Therapy Detail
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| Therapy Name | GDC-0980 |
| Synonyms | |
| Therapy Description |
Apitolisib (GDC-0980) is an inhibitor of both PI3K and mTOR kinases, resulting in decreased phosphorylation of PI3K/Akt/mTOR pathway markers, which may lead to inhibition of tumor growth and tumor regression (PMID: 21998291). |
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| Drug Name | Trade Name | Synonyms | Drug Classes | Drug Description |
|---|---|---|---|---|
| GDC-0980 | Apitolisib | mTOR Inhibitor 51 PI3K Inhibitor (Pan) 39 | Apitolisib (GDC-0980) is an inhibitor of both PI3K and mTOR kinases, resulting in decreased phosphorylation of PI3K/Akt/mTOR pathway markers, which may lead to inhibition of tumor growth and tumor regression (PMID: 21998291, PMID: 30914027). |
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- Use quotes to match a longer phrase which contains spaces "mtor c1483f"
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| Molecular Profile | Indication/Tumor Type | Response Type | Therapy Name | Approval Status | Evidence Type | Efficacy Evidence | References |
|---|---|---|---|---|---|---|---|
| VHL inact mut | renal cell carcinoma | no benefit | GDC-0980 | Phase II | Actionable | In a retrospective analysis from a Phase II clinical trial, patients with metastatic renal cell carcinoma treated with Apitolisib (GDC-0980) had no difference in progression free survival when stratified by the presence (n=5) or absence (n=17) of deleterious VHL mutations (PMID: 26951309). | 26951309 |
| PIK3CA E542K | head and neck squamous cell carcinoma | sensitive | GDC-0980 | Phase I | Actionable | In a Phase I trial, Apitolisib (GDC-0980) treatment resulted in a partial response in a patient with head and neck squamous cell carcinoma harboring a PIK3CA E542K mutation (PMID: 26787751). | 26787751 |
| PIK3CA R88Q | malignant pleural mesothelioma | sensitive | GDC-0980 | Phase I | Actionable | In a Phase I trial, treatment with Apitolisib (GDC-0980) resulted in a partial response in a patient with malignant pleural mesothelioma harboring PIK3CA R88Q (PMID: 26787751). | 26787751 |
| PTEN mutant | endometrial cancer | sensitive | GDC-0980 | Phase II | Actionable | In a Phase II trial, Apitolisib (GDC-0980) was poorly tolerated, but demonstrated efficacy in endometrial cancer patients harboring mutations in PIK3CA, PTEN, or AKT1 (J Clin Oncol 32:5s, 2014 (suppl; abstr 5513)). | detail... |
| PIK3CA mutant | endometrial cancer | sensitive | GDC-0980 | Phase II | Actionable | In a Phase II trial, Apitolisib (GDC-0980) was poorly tolerated, but demonstrated efficacy in endometrial cancer patients harboring mutations in PIK3CA, PTEN, or AKT1 (J Clin Oncol 32:5s, 2014 (suppl; abstr 5513)). | detail... |
| PIK3CA E545K | Advanced Solid Tumor | sensitive | GDC-0980 | Phase I | Actionable | In a Phase I trial, Apitolisib (GDC-0980) resulted in a partial response in two patients, one with head and neck squamous cell carcinoma and another with ovarian cancer, both harboring PIK3CA E545K (PMID: 26787751). | 26787751 |
| PTEN dec exp | renal cell carcinoma | no benefit | GDC-0980 | Phase II | Actionable | In a retrospective analysis from a Phase II clinical trial, patients with metastatic renal cell carcinoma treated with Apitolisib (GDC-0980) had no difference in progression free survival when stratified by high expression (n=17) and low expression (n=19) of Pten (PMID: 26951309). | 26951309 |
| PIK3CA act mut PTEN dec exp | renal cell carcinoma | no benefit | GDC-0980 | Phase II | Actionable | In a retrospective analysis from a Phase II clinical trial, patients with metastatic renal cell carcinoma treated with Apitolisib (GDC-0980) had no difference in progression free survival when stratified by the presence (n=21) or absence (n=15) of PIK3CA activating mutation or loss of Pten expression (PMID: 26951309). | 26951309 |
| PIK3CA mutant | Advanced Solid Tumor | sensitive | GDC-0980 | Phase I | Actionable | In a Phase I trial, Apitolisib (GDC-0980) treatment resulted in partial response in 21% (3/14) and stable disease in 57% (8/14) of patients with advanced solid tumors harboring PIK3CA mutations (PMID: 26787751). | 26787751 |
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| Clinical Trial | Phase | Therapies | Title | Recruitment Status | Covered Countries | Other Countries |
|---|---|---|---|---|---|---|
| NCT01485861 | Phase II | GDC-0980 Abiraterone Ipatasertib | Study of GDC-0068 Or GDC-0980 With Abiraterone Acetate Versus Abiraterone Acetate in Patients With Castration-Resistant Prostate Cancer Previously Treated With Docetaxel Chemotherapy | Active, not recruiting | USA | ITA | FRA | ESP | 5 |
| NCT00854152 | Phase I | GDC-0980 | A Study Evaluating GDC-0980 Administered Once Daily in Patients With Refractory Solid Tumors or Non-Hodgkin's Lymphoma | Completed | USA | 1 |
| NCT01437566 | Phase II | GDC-0980 Fulvestrant Pictilisib | Study of GDC-0941 or GDC-0980 With Fulvestrant Versus Fulvestrant in Advanced or Metastatic Breast Cancer in Patients Resistant to Aromatase Inhibitor Therapy | Completed | USA | ITA | FRA | ESP | DEU | CAN | BEL | 16 |
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