Therapy Detail
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| Therapy Name | CC-115 + Enzalutamide |
| Synonyms | |
| Therapy Description | |
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| Drug Name | Trade Name | Synonyms | Drug Classes | Drug Description |
|---|---|---|---|---|
| CC-115 | mTOR Inhibitor 51 | CC-115 binds to and inhibits the activity of DNA-PK and mTOR, which may lead to reduced cell proliferation, block downstream signaling, and induce cell death (PMID: 27235137, PMID: 31853198). | ||
| Enzalutamide | Xtandi | MDV3100|ASP9785 | Hormone - Anti-androgens 47 | Xtandi (enzalutamide) is a second-generation small molecule inhibitor of androgen receptor, thereby resulting in decreased tumor growth (PMID: 24009414, PMID: 25945058). Xtandi (enzalutamide) is FDA-approved for use in patients with castration-resistant prostate cancer, metastatic hormone-sensitive prostate cancer, and non-metastatic castration-sensitive prostate cancer with biochemical recurrence at high risk for metastasis (FDA.gov). |
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| Molecular Profile | Indication/Tumor Type | Response Type | Therapy Name | Approval Status | Evidence Type | Efficacy Evidence | References |
|---|---|---|---|---|---|---|---|
| TSC2 loss | castration-resistant prostate carcinoma | predicted - sensitive | CC-115 + Enzalutamide | Phase I | Actionable | In a Phase Ib trial, combination of Xtandi (enzalutamide) and CC-115 was safe and resulted in a PSA reduction >= 50% (PSA50) in 80% and >=90% (PSA90) in 58% of patients with metastatic castration-resistant prostate cancer at 12 weeks, patients harboring PIK3CA activating mutations or TSC1/2 loss (n=16) achieved superior PSA50, PSA90, and median time on treatment (94%, 63%, 57 wks) compared to PI3K pathway wild-type (n=24) patients (71%, 54%, 44 wks) (Ann Oncol (2021) 32 (suppl_5): S626-S677; NCT02833883). | detail... |
| PTEN inact mut | castration-resistant prostate carcinoma | predicted - sensitive | CC-115 + Enzalutamide | Phase I | Actionable | In a Phase Ib trial, Xtandi (enzalutamide) and CC-115 combination therapy was safe and resulted in a PSA reduction >= 50% (PSA50) in 80% (32/40) and >=90% (PSA90) in 58% of patients with metastatic castration-resistant prostate cancer at 12 weeks, patients harboring PTEN mutation or deletion (n=11) achieved superior PSA50, PSA90, and median time on treatment (91%, 55%, 59 wks) compared to PTEN wild-type (n=29) patients (76%, 59%, 44 wks) (Ann Oncol (2021) 32 (suppl_5): S626-S677; NCT02833883). | detail... |
| PIK3CA act mut | castration-resistant prostate carcinoma | predicted - sensitive | CC-115 + Enzalutamide | Phase I | Actionable | In a Phase Ib trial, combination of Xtandi (enzalutamide) and CC-115 was safe and resulted in a PSA reduction >= 50% (PSA50) in 80% and >=90% (PSA90) in 58% of patients with metastatic castration-resistant prostate cancer at 12 weeks, patients harboring PIK3CA activating mutations or TSC1/2 loss (n=16) achieved superior PSA50, PSA90, and median time on treatment (94%, 63%, 57 wks) compared to PI3K pathway wild-type (n=24) patients (71%, 54%, 44 wks) (Ann Oncol (2021) 32 (suppl_5): S626-S677; NCT02833883). | detail... |
| TSC1 loss | castration-resistant prostate carcinoma | predicted - sensitive | CC-115 + Enzalutamide | Phase I | Actionable | In a Phase Ib trial, combination of Xtandi (enzalutamide) and CC-115 was safe and resulted in a PSA reduction >= 50% (PSA50) in 80% and >=90% (PSA90) in 58% of patients with metastatic castration-resistant prostate cancer at 12 weeks, patients harboring PIK3CA activating mutations or TSC1/2 loss (n=16) achieved superior PSA50, PSA90, and median time on treatment (94%, 63%, 57 wks) compared to PI3K pathway wild-type (n=24) patients (71%, 54%, 44 wks) (Ann Oncol (2021) 32 (suppl_5): S626-S677; NCT02833883). | detail... |
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| Clinical Trial | Phase | Therapies | Title | Recruitment Status | Covered Countries | Other Countries |
|---|---|---|---|---|---|---|
| NCT02833883 | Phase I | CC-115 + Enzalutamide | Use of an Experimental Drug, CC-115, With Enzalutamide in Men With Castration-Resistant Prostate Cancer | Completed | USA | 0 |
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