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Purpose

This study will evaluate the efficacy 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.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
Male
Accepts Healthy Volunteers
No

Inclusion Criteria

  • 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%

Exclusion Criteria

  • 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

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Arm 1 		Participants will receive Inavolisib plus enzalutamide
  • Drug: Inavolisib
    Inavolisib will be administered orally as per the schedule specified in the protocol.
  • Drug: Enzalutamide
    Enzalutamide will be administered orally as per the schedule specified in the protocol.
Active Comparator
Arm 2 		Participants will receive either ARPi switch (enzalutamide or abiraterone) or docetaxel
  • Drug: Enzalutamide
    Enzalutamide will be administered orally as per the schedule specified in the protocol.
  • Drug: Abiraterone
    Abiraterone will be administered orally as per the schedule specified in the protocol.
  • Drug: Docetaxel
    Docetaxel will be administered intravenously as per the schedule specified in the protocol.

Recruiting Locations

UCSF
San Francisco, California 94115

Holden Comprehensive Cancer Center
Iowa City, Iowa 52242-1009

Montefiore Einstein Cancer Center
The Bronx, New York 10461

Carolina Urologic Research Center
Myrtle Beach, South Carolina 29572-4607

More Details

Status
Recruiting
Sponsor
Hoffmann-La Roche

Study Contact

Reference Study ID Number: CO45813 https://forpatients.roche.com/
888-662-6728 (U.S. and Canada)
global-roche-genentech-trials@gene.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.