Ipatasterib in the treatment of mCRPC: now in Phase III trial


Ipatasterib is a new type of drug that can be used to block the so-called PI3K/Akt signaling pathway, which is often highly activated in men with metastatic, castration-resistant prostate cancer (mCRPC). In May 2016 we reported on data from  a Phase II trial of this drug in  the treatment of mCRPC.

As of July this year, ipatasterib in now being tested in a Phase III clinical trial (the IPATential150 trial) among men with mCRPC. The patients are being randomized to one or other of two types of treatment:

  • Either ipatasertib + abiraterone acetate (Zytiga) + prednisone (or prednisolone)
  • Or a placebo + abiraterone acetate (Zytiga) + prednisone (or prednisolone)

To be eligible for this clinical trial patients must have

  • Histologically confirmed prostate adenocarcinoma without neuroendocrine differentiation or small-cell features
  • Eastern Collaborative Oncology Group (ECOG) performance status of 0 or 1
  • Adequate hematologic and organ function
  • A life expectancy of at least 6 months
  • Metastatic disease documented prior to randomization by bone lesions on bone scan or soft tissue disease by computed tomography (CT) or magnetic resonance imaging (MRI)
  • Asymptomatic or mildly symptomatic prostate cancer
  • Progressive disease before initiating study treatment
  • An ongoing, standard form of androgen deprivation therapy ADT)

Full details of the inclusion and exclusion criteria for this study can be found on the ClinicalTrials.gov web site (study no. NCT03073228).

The trial will be enrolling about 850 patients and is expected to run from now until results are available in 2023.

The primary study endpoint is investigator-assessed, radiographic progression-free survival (rPFS), but there is also a wide spectrum of secondary endpoints, including overall survival.

Trial enrollment is possible at any one of more than 200 sites around the world — with 48 sites being within the USA. (Again, see the ClinicalTrials.gov web site, above, for the list of places where it is possible to enroll in this trial.)

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