Informations générales (source: ClinicalTrials.gov)
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)
Interventional
Phase 3
Pfizer (Voir sur ClinicalTrials)
octobre 2024
octobre 2028
02 décembre 2025
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.
Etablissements
| Etablissement | Contact | Statut | Actualisé | ||
|---|---|---|---|---|---|
| Etablissement non spécifié, référez vous à la page NCT pour plus d'information Origine et niveau de fiabilité des données | |||||
Critères
Homme
- 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.
Exclusion Criteria:
- 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:
1. Treatment with first-generation antiandrogen agents, if discontinued prior to
first dose of study intervention.
2. 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.