NCT04404140

A Study Evaluating The Safety, Efficacy and Pharmacokinetics Of Ipatasertib In Combination With Atezolizumab And Docetaxel In Metastatic Castration-Resistant Prostate Cancer (mCRPC).

Terminated Phase 1 Last updated 17 October 2023

What this trial tests

Phase 1 trial testing Ipatasertib in Castration-Resistant Prostatic Cancer in 6 participants. Terminated before completion.

Timeline

9 July 2020

Primary endpoint
14 October 2022

14 October 2022

Quick facts

Lead sponsor	Hoffmann-La Roche
Phase	Phase 1
Status	Terminated
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	6
Start date	9 July 2020
Primary completion	14 October 2022
Estimated completion	14 October 2022
Sites	9 locations across France, Switzerland, Spain, Italy

Drugs / interventions tested

• Ipatasertib (ipatasertib) — full drug profile →
• Atezolizumab (atezolizumab) — full drug profile →
• Docetaxel (Docetaxel) — full drug profile →

Conditions studied

• Castration-Resistant Prostatic Cancer — all drugs for Castration-Resistant Prostatic Cancer →

Sponsor

Hoffmann-La Roche — full company profile →

Who can join

18 and older, male only, with Castration-Resistant Prostatic Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

A study evaluating the safety, preliminary efficacy and pharmacokinetics of ipatasertib in combination with atezolizumab and docetaxel in participants with mCRPC previously treated with second-generation AR (Androgen Receptor)-targeted therapy. The study consists of two parts: \[1\] Part A: Safety run-in cohort of approximately 12 participants; \[2\] Part B: Expansion cohort of approximately 38 participants. All participants in this study will continue to be treated until progression of disease, loss of clinical benefit, unacceptable toxicity or withdrawal of consent.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Role of PI3K-AKT-mTOR Pathway as a Pro-Survival Signaling and Resistance-Mediating Mechanism to Therapy of Prostate Cancer.
   Pungsrinont T, Kallenbach J, Baniahmad A. · · 2021 · cited 148× · PMID 34681745 · DOI 10.3390/ijms222011088
2. The PTEN Conundrum: How to Target PTEN-Deficient Prostate Cancer.
   Turnham DJ, Bullock N, Dass MS, Staffurth JN, et al · · 2020 · cited 52× · PMID 33105713 · DOI 10.3390/cells9112342
3. Overview of the Development and Use of Akt Inhibitors in Prostate Cancer.
   Gasmi A, Roubaud G, Dariane C, Barret E, et al · · 2021 · cited 29× · PMID 35011901 · DOI 10.3390/jcm11010160
4. Immunometabolism in cancer: basic mechanisms and new targeting strategy.
   Su R, Shao Y, Huang M, Liu D, et al · · 2024 · cited 28× · PMID 38755125 · DOI 10.1038/s41420-024-02006-2
5. An Insight on Novel Molecular Pathways in Metastatic Prostate Cancer: A Focus on DDR, MSI and AKT.
   Mollica V, Marchetti A, Rosellini M, Nuvola G, et al · · 2021 · cited 26× · PMID 34948314 · DOI 10.3390/ijms222413519
6. Androgen Receptor Signaling Inhibition in Advanced Castration Resistance Prostate Cancer: What Is Expected for the Near Future?
   Pozas J, Álvarez Rodríguez S, Fernández VA, Burgos J, et al · · 2022 · cited 16× · PMID 36551557 · DOI 10.3390/cancers14246071
7. Epigenetic regulation of mRNA mediates the phenotypic plasticity of cancer cells during metastasis and therapeutic resistance (Review).
   Zhang C, Liang S, Zhang H, Wang R, et al · · 2024 · cited 9× · PMID 38131215 · DOI 10.3892/or.2023.8687
8. Quo Vadis Advanced Prostate Cancer Therapy? Novel Treatment Perspectives and Possible Future Directions.
   Kvízová J, Pavlíčková V, Kmoníčková E, Ruml T, et al · · 2021 · cited 4× · PMID 33921501 · DOI 10.3390/molecules26082228