Last updated 7 days ago
A Study to Test Inavolisib Treatment in Participants With Metastatic Castration-Resistant Prostate Cancer
100 patients around the world
Available in United States, Brazil
Hoffmann-La Roche
1Research sites
100Patients around the world
This study is for people with
Prostate cancer
Castration resistant prostate cancer
Requirements for the patient
From 18 Years
Male
Medical requirements
- Histologically or cytologically confirmed adenocarcinoma of the prostate without small-cell or neuroendocrine features.Progressive metastatic CRPC, defined as any of the following: PSA progression, defined by a minimum of two rising PSA values from three consecutive assessments with an interval of at least 7 days between assessments and with a minimal starting value of PSA >=1 ng/mL; The most recent qualifying PSA value must be determined within 14 days of enrollment; Soft tissue disease progression, defined by Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1); Bone disease progression, defined by PCWG3 criteria, with two or more new metastatic bone lesions on a whole-body radionuclide bone scan.Treatment with at least one, but no more than one, prior second-generation ARPi (abiraterone, apalutamide, enzalutamide, darolutamide) for hormone-sensitive prostate cancer (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 <100 mg/dL and HbA1c < 5.7%.
- Presence of liver metastasis.Prior treatment with any phosphatidylinositol-3-kinase (PI3K), protein kinase B (AKT), or mammalian target of rapamycin (mTOR) inhibitor, or with any agent with a mechanism of action of inhibiting the PI3K/AKT/mTOR pathway.Type 1 or Type 2 diabetes mellitus.Prior treatment for mCRPC with cytotoxic chemotherapy or novel hormonal treatments (e.g., androgen receptor degraders, CYP11 inhibitors), with the following treatments permitted:Prior docetaxel in mHSPC, providing no evidence of disease progression occurred during treatment or within 6 months of treatment completion;Prior docetaxel in the adjuvant or neoadjuvant setting providing no evidence of disease progression occurred during treatment or within 12 months of treatment completion;Prior treatment with sipuleucel-T, with the last dose administered >28 days prior to start of treatment;Prior PARPi therapy, as per local prescribing information, with the last dose administered >14 days prior to start of treatment;One prior RLT or radiotherapeutic agent (e.g., PSMA-targeted RLT, Radium 223) with the last dose administered >8 weeks prior to start of treatment.Other concurrent anti-cancer therapy except for androgen deprivation therapy.Treatment with strong CYP2C8 inhibitors, strong or moderate CYP2C8 inducers, or strong CYP3A4 inducers within 1 week or 5 drug-elimination half-lives, whichever is longer, prior to initiation of study treatment.Transfusion of any blood product for the sole purpose of making a potential participant eligible for study inclusion or within 28 days of enrollment.
Sites
Centro de Estudos e Pesquisas de Hematologia e Oncologia - CEPHO
Recruiting
StudyInavoPC
SponsorHoffmann-La Roche
Study typeInterventional
Conditions
Castration resistant prostate cancer
Requirements
From 18 YearsMale
Unique study IDclinicaltrials.gov
NCT07287150
