Apalutamid (ARN-509) hos menn med ikke-metastatisk kastrasjonsresistent prostatakreft (SPARTAN)

24. september 2026 oppdatert av: Aragon Pharmaceuticals, Inc.

En multisenter, randomisert, dobbeltblind, placebokontrollert, fase III-studie av ARN-509 hos menn med ikke-metastatisk (M0) kastrasjonsresistent prostatakreft

The purpose of this study is to evaluate the efficacy and safety of apalutamide in adult men with high-risk non-metastatic castration-resistant prostate cancer.

Studieoversikt

Status

Aktiv, ikke rekrutterende

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

This Phase 3 clinical trial is an essential step in the evaluation of an investigational medication to see if it may be useful in treating prostate cancer. The purpose of the SPARTAN study is to compare the safety and effectiveness of the investigational medication to placebo in delaying prostate cancer from spreading to other parts of the body. A placebo is a pill that looks like the investigational medication but does not contain any active medication, a dummy pill.

Phase 3 studies are performed after preliminary evidence suggesting effectiveness of the drug has been obtained in previous Phase 2 studies. These studies are intended to gather the additional information about effectiveness and safety that is needed to evaluate the overall benefit-risk relationship of the drug.

Study participants will take the oral investigational medication daily. One cycle of study treatment lasts 4 weeks or 28 days. The number of cycles will depend on how you and your cancer respond to the study medication.

In order for the researchers to evaluate and compare the study results, there are two different study groups. Study participants will be randomly (like flipping a coin) assigned to one of these groups:

  • One group will receive their current treatment along with the investigational medication
  • One group will receive their current medications along with a placebo

The investigational medication will be given to 2 out of every 3 study participants. Neither you nor the study staff will know which group you are in. However, in case of a medical emergency, your study doctor can quickly find out which treatment group you are in.

All participants will continue to receive their current treatment along with either the investigational medication or a placebo. The selections will be random, and you may remain on investigational treatment until your disease worsens, or until significant side effects occur or you can no longer tolerate treatment.

Studietype

Intervensjonell

Registrering (Faktiske)

1207

Fase

  • Fase 3

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Australia
      • Adelaide, Australia
      • Box Hill, Australia
      • Camperdown, Australia
      • Darlinghurst, Australia
      • Geelong, Australia
      • Gosford, Australia
      • Hobart, Australia
      • Kogarah, Australia
      • Liverpool, Australia
      • Melbourne, Australia
      • Nedlands, Australia
      • Parkville, Australia
      • South Woodville, Australia
      • Southport, Australia
      • Sydney, Australia
      • Tweed Heads, Australia
      • Wollongong, Australia
  • Belgia
      • Brussels, Belgia
      • Ghent, Belgia
      • Kortrijk, Belgia
      • Leuven, Belgia
      • Liège, Belgia
      • Ottignies, Belgia
  • Canada
    • Alberta
      • Calgary, Alberta, Canada
      • Edmonton, Alberta, Canada
    • British Columbia
      • Abbotsford British Columbia, British Columbia, Canada
      • Kelowna, British Columbia, Canada
      • Vancouver, British Columbia, Canada
      • Victoria, British Columbia, Canada
    • New Brunswick
      • Moncton, New Brunswick, Canada
      • Saint John, New Brunswick, Canada
    • Nova Scotia
      • Halifax, Nova Scotia, Canada
    • Ontario
      • Barrie, Ontario, Canada
      • Brampton, Ontario, Canada
      • Brantford, Ontario, Canada
      • Hamilton, Ontario, Canada
      • London, Ontario, Canada
      • North York, Ontario, Canada
      • Oakville, Ontario, Canada
      • Ottawa, Ontario, Canada
      • Owen Sound, Ontario, Canada
      • Toronto, Ontario, Canada
    • Quebec
      • Gatineau, Quebec, Canada
      • Granby, Quebec, Canada
      • Greenfield Park, Quebec, Canada
      • Laval, Quebec, Canada
      • Montreal, Quebec, Canada
      • Pointe-Claire, Quebec, Canada
      • Québec, Quebec, Canada
      • Sherbrooke, Quebec, Canada
  • Danmark
      • Aalborg C, Danmark
      • Copenhagen, Danmark
      • Odense, Danmark
      • Roskilde, Danmark
  • Finland
      • Helsinki, Finland
      • Oulu, Finland
      • Seinäjoki, Finland
      • Tampere, Finland
      • Turku, Finland
  • Forente stater
    • Alabama
      • Birmingham, Alabama, Forente stater
    • Alaska
      • Anchorage, Alaska, Forente stater
    • Arizona
      • Chandler, Arizona, Forente stater
      • Tucson, Arizona, Forente stater
    • California
      • Duarte, California, Forente stater
      • Fullerton, California, Forente stater
      • Laguna Woods, California, Forente stater
      • Los Angeles, California, Forente stater
      • Orange, California, Forente stater
      • Roseville, California, Forente stater
      • Sacramento, California, Forente stater
      • San Bernardino, California, Forente stater
      • San Diego, California, Forente stater
      • San Francisco, California, Forente stater
      • Santa Monica, California, Forente stater
      • Sherman Oaks, California, Forente stater
      • Stanford, California, Forente stater
      • Tarzana, California, Forente stater
      • Torrance, California, Forente stater
    • Colorado
      • Denver, Colorado, Forente stater
      • Englewood, Colorado, Forente stater
      • Glenwood Springs, Colorado, Forente stater
      • Grand Junction, Colorado, Forente stater
    • District of Columbia
      • Washington D.C., District of Columbia, Forente stater
    • Florida
      • Aventura, Florida, Forente stater
      • Boca Raton, Florida, Forente stater
      • Bradenton, Florida, Forente stater
      • Daytona Beach, Florida, Forente stater
      • Fort Myers, Florida, Forente stater
      • Hialeah, Florida, Forente stater
      • Jacksonville, Florida, Forente stater
      • Miami, Florida, Forente stater
      • New Port Richey, Florida, Forente stater
      • Orlando, Florida, Forente stater
      • Sarasota, Florida, Forente stater
      • St. Petersburg, Florida, Forente stater
      • Wellington, Florida, Forente stater
    • Idaho
      • Meridian, Idaho, Forente stater
    • Illinois
      • Chicago, Illinois, Forente stater
      • Decatur, Illinois, Forente stater
      • Maywood, Illinois, Forente stater
      • Melrose Park, Illinois, Forente stater
    • Indiana
      • Carmel, Indiana, Forente stater
      • Jeffersonville, Indiana, Forente stater
      • Muncie, Indiana, Forente stater
    • Iowa
      • West Des Moines, Iowa, Forente stater
    • Kansas
      • Westwood, Kansas, Forente stater
      • Wichita, Kansas, Forente stater
    • Louisiana
      • Metairie, Louisiana, Forente stater
      • New Orleans, Louisiana, Forente stater
    • Maryland
      • Annapolis, Maryland, Forente stater
      • Baltimore, Maryland, Forente stater
      • Rockville, Maryland, Forente stater
      • Towson, Maryland, Forente stater
    • Massachusetts
      • Boston, Massachusetts, Forente stater
    • Michigan
      • Detroit, Michigan, Forente stater
      • Lansing, Michigan, Forente stater
      • Minneapolis, Michigan, Forente stater
      • Royal Oak, Michigan, Forente stater
    • Minnesota
      • Duluth, Minnesota, Forente stater
    • Mississippi
      • Bay Saint Louis, Mississippi, Forente stater
      • Southaven, Mississippi, Forente stater
    • Missouri
      • Kansas City, Missouri, Forente stater
    • Montana
      • Missoula, Montana, Forente stater
    • Nebraska
      • Omaha, Nebraska, Forente stater
    • Nevada
      • Las Vegas, Nevada, Forente stater
    • New Hampshire
      • Hooksett, New Hampshire, Forente stater
    • New Jersey
      • Hackensack, New Jersey, Forente stater
      • Lawrenceville, New Jersey, Forente stater
      • Morristown, New Jersey, Forente stater
      • Mount Laurel, New Jersey, Forente stater
      • New Brunswick, New Jersey, Forente stater
      • Voorhees Township, New Jersey, Forente stater
    • New Mexico
      • Albuquerque, New Mexico, Forente stater
    • New York
      • Albany, New York, Forente stater
      • Mineola, New York, Forente stater
      • New York, New York, Forente stater
      • Oneida, New York, Forente stater
      • Poughkeepsie, New York, Forente stater
      • Syracuse, New York, Forente stater
      • The Bronx, New York, Forente stater
    • North Carolina
      • Concord, North Carolina, Forente stater
      • Greensboro, North Carolina, Forente stater
      • Greenville, North Carolina, Forente stater
      • Salisbury, North Carolina, Forente stater
      • Winston-Salem, North Carolina, Forente stater
    • Ohio
      • Cincinnati, Ohio, Forente stater
      • Cleveland, Ohio, Forente stater
      • Middleburg Heights, Ohio, Forente stater
      • Middletown, Ohio, Forente stater
    • Oregon
      • Bend, Oregon, Forente stater
      • Portland, Oregon, Forente stater
      • Tualatin, Oregon, Forente stater
    • Pennsylvania
      • Bala-Cynwyd, Pennsylvania, Forente stater
      • Bryn Mawr, Pennsylvania, Forente stater
      • Lancaster, Pennsylvania, Forente stater
      • Philadelphia, Pennsylvania, Forente stater
      • Pittsburgh, Pennsylvania, Forente stater
    • Rhode Island
      • Warwick, Rhode Island, Forente stater
    • South Carolina
      • Charleston, South Carolina, Forente stater
      • Greenville, South Carolina, Forente stater
      • Myrtle Beach, South Carolina, Forente stater
      • West Columbia, South Carolina, Forente stater
    • Tennessee
      • Memphis, Tennessee, Forente stater
      • Nashville, Tennessee, Forente stater
    • Texas
      • Abilene, Texas, Forente stater
      • Amarillo, Texas, Forente stater
      • Dallas, Texas, Forente stater
      • Fort Sam Houston, Texas, Forente stater
      • Houston, Texas, Forente stater
      • McAllen, Texas, Forente stater
      • San Antonio, Texas, Forente stater
    • Virginia
      • Norfolk, Virginia, Forente stater
      • Richmond, Virginia, Forente stater
      • Virginia Beach, Virginia, Forente stater
    • Washington
      • Burien, Washington, Forente stater
      • Edmonds, Washington, Forente stater
      • Seattle, Washington, Forente stater
      • Tacoma, Washington, Forente stater
    • Wisconsin
      • Green Bay, Wisconsin, Forente stater
      • Madison, Wisconsin, Forente stater
      • Milwaukee, Wisconsin, Forente stater
  • Frankrike
      • Angers, Frankrike
      • Besançon, Frankrike
      • Bordeaux, Frankrike
      • Caen Cédex 05, Frankrike
      • Clermont-Ferrand, Frankrike
      • Hyers, Frankrike
      • La Roche-sur-Yon, Frankrike
      • Le Mans, Frankrike
      • Lille Cedex N/a, Frankrike
      • Lyon, Frankrike
      • Marseille, Frankrike
      • Nice, Frankrike
      • Nîmes, Frankrike
      • Paris, Frankrike
      • Reims, Frankrike
      • Rennes, Frankrike
      • Rouen, Frankrike
      • Saint-Grégoire, Frankrike
      • Saint-Herblain, Frankrike
      • Strasbourg, Frankrike
      • Suresnes, Frankrike
      • Tours, Frankrike
      • Vandœuvre-lès-Nancy, Frankrike
  • Israel
      • Haifa, Israel
      • Jeruselem, Israel
      • Kfar Saba, Israel
      • Petah Tikva, Israel
      • Ramat Gan, Israel
      • Tel Aviv, Israel
      • Tsrifin, Israel
  • Japan
      • Akita, Japan
      • Fukuoka, Japan
      • Gifu, Japan
      • Hakodate, Japan
      • Hiroshima, Japan
      • Hokkaido, Japan
      • Kanazawa, Japan
      • Kashiwa, Japan
      • Kita-Gun, Japan
      • Kobe, Japan
      • Koshigaya, Japan
      • Kumamoto, Japan
      • Kurume, Japan
      • Matsuyama, Japan
      • Nagano, Japan
      • Nagasaki, Japan
      • Nagoya, Japan
      • Niigata, Japan
      • Osaka, Japan
      • Sagamihara, Japan
      • Sakura, Japan
      • Sapporo, Japan
      • Shinjuku-Ku, Japan
      • Tokushima, Japan
      • Tokyo, Japan
      • Ube, Japan
      • Wakayama, Japan
      • Yokohama, Japan
      • Ōsaka-sayama, Japan
  • Nederland
      • Alkmaar, Nederland
      • Eindhoven, Nederland
      • Hoofddorp, Nederland
      • Leidschendam, Nederland
      • Nijmegen, Nederland
      • Rotterdam, Nederland
  • New Zealand
      • Auckland, New Zealand
      • Christchurch, New Zealand
      • Hamilton, New Zealand
      • Nelson, New Zealand
      • Tauranga, New Zealand
      • Whangarei, New Zealand
  • Norge
      • Nordbyhagen, Norge
  • Polen
      • Bialystok, Polen
      • Bydgoszcz, Polen
      • Gdansk, Polen
      • Kutno, Polen
      • Lodz, Polen
      • Poznan, Polen
      • Szczecin, Polen
      • Torun, Polen
      • Warsaw, Polen
      • Wroclaw, Polen
  • Romania
      • Baia Mare, Romania
      • Brasov, Romania
      • Bucharest, Romania
      • Cluj-Napoca, Romania
      • Târgu Mureş, Romania
  • Russland
      • Barnaul, Russland
      • Ivanovo, Russland
      • Moscow, Russland
      • Obninsk, Russland
      • Omsk, Russland
      • Ryazan, Russland
      • Saint Petersburg, Russland
      • Ufa, Russland
      • Yaroslavl, Russland
      • Yekaterinburg, Russland
  • Slovakia
      • Banská Bystrica, Slovakia
      • Bratislava, Slovakia
      • Martin, Slovakia
      • Nitra, Slovakia
      • Trenčín, Slovakia
  • Spania
      • A Coruña, Spania
      • Badalona, Spania
      • Barcelona, Spania
      • Castellon, Spania
      • Girona, Spania
      • Guadalajara, Spania
      • Jerez de la Frontera, Spania
      • Las Palmas de Gran Canaria, Spania
      • Madrid, Spania
      • Murcia, Spania
      • Málaga, Spania
      • Palma de Mallorca, Spania
      • Pamplona, Spania
      • Sabadell, Spania
      • Salamanca, Spania
      • San Sebastián de los Reyes, Spania
      • Santander, Spania
      • Seville, Spania
      • Valencia, Spania
  • Storbritannia
      • Blackburn, Storbritannia
      • Cambridge, Storbritannia
      • Cardiff, Storbritannia
      • Dundee, Storbritannia
      • Glasgow, Storbritannia
      • Guildford, Storbritannia
      • Leeds, Storbritannia
      • London, Storbritannia
      • Maidstone, Storbritannia
      • Metropolitan Borough of Wirral, Storbritannia
      • Nottingham, Storbritannia
      • Plymouth, Storbritannia
      • Southampton, Storbritannia
      • Surrey, Storbritannia
      • Swansea, Storbritannia
      • Wolverhampton, Storbritannia
  • Sverige
      • Gothenburg, Sverige
      • Stockholm, Sverige
      • Umeå, Sverige
      • Uppsala, Sverige
      • Örebro, Sverige
  • Sør -Korea
      • Daegu, Sør -Korea
      • Gwangju, Sør -Korea
      • Pusan, Sør -Korea
      • Seongnam, Sør -Korea
      • Seoul, Sør -Korea
  • Taiwan
      • Kaohsiung City, Taiwan
      • Taichung, Taiwan
      • Taipei, Taiwan
      • Taoyuan County, Taiwan
  • Tsjekkia
      • Liberec, Tsjekkia
      • Olomouc, Tsjekkia
      • Opava, Tsjekkia
      • Pilsen, Tsjekkia
      • Prague, Tsjekkia
  • Tyskland
      • Aachen, Tyskland
      • Bergisch Gladbach, Tyskland
      • Berlin, Tyskland
      • Braunschweig, Tyskland
      • Cologne, Tyskland
      • Duisburg, Tyskland
      • Emmendingen, Tyskland
      • Frankfurt am Main, Tyskland
      • Greifswald, Tyskland
      • Göttingen, Tyskland
      • Hamburg, Tyskland
      • Hanover, Tyskland
      • Heidelberg, Tyskland
      • Heinsberg, Tyskland
      • Homburg/Saar, Tyskland
      • Jena, Tyskland
      • Kiel, Tyskland
      • Kirchheim unter Teck, Tyskland
      • Magdeburg, Tyskland
      • Mainz, Tyskland
      • Mannheim, Tyskland
      • Marburg, Tyskland
      • Mettmann, Tyskland
      • Müllheim, Tyskland
      • Münster, Tyskland
      • Nürtingen, Tyskland
      • Regensburg, Tyskland
      • Rostock, Tyskland
      • Tübingen, Tyskland
      • Weiden, Tyskland
      • Wilhelmshaven, Tyskland
      • Wuppertan, Tyskland
      • Zirndorf, Tyskland
  • Ungarn
      • Budapest, Ungarn
      • Miskolc, Ungarn
      • Nyíregyhá, Ungarn
      • Sopron, Ungarn
      • Szentes, Ungarn
  • Østerrike
      • Graz, Østerrike
      • Innsbruck, Østerrike
      • Linz, Østerrike
      • Vienna, Østerrike

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Mann

Beskrivelse

Inclusion Criteria:

  • Histologically or cytologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation or small cell features with high risk for development of metastases, defined as prostate-specific antigen doubling time (PSADT) less than or equal to (<=) 10 months. PSADT is calculated using at least 3 prostate-specific antigen (PSA) values obtained during continuous ADT (androgen deprivation therapy)
  • Castration-resistant prostate cancer demonstrated during continuous ADT, defined as 3 PSA rises, at least 1 week apart, with the last PSA greater than (>) 2 nanogram per milliliter (ng/mL)
  • Maintain castrate levels of testosterone within 4 weeks prior to randomization and throughout the study
  • Patients currently receiving bone loss prevention treatment with bone-sparing agents must be on stable doses for at least 4 weeks prior to randomization
  • Patients who received a first generation anti-androgen (for example, bicalutamide, flutamide, nilutamide) must have at least a 4-week washout prior to randomization AND must show continuing disease (PSA) progression (an increase in PSA) after washout
  • At least 4 weeks must have elapsed from the use of 5-alpha reductase inhibitors, estrogens, and any other anti-cancer therapy prior to randomization
  • At least 4 weeks must have elapsed from major surgery or radiation therapy prior to randomization
  • Eastern Cooperative Oncology Group Performance Status 0 or 1
  • Resolution of all acute toxic effects of prior therapy or surgical procedure to Grade <= 1 or baseline prior to randomization
  • Adequate organ function according to protocol-defined criteria
  • Administration of growth factors or blood transfusions will not be allowed within 4 weeks of the hematology labs required to confirm eligibility

Exclusion Criteria:

  • Presence of confirmed distant metastases, including central nervous system and vertebral or meningeal involvement
  • Symptomatic local or regional disease requiring medical intervention
  • Prior treatment with second generation anti-androgens
  • Prior treatment with CYP17 inhibitors
  • Prior treatment with radiopharmaceutical agents, or any other investigational agent for non-metastatic castration-resistant prostate cancer
  • Prior chemotherapy for prostate cancer except if administered in the adjuvant/neoadjuvant setting
  • History of seizure or condition that may pre-dispose to seizure
  • Concurrent therapy with protocol-defined excluded medications
  • History or evidence of any of the following conditions: any prior malignancy (other than adequately treated basal cell or squamous cell skin cancer, superficial bladder cancer, or any other cancer in situ currently in complete remission) within 5 years prior to randomization; severe/unstable angina, myocardial infarction, symptomatic congestive heart failure, arterial or venous thromboembolic events, or clinically significant ventricular arrhythmias within 6 months prior to randomization; uncontrolled hypertension; gastrointestinal disorder affecting absorption; active infection; and, any other condition that, in the opinion of the investigator, would impair the patient's ability to comply with study procedures

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Trippel

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Behandlingsarm A: Apalutamid
Legemiddel: Apalutamide

240 mg tablets administered by mouth on a continuous once daily dosing regimen
Placebo komparator: Behandlingsarm B: Placebo
Legemiddel: Placebo

Matched placebo tablets administered by mouth on a continuous once daily dosing regimen

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Metastasis-Free Survival (MFS) by Blinded Independent Central Review (BICR)
Tidsramme: Up to approximately 43 Months

MFS was defined as the time from randomization to the time of first evidence of BICR-confirmed bone or soft tissue distant metastasis or death due to any cause, whichever occurred first. The MFS data for participants without metastasis or death were performed for US or ex-US regulatory purposes. Radiographic scans (bone scans and computerized tomography [CT] or magnetic resonance imaging [MRI] of the chest, abdomen, and pelvis) were performed for detection of metastasis throughout the study.
Up to approximately 43 Months

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Time to Metastasis (TTM)
Tidsramme: Up to approximately 43 Months

Time to metastasis (TTM) was defined as the time from randomization to the time of the scan that showed first evidence of BICR-confirmed radiographically detected bone or soft tissue distant metastasis. The TTM data for participants without metastasis were performed for US or ex-US regulatory purposes. Radiographic scans (bone scans and CT or MRI of the chest, abdomen, and pelvis) were performed for detection of metastasis throughout the study.
Up to approximately 43 Months
Progression-free Survival (PFS)
Tidsramme: Up to approximately 43 Months

PFS defined as time from randomization to first documentation of BICR-confirmed radiographic progressive disease (PD) (development of distant/local/regional metastasis)/death due to any cause whichever occurred first. PFS data for participants without loco-regional disease were performed for US/ex-US regulatory purposes. Radiographic scans (bone scans and CT/MRI of chest,abdomen,pelvis) performed for detection of metastasis throughout study. PD based on RECIST v1.1; Subjects with one measurable lesion, At least 20% increase in sum of diameters of target lesions taking as reference smallest sum on study. In addition, sum must demonstrate an absolute increase of at least 5 millimeter(mm). Also, appearance of one/more new lesions was also considered PD. Subjects with non-measurable disease as per CT/MRI scans, unequivocal progression/appearance of one or more new lesions was considered PD. For new bone lesions detected on bone scans, second imaging (CT/MRI) was required to confirm PD.
Up to approximately 43 Months
Time to Symptomatic Progression
Tidsramme: Up to approximately 43 Months

Time to symptomatic progression was defined as the time from randomization to documentation in the CRF of any of the following (whichever occurred earlier): a) development of a skeletal-related event (pathologic fracture, spinal cord compression, or need for surgical intervention or radiation therapy to the bone); b) pain progression or worsening of disease-related symptoms requiring initiation of a new systemic anti-cancer therapy; or c) development of clinically significant symptoms due to loco-regional tumor progression requiring surgical intervention or radiation therapy.
Up to approximately 43 Months
Overall Survival
Tidsramme: Up to approximately 43 months

Overall survival was defined as the time from randomization to the date of death due to any cause.
Up to approximately 43 months
Time to Initiation of Cytotoxic Chemotherapy
Tidsramme: Up to approximately 43 months

Time to initiation of cytotoxic chemotherapy was defined as the time from randomization to the date of initiation of cytotoxic chemotherapy for prostate cancer.
Up to approximately 43 months

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Aragon Pharmaceuticals, Inc.

Etterforskere

  • Studieleder: Aragon Pharmaceuticals, Inc. Clinical Trial, Aragon Pharmaceuticals, Inc.

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

14. oktober 2013

Primær fullføring (Faktiske)

19. mai 2017

Studiet fullført (Antatt)

31. desember 2027

Datoer for studieregistrering

Først innsendt

17. september 2013

Først innsendt som oppfylte QC-kriteriene

17. september 2013

Først lagt ut (Antatt)

19. september 2013

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

28. september 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

24. september 2026

Sist bekreftet

1. september 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • CR102931
  • 2012-004322-24 (EudraCT-nummer)
  • ARN-509-003; 56021927PCR1007 (Annen identifikator: Janssen Research & Development, LLC)

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Abonnere