Therapy Detail
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| Therapy Name | Abiraterone + Ipatasertib |
| Synonyms | |
| Therapy Description | |
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| Drug Name | Trade Name | Synonyms | Drug Classes | Drug Description |
|---|---|---|---|---|
| Abiraterone | Zytiga | CB7630 | Hormone - Anti-androgens 54 | Zytiga (abiraterone) inhibits cytochrome P-450c17, resulting in decreased androgen synthesis (PMID: 25560485). Zytiga (abiraterone) is FDA approved for patients with metastatic castration-resistant prostate cancer (FDA.gov). |
| Ipatasertib | GDC-0068|RG-7440 | Akt Inhibitor (Pan) 21 | Ipatasertib (GDC-0068) binds to and inhibits the activity of AKT in an ATP-competitive manner, which may result in the inhibition of the PI3K-AKT signaling pathway and tumor cell proliferation (PMID: 22934575, PMID: 32205017). |
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| Molecular Profile | Indication/Tumor Type | Response Type | Therapy Name | Approval Status | Evidence Type | Efficacy Evidence | References |
|---|---|---|---|---|---|---|---|
| PTEN loss | castration-resistant prostate carcinoma | sensitive | Abiraterone + Ipatasertib | Phase III | Actionable | In a Phase III trial, Ipatasertib (GDC-0068) combined with Zytiga (abiraterone) significantly improved median radiographical progression-free survival (PFS) (18.5 vs 16.5 mo, HR 0.77, p=0.034) in patients with metastatic castration resistant prostate cancer harboring PTEN loss (by IHC) when compared to placebo combined with Zytiga, median PFS was not improved (19.2 vs 16.6 mo, HR 0.84, p=0.043) in the intent-to-treat population (PMID: 34246347; NCT03072238). | 34246347 |
| PTEN loss | castration-resistant prostate carcinoma | sensitive | Abiraterone + Ipatasertib | Phase II | Actionable | In a Phase II trial, the combination of Ipatasertib (GDC-0068) and Zytiga (abiraterone) resulted in a better progression-free survival in metastatic castration resistant prostate cancer patients with PTEN loss (by IHC) when compared to placebo combined with Zytiga (PMID: 30037818; NCT01485861). | 30037818 detail... |
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| Clinical Trial | Phase | Therapies | Title | Recruitment Status | Covered Countries | Other Countries |
|---|---|---|---|---|---|---|
| NCT03072238 | Phase III | Abiraterone Abiraterone + Ipatasertib | Ipatasertib Plus Abiraterone Plus Prednisone/Prednisolone, Relative to Placebo Plus Abiraterone Plus Prednisone/Prednisolone in Adult Male Patients With Metastatic Castrate-Resistant Prostate Cancer | Completed | USA | POL | NOR | ITA | ISR | IRL | HUN | GRC | GBR | FRA | ESP | DNK | CAN | BRA | BEL | AUT | AUS | 9 |
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