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RecruitingPhase 2interventionalRules rewrite

Phase 2: testing Inavolisib for Metastatic Castration-Resistant Prostate Cancer

This study will measure the how well it works and safety of the combination of inavolisib plus enzalutamide compared with physician's choice of alternative androgen receptor pathway inhibitor (ARPi) or docetaxel in biomarker-selected participants with metastatic castrate-resistant prostate cancer (mCRPC) who have received one prior second-generation ARPi.

Official registry: https://clinicaltrials.gov/study/NCT07287150 · Hoffmann-La Roche · enrollment listed as 100

What this phase means

Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are Inavolisib, Enzalutamide, or Abiraterone. The registry lists allocation as randomized. This study will measure the how well it works and safety of the combination of inavolisib plus enzalutamide compared with physician's choice of alternative androgen receptor pathway inhibitor (ARPi) or docetaxel in biomarker-selected participants with metastatic castrate-resistant prostate cancer (mCRPC) who have received one prior second-generation ARPi.

They plan to enroll about 100 people at 50 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.

Official title (unrewritten)

A Phase II, Randomized, Multicenter, Open-Label Study Evaluating the Efficacy and Safety of the Combination of Inavolisib Plus Enzalutamide Versus Physician's Choice of ARPI or Docetaxel in Patients With Metastatic Castration-Resistant Prostate Cancer

Interventions: Inavolisib, Enzalutamide, Abiraterone, Docetaxel

Primary outcome (registry wording): Radiographic Progression-free Survival (rPFS)

Who it is for (from inclusion criteria)

  • Ages 18 Years to any
  • Men only
  • Histologically or cytologically confirmed adenocarcinoma of the prostate without small-cell or neuroendocrine features
  • Treatment with at least one, but no more than one, prior second-generation ARPi (abiraterone, apalutamide, enzalutamide, darolutamide) for at least 12 weeks for HSPC or CRPC
  • Availability of a tumor tissue specimen that is suitable (e.g., adequate quality and quantity) for use in determining biomarker status
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
  • Fasting glucose \<126 mg/dL and HbA1c \< 6%

Public study contact (from the registry)

Reference Study ID Number: CO45813 https://forpatients.roche.com/ No attachments to email below.

888-662-6728 (U.S. and Canada)

global-roche-genentech-trials@gene.com

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

50 listed

+ 43 sites outside the US on the same record

Related recruiting trials in this snapshot

FAQ about this NCT record

Is NCT07287150 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT07287150?

Phase 2. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT07287150?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

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