Ignite Creation Date:
2025-12-24 @ 4:45 PM
Ignite Modification Date:
2025-12-25 @ 2:32 PM
Study NCT ID:
NCT07287150
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-12-17
First Post:
2025-12-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study to Test Inavolisib Treatment in Participants With Metastatic Castration-Resistant Prostate Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C000723546', 'term': 'inavolisib'}, {'id': 'C540278', 'term': 'enzalutamide'}, {'id': 'C089740', 'term': 'abiraterone'}, {'id': 'D000077143', 'term': 'Docetaxel'}], 'ancestors': [{'id': 'D043823', 'term': 'Taxoids'}, {'id': 'D043822', 'term': 'Cyclodecanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D004224', 'term': 'Diterpenes'}, {'id': 'D013729', 'term': 'Terpenes'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-03-31', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2029-07-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-11', 'studyFirstSubmitDate': '2025-12-11', 'studyFirstSubmitQcDate': '2025-12-11', 'lastUpdatePostDateStruct': {'date': '2025-12-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-12-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2027-05-14', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Radiographic Progression-free Survival (rPFS)', 'timeFrame': 'Up to approximately 5 years'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants with Confirmed Composite Response Rate (RR)', 'timeFrame': 'Up to approximately 5 years'}, {'measure': 'Percentage of Participants with Confirmed Prostate-Specific Antigen 90 (PSA90)', 'timeFrame': 'Up to approximately 5 years'}, {'measure': 'Percentage of Participants with Confirmed Prostate-Specific Antigen 50 (PSA50)', 'timeFrame': 'Up to approximately 5 years'}, {'measure': 'Objective Response Rate (ORR)', 'timeFrame': 'Up to approximately 5 years'}, {'measure': 'Duration of Response (DOR)', 'timeFrame': 'Up to approximately 5 years'}, {'measure': 'Overall Survival (OS)', 'timeFrame': 'Up to approximately 5 years'}, {'measure': 'Percentage of Participants With Adverse Events (AEs)', 'timeFrame': 'Up to approximately 5 years'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Metastatic Castration-Resistant Prostate Cancer']}, 'descriptionModule': {'briefSummary': "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."}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histologically or cytologically confirmed adenocarcinoma of the prostate without small-cell or neuroendocrine features\n* Progressive metastatic CRPC, defied 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\n* 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\n* Availability of a tumor tissue specimen that is suitable (e.g., adequate quality and quantity) for use in determining biomarker status\n* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1\n* Fasting glucose \\</= 100 mg/dL and HbA1c \\< 5.7%\n\nExclusion Criteria:\n\n* Presence of liver metastasis\n* 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\n* Type 1 or Type 2 diabetes mellitus\n* 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\n* 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\n* Other concurrent anti-cancer therapy except for androgen deprivation therapy\n* 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\n* Transfusion of any blood product for the sole purpose of making a potential participant eligible for study inclusion or within 28 days of enrollment'}, 'identificationModule': {'nctId': 'NCT07287150', 'acronym': 'InavoPC', 'briefTitle': 'A Study to Test Inavolisib Treatment in Participants With Metastatic Castration-Resistant Prostate Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hoffmann-La Roche'}, 'officialTitle': "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 Docetaxal in Patients With Metastatis Castration-Resistant Prostate Cancer", 'orgStudyIdInfo': {'id': 'CO45813'}, 'secondaryIdInfos': [{'id': '2025-521327-67-00', 'type': 'CTIS'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm 1', 'description': 'Participants will receive Inavolisib plus enzalutamide', 'interventionNames': ['Drug: Inavolisib', 'Drug: Enzalutamide', 'Diagnostic Test: FoundationOne® CDx (F1CDx) Assay']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Arm 2', 'description': 'Participants will receive either ARPi switch (enzalutamide or abiraterone) or docetaxel', 'interventionNames': ['Drug: Enzalutamide', 'Drug: Abiraterone', 'Drug: Docetaxel', 'Diagnostic Test: FoundationOne® CDx (F1CDx) Assay']}], 'interventions': [{'name': 'Inavolisib', 'type': 'DRUG', 'description': 'Inavolisib will be administered orally as per the schedule specified in the protocol.', 'armGroupLabels': ['Arm 1']}, {'name': 'Enzalutamide', 'type': 'DRUG', 'description': 'Enzalutamide will be administered orally as per the schedule specified in the protocol.', 'armGroupLabels': ['Arm 1', 'Arm 2']}, {'name': 'Abiraterone', 'type': 'DRUG', 'description': 'Abiraterone will be administered orally as per the schedule specified in the protocol.', 'armGroupLabels': ['Arm 2']}, {'name': 'Docetaxel', 'type': 'DRUG', 'description': 'Docetaxel will be administered intravenously as per the schedule specified in the protocol.', 'armGroupLabels': ['Arm 2']}, {'name': 'FoundationOne® CDx (F1CDx) Assay', 'type': 'DIAGNOSTIC_TEST', 'description': "F1CDx is a next-generation sequencing (NGS)-based in vitro diagnostic test that will be used to determine a participant's biomarker status.", 'armGroupLabels': ['Arm 1', 'Arm 2']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Reference Study ID Number: CO45813 https://forpatients.roche.com/', 'role': 'CONTACT', 'email': 'global-roche-genentech-trials@gene.com', 'phone': '888-662-6728 (U.S. and Canada)'}], 'overallOfficials': [{'name': 'Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hoffmann-La Roche'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': "For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data\\_sharing"}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hoffmann-La Roche', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}