- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02656615
Abiraterone-Rechallenge Study for CRPC Patients (ABI-RE)
An Open Label Biomarker Driven Phase II Clinical Trial of Abiraterone Acetate (AA) Re-Challenge in Patients With Metastatic Castration-Resistant Prostate Cancer and Prior Response to AA
Studieoversigt
Detaljeret beskrivelse
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Fase 2
Kontakter og lokationer
Studiesteder
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Basel, Schweiz, 4000
- University Hospital Basel
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St.Gallen, Schweiz, 9007
- Cantonal Hospital St.Gallen
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Graubuenden
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Chur, Graubuenden, Schweiz, 7000
- Cantonal Hospital Chur
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Written prostate cancer.
- Adult patients with histological or cytological diagnosis of adenocarcinoma of the prostate.
- Men with castration-resistant metastatic decline maintained for at least 3 weeks as per PCWG2 criteria).
- Confirmed biochemical response to prior abiraterone acetate (≥50% PSA Informed Consent (including consent for biomarker studies including the fresh tumour biopsies)
- Progressive disease according to PCWG2 criteria during prior therapy with standard dose of abiraterone acetate (confirmed increase of PSA ≥25% over nadir) or soft-tissue or bone progression. Patients that have stopped abiraterone acetate for reasons other than progression are not eligible.
Documented progression of disease by any of the criteria listed here:
- PSA
- Soft tissue
- Bone scan all as per PCWG2 criteria
- Patients may have received treatment with docetaxel, enzalutamide or radium-223
- PSA of ≥10ug/l
- ECOG performance status 0 - 2
- At least 3 months (90 days) since stop of prior abiraterone acetate.
Exclusion Criteria:
- Major surgery within 28 days weeks prior to start of treatment
- Prior treatment with cabazitaxel or the CYP-17 inhibitor TAK-700/orteronel
- Any concurrent treatment or prior treatment with an investigational drug within 28 days prior to start of treatment.
- Known brain or leptomeningeal disease
- Concurrent use of steroids other than prednisone >10mg/d
Inadequate bone marrow and organ function as evidenced by:
Platelet count <75 x 10 G/L ASAT and/or ALAT ≥ 2.5 x ULN Total bilirubin ≥ 1.5 x ULN (≥ 2.0 x ULN for patients with Gilbert's disease) Hypokalaemia despite adequate supplementation Creatinine Clearance <30ml/min
- Uncontrolled hypertension or cardiac failure or LVEF <50%
creatinine clearance is to be calculated by using the formula of Cockcroft-Gault in appendix 4 of the protocol
Studieplan
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 |
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Eksperimentel: Abiraterone
Abiraterone acetate 1000 mg once daily and Prednisone 2x5 mg daily (continuously as per prescription label).
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Abiraterone acetate 1000 mg once daily and Prednisone 2x5 mg daily (continuously as per prescription label).
Andre navne:
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Response rate
Tidsramme: at week 12
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Soft-tissue and PSA Response per PCWG2
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at week 12
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Rate of CTC conversion
Tidsramme: Measured at baseline and at 12 weeks
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Rate of CTC conversion from a baseline count of ≥5/7.5ml to <5/7.5ml
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Measured at baseline and at 12 weeks
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Rate of PSA decline 30%
Tidsramme: at week 12
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Rate of PSA declines of ≥30% at 12 weeks and at any time on study thereafter
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at week 12
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rPFS
Tidsramme: From date of start of treatment up to 6 months
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From date of start of treatment until the date of first documented progression or date of death from any cause, whichever came first
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From date of start of treatment up to 6 months
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Disease control rate
Tidsramme: at 12 and 24 weeks
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Disease control rate at 12 and 24 weeks (defined as SD, PR, CR, see response criteria)
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at 12 and 24 weeks
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Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Aurelius G Omlin, MD, Cantonal Hospital St. Gallen
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
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
- Molekylære mekanismer for farmakologisk virkning
- Enzymhæmmere
- Antineoplastiske midler
- Hormoner, hormonsubstitutter og hormonantagonister
- Cytokrom P-450 enzymhæmmere
- Hormonantagonister
- Steroidsyntesehæmmere
- Abirateronacetat
Andre undersøgelses-id-numre
- CTU 14/020
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
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Kliniske forsøg med abiraterone acetate
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Radboud University Medical CenterAfsluttet
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Jiangnan UniversityAffiliated Hospital of Jiangnan UniversityRekrutteringKastrationsresistent prostatakræftKina
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Zhongnan HospitalAktiv, ikke rekrutterendeFarmakokinetisk | Abirateronacetat | Plasma koncentration | Gen polymorfisme | Metabolisk analyseKina
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Uppsala UniversityAfsluttetPostoperative komplikationer | Væsketerapi | Væskeoverbelastning | Pancreas sygdom | Postoperativ periodeSverige
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Daniel VaenaAfsluttetProstatakræft | Kastratresistent prostatakræftForenede Stater
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Karolinska InstitutetAfsluttet
-
Wendell Yap, MDUniversity of Kansas Medical CenterIkke længere tilgængeligProstatakræftForenede Stater
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University of Alabama at BirminghamIkke rekrutterer endnu
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University of PennsylvaniaAfsluttetMild kognitiv svækkelseForenede Stater
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Veru Inc.AfsluttetMetastatisk kastrationsresistent prostatakræft | Androgen resistent prostatakræftForenede Stater