Table 2.
Ongoing trials in Prostate Cancer using Akt inhibitors.
| Drug | Phase | NCT Number | Conditions | Investigator | Regimen | Status | Title of the Study | Primary Outcome |
|---|---|---|---|---|---|---|---|---|
| Capivasertib | III | NCT04493853 | De novo metastatic hormone-sensitive prostate cancer with PTEN deficiency |
AstraZeneca | Capivasertib + Abiraterone | Recruiting | A double-blind, randomised, placebo-controlled study assessing the efficacy and safety of Capivasertib + Abiraterone versus placebo+abiraterone as a treatment for patients with denovo metastatic hormone-sensitive prostate cancer characterised by PTEN deficiency. | Radiographic progression-free survival (rPFS). |
| Capivasertib (AZD5363) |
I | NCT04087174 | Metastatic castration-resistant prostate cancer | AstraZeneca Parexel |
Cabivasertibe + Enzalutamide or Abiraterone | Completed | Open-label, multi-centre study to assess the safety, tolerability, and pharmacokinetics of Capivasertib (AZD5363) in combination with novel agents in patients with metastatic castration resistant prostate cancer. | Number of patients with dose-limiting toxicity and number of patients with adverse events. |
| MK2206 | I | NCT01480154 | Solid neoplasm, melanoma, prostate and kidney cancers | Jyoti Malhotra (Rutgers Cancer Institute of New Jersey) |
Akt inhibitor MK2206 + Hydroxychloroquine | Active, not recruiting | Akt inhibitor MK2206 and hydroxychloroquine in treating patients with Advanced solid tumours, melanoma, prostate or kidney cancer. | To define the maximum tolerated dose of MK-2206 and hydroxychloroquine when used in combination. |
| Ipatasertib (GDC-0068) |
Ib/II | NCT01485861 | Castration-resistant prostate cancer previously treated with Docetaxel | Genentech, Inc. | Ipatasertibe or Apitolisilib + Abiraterone | Active, not recruiting | Ipatasertib (GDC-0068) or Apitolisib (GDC-0980) with Abiraterone Acetate versus Abiraterone Acetate in patients with castration-resistant prostate cancer previously treated with Docetaxel-based chemotherapy. | Recommended phase II dose of Ipatasertib, percentage of radiographic progression and progression free survival with or without PTEN loss. |
| Ipatasertib | Ib | NCT04404140 | Metastatic castration-resistant prostate cancer | Hoffmann-La Roche | Ipatasertib + Atezolizumab + Docetaxel | Recruiting | A multicentre study evaluating the safety, efficacy and pharmacokinetics of Ipatasertib In combination with Atezolizumab and Docetaxel in metastatic castration-resistant prostate cancer. | Percentage of patients with adverse events, confirmed PSA response, overall response rate. |
| Ipatasertib | I | NCT04737109 | Breast, ovarian and prostate cancers | Hoffmann-La Roche | Ipatasertib + Rucaparib | Active, not recruiting | A multicentre study evaluating the safety and efficacy of Ipatasertib in combination with Rucaparib in patients with advanced breast, ovarian, or prostate cancer. | Percentage of patients with adverse events, maximum-dose tolerated of the Ipatersertib and Rucaparib combination, percentage of patients with PSA response |
| Ipatasertib | I | NCT03673787 | Solid tumour, glioblastoma, metastatic prostate cancer | Juanita Lopez (National Health Service, UK) |
Ipatasertib + Atezolizumab | Recruiting | Ipatasertib in combination with Atezolizumab in patients with advanced solid tumours with PI3K pathway hyperactivation. | To determine the maximum tolerated dose in Phase I. Number and type of treatment-related adverse events of the two drugs combination. |
| Ipatasertib | I/II | NCT04737109 | Localised high-risk prostate cancer | David VanderWeele (Northwestern University) |
Ipatasertib + Darolutamide | Recruiting | Neoadjuvant androgen deprivation, Darolutamide, and Ipatasertib in men with localised, high-risk prostate cancer. | Pathological Complete Response Rate |