A PHASE 3, RANDOMIZED, OPEN-LABEL STUDY OF PF-06821497 (MEVROMETOSTAT) IN COMBINATION WITH ENZALUTAMIDE COMPARED WITH ENZALUTAMIDE OR DOCETAXEL IN PARTICIPANTS WITH METASTATIC CASTRATION RESISTANT PROSTATE CANCER PREVIOUSLY TREATED WITH ABIRATERONE ACETATE (MEVPRO-1)

ReclutandoFase 3ClinicalTrials.gov

ID: NCT06551324RENIS: IS004770Tipo: INTERVENTIONALInicio: 21 de oct de 2024Fin estimado: 29 de oct de 2028

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Resumen

Pfizer MEVPRO-1 (C2321014) is a randomized, open-label, multi-center clinical trial evaluating whether combining the study medicine (PF-06821497) with enzalutamide is safe and effective compared to physician's choice of either second-line androgen receptor (AR) directed therapy with enzalutamide or docetaxel (chemotherapy) for treating metastatic castration-resistant prostate cancer (mCRPC) after progression on prior abiraterone acetate treatment. The primary objective of this clinical trial is to assess the radiographic progression free survival (rPFS) of the combination of PF-06821497 plus enzalutamide versus physician's choice of enzalutamide or docetaxel.

Elegibilidad

Edad mínima: 18 YearsSexo: MALE

Criterios de inclusión

Histologically or cytologically confirmed adenocarcinoma of the prostate without small cell features.
Metastatic disease in bone documented on bone scan, or in soft tissue documented on CT/MRI scan.
Progressive disease in the setting of surgical or medical castration with evidence of disease progression on treatment with abiraterone acetate in the mCSPC setting or first line mCRPC setting is required.
Eastern Cooperate Oncology Group (ECOG) performance status 0 - 2, with life expectancy of at least 6 months as assessed by the investigator.

Criterios de exclusión

Any medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may make the participant inappropriate for the study.
Know history of active inflammatory gastrointestinal disease, chronic diarrhea, or previous gastric resection or lap-band surgery.
Clinically significant cardiovascular disease.
Known or suspected brain metastasis or active leptomeningeal disease or clinically significant history of seizure.
Prior treatment for prostate cancer at any stage with any cytotoxic chemotherapy, radioligand therapy (i.e. 177Lu-PSMA-617, radium 223), androgen receptor signaling inhibitors (ARSi) including enzalutamide, apalutamide, darolutamide, poly ADP-ribose polymerase (PARP) monotherapy or other systemic anti-cancer treatment, with the following exceptions:
Treatment with first-generation antiandrogen agents, if discontinued prior to first dose of study intervention.
Docetaxel treatment is allowed for mCSPC, as long as no signs of failure, or disease progression occurred during treatment or within 3 months of treatment completion.
Previous administration with an investigational product within 30 days or 5 half-lives preceding the first dose of study intervention (whichever is shorter).
Inadequate organ function.

Intervenciones

drug

PF-06821497

875 mg BID (2 times a day)

drug

Docetaxel

75 mg/m2 IV (every 21 days)

drug

Enzalutamide

160 mg QD

Ubicaciones

Centro de Urología (CDU)

CABA, Buenos Aires, Argentina

RECRUITING

Hospital Sirio Libanes

Capital Federal, Buenos Aires, Argentina

RECRUITING

Instituto Alexander Fleming

Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina

RECRUITING

Imagenes Mdq

Mar del Plata, Buenos Aires, Argentina

RECRUITING

Instituto de Investigaciones Clínicas Mar del Plata

Mar del Plata, Buenos Aires, Argentina

RECRUITING

Centro Medico Privado CEMAIC

Capital, Córdoba Province, Argentina

RECRUITING

IMAXE

Buenos Aires, Argentina

RECRUITING

Asociación de Beneficencia Hospital Sirio Libanés

Buenos Aires, Argentina

RECRUITING

Centro de Educación Médica e Investigaciones clínicas "Dr. Norberto Quirno" (CEMIC)

Buenos Aires, Argentina

RECRUITING

Patrocinadores

PrincipalPfizer

Contactos

Pfizer CT.gov Call Center

CONTACT

ClinicalTrials.gov_Inquiries@pfizer.com 1-800-718-1021

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A PHASE 3, RANDOMIZED, OPEN-LABEL STUDY OF PF-06821497 (M... | EligiMed