Inavolisib — Drug Intelligence | 16 EU Trials

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16 Registered trials

11 Recruiting

5 Completed trials

5 Sponsors

14 Countries

Phase III

Phase II

Phase III: 5 Phase II: 10 Phase I/II: 1

Oversight events:

1 temporary halt 1 urgent safety measure across 2 trials

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Indications tested

Breast cancer 4 Breast cancer metastatic 2 Ovarian epithelial cancer 1 Neoadjuvant therapy 1 Hormone receptor positive breast cancer 1 Prostate cancer metastatic 1

Sponsors using this IMP

F. Hoffmann-La Roche AG 12 Deutsches Krebsforschungszentrum Stiftung Des Oeffentlichen Rechts 1 GBG Forschungs GmbH 1 IRCCS Istituto Nazionale Tumori Fondazione Pascale 1 Medica Scientia Innovation Research S.L. 1

All trials

16 total

Inavolisib for PIK3CA mutated advanced endometrial cancer: a multicentric, phase II, MITO END-4 trial Recruiting

2025-522981-61-00 Phase II 1 country IRCCS Istituto Nazionale Tumori Fondazione Pascale
A Study to Test Inavolisib Treatment in Patients With Metastatic Castration-Resistant Prostate Cancer Recruiting

2025-521327-67-00 Phase II 4 countries F. Hoffmann-La Roche AG
A Phase II Study Evaluating the Efficacy and Safety of Inavolisib plus Ribociclib plus Fulvestrant Versus Placebo plus Ribociclib plus Fulve… Recruiting

2025-523013-28-00 Phase II 5 countries F. Hoffmann-La Roche AG
A proof of concept study to evaluate treatments´efficacy by monitoring Minimal Residual Disease using ctDNA in HR-positive/HER2-negative ear… Recruiting

2023-505661-89-00 Phase II 4 countries Medica Scientia Innovation Research S.L.
A randomized, open-label, phase II trial comparing neoadjuvant endocrine therapy in combination with trastuzumab, pertuzumab +/- the PI3K in… Recruiting

2022-501152-28-00 Phase II 7 countries GBG Forschungs GmbH
To Study the Effect of Inavolisib in Combination with Fulvestrant in Participants with Breast Cancer Recruiting

2025-522805-39-00 Phase II 2 countries F. Hoffmann-La Roche AG
A Study to Assess safety and Effectiveness of the Inavolisib Plus a CDK4/6 Inhibitor and Letrozole Versus Placebo Plus a CDK4/6 Inhibitor an… Recruiting

2024-516162-11-00 Phase III 5 countries F. Hoffmann-La Roche AG
A Study Evaluating the Efficacy and Safety of Inavolisib Plus Phesgo (pertuzumab, trastuzumab, and rHuPH20 injection for SC use) versus plac… Recruiting

2022-502046-28-00 Phase III 7 countries F. Hoffmann-La Roche AG
Genomics guided targeted post-neoadjuvant therapy in patients with early breast cancer – a multicenter, open-label, umbrella phase-II study … Recruiting

2024-514022-23-00 Phase II 1 country Deutsches Krebsforschungszentrum Stiftung Des Oeffentlichen Rechts
A Rollover Study for Patients Previously Enrolled in a Genentech and/or F.Hoffman-La Roche Sponsored Study Recruiting

2023-504263-16-00 Phase III 4 countries F. Hoffmann-La Roche AG
A Study to Evaluate Efficacy and Safety of Multiple Treatment Combinations in Patients with Metastatic Breast Cancer (MORPHEUS-panBC) Recruiting

2023-503629-20-00 Phase I/II 3 countries F. Hoffmann-La Roche AG
A Study to Test Inavolisib Treatments in Patients with Early-Stage, PIK3CA-Mutated Breast Cancer Ended

2024-518811-20-00 Phase II 2 countries F. Hoffmann-La Roche AG
A Study Evaluating the Efficacy and Safety of Inavolisib Plus Fulvestrant Versus Alpelisib Plus Fulvestrant in Patients with Hormone Recepto… Ended

2022-502322-41-00 Phase III 6 countries F. Hoffmann-La Roche AG
A Study Evaluating the Efficacy and Safety of Biomarker-Driven Therapies in Patients With Persistent or Recurrent Rare Epithelial Ovarian Tu… Ended

2023-508194-89-00 Phase II 5 countries F. Hoffmann-La Roche AG
Tumor-Agnostic Precision Immuno-Oncology and Somatic Targeting Rational for You (TAPISTRY) Platform Study Ended

2023-507418-28-00 Phase II 8 countries F. Hoffmann-La Roche AG
A Study Evaluating the Efficacy and Safety of Inavolisib Plus Palbociclib and Fulvestrant versus Placebo Plus Palbociclib and Fulvestrant in… Ended

2023-505812-39-00 Phase III 9 countries F. Hoffmann-La Roche AG

Showing 1–16 of 16 trials

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