Therapy Detail
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| Therapy Name | Ipatasertib + Paclitaxel |
| Synonyms | |
| Therapy Description | |
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| Drug Name | Trade Name | Synonyms | Drug Classes | Drug Description |
|---|---|---|---|---|
| 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). | |
| Paclitaxel | Taxol | 7-Epipaclitaxel | Antimicrotubule Agent 14 BCL2 Family Inhibitor 6 | Taxol (paclitaxel) binds to tubulin to inhibit microtubule disassembly, which results in decreased cell division, and also binds to the anti-apoptotic factor Bcl-2, promoting apoptosis (NCI Drug Dictionary). |
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| Molecular Profile | Indication/Tumor Type | Response Type | Therapy Name | Approval Status | Evidence Type | Efficacy Evidence | References |
|---|---|---|---|---|---|---|---|
| PIK3CA E545K | breast cancer | sensitive | Ipatasertib + Paclitaxel | Preclinical - Cell line xenograft | Actionable | In a preclinical study, the combination of Ipatasertib (GDC-0068) and Taxol (paclitaxel) inhibited tumor growth in a cell line xenograft model of hormone-receptor positive breast cancer harboring PIK3CA E545K, and demonstrated increased activity over either agent alone (PMID: 32205017). | 32205017 |
| PTEN dec exp | triple-receptor negative breast cancer | predicted - sensitive | Ipatasertib + Paclitaxel | Phase II | Actionable | In a Phase II trial, Ipatasertib (GDC-0068) in combination with Abraxane (paclitaxel) resulted in improved progression free survival (6.2 vs 3.7 months) compared to placebo in triple-receptor negative breast cancer patients with low Pten expression (PMID: 28800861; NCT02162719). | 28800861 |
| PIK3CA act mut | Advanced Solid Tumor | sensitive | Ipatasertib + Paclitaxel | Phase I | Actionable | In a Phase Ib trial, the combination of Ipatasertib (GDC-0068) and Taxol (paclitaxel) resulted in an objective response rate (ORR) of 8.0% (2/25, partial responses) in patients with advanced solid tumors (n=25), and ORR was proportionally higher in patients harboring activating PIK3CA mutations (2/6) compared to patients without PIK3CA activating mutations (0/19) (PMID: 32205017; NCT01362374). | 32205017 |
| PIK3CA act mut | triple-receptor negative breast cancer | no benefit | Ipatasertib + Paclitaxel | Phase III | Actionable | In a Phase III trial (IPATunity 130), the addition of Ipatasertib (GDC-0068) to treatment with Abraxane (paclitaxel) did not result in improved progression-free survival in patients with triple-negative breast cancer harboring PIK3CA and/or AKT activating mutations or PTEN alterations, with a median PFS of 7.4 months with Ipatasertib (GDC-0068) plus Abraxane (paclitaxel) vs. 6.1 months with placebo plus Abraxane (paclitaxel) (SABCS Meeting 2020, Abstract GS3-04; NCT03337724). | detail... |
| PIK3CA act mut | triple-receptor negative breast cancer | no benefit | Ipatasertib + Paclitaxel | Phase II | Actionable | In a Phase II trial (LOTUS), Ipatasertib (GDC-0068) in combination with Abraxane (paclitaxel) resulted a median progression free survival of 6.2 vs 4.9 months with placebo in triple-receptor negative breast cancer patients harboring activating mutations in PIK3CA or AKT1, or inactivating mutations in PTEN (PMID: 28800861; NCT02162719). | 28800861 |
| PTEN inact mut | triple-receptor negative breast cancer | no benefit | Ipatasertib + Paclitaxel | Phase II | Actionable | In a Phase II trial (LOTUS), Ipatasertib (GDC-0068) in combination with Abraxane (paclitaxel) resulted a median progression free survival of 6.2 vs 4.9 months with placebo in triple-receptor negative breast cancer patients harboring activating mutations in PIK3CA or AKT1, or inactivating mutations in PTEN (PMID: 28800861; NCT02162719). | 28800861 |
| PTEN inact mut | triple-receptor negative breast cancer | no benefit | Ipatasertib + Paclitaxel | Phase III | Actionable | In a Phase III trial (IPATunity 130), the addition of Ipatasertib (GDC-0068) to treatment with Abraxane (paclitaxel) did not result in improved progression-free survival in patients with triple-negative breast cancer harboring PIK3CA and/or AKT activating mutations or PTEN alterations, with a median PFS of 7.4 months with Ipatasertib (GDC-0068) plus Abraxane (paclitaxel) vs. 6.1 months with placebo plus Abraxane (paclitaxel) (SABCS 2020, Abstract GS3-04; NCT03337724). | detail... |
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| Clinical Trial | Phase | Therapies | Title | Recruitment Status | Covered Countries | Other Countries |
|---|---|---|---|---|---|---|
| NCT02162719 | Phase II | Ipatasertib + Paclitaxel Paclitaxel | A Study of Ipatasertib (GDC-0068) in Combination With Paclitaxel as Front-line Treatment for Patients With Metastatic Triple-Negative Breast Cancer | Completed | USA | ITA | FRA | ESP | BEL | 3 |
| NCT03337724 | Phase II | Ipatasertib + Paclitaxel Paclitaxel | A Study of Ipatasertib in Combination With Paclitaxel as a Treatment for Participants With PIK3CA/AKT1/PTEN-Altered, Locally Advanced or Metastatic, Triple-Negative Breast Cancer or Hormone Receptor-Positive, HER2-Negative Breast Cancer (IPATunity130) | Completed | USA | TUR | SVN | POL | ITA | HUN | GRC | GBR | FRA | ESP | DEU | CZE | CAN | BRA | BEL | AUS | ARG | 13 |
| NCT04931342 | Phase II | Cobimetinib Ado-trastuzumab emtansine Ipatasertib + Paclitaxel Atezolizumab + Bevacizumab | A Study Evaluating the Efficacy and Safety of Biomarker-Driven Therapies in Patients With Persistent or Recurrent Rare Epithelial Ovarian Tumors | Active, not recruiting | USA | TUR | ITA | GBR | FRA | ESP | DEU | CZE | CHE | CAN | AUS | 2 |
| NCT05554380 | Phase II | Ipatasertib + Paclitaxel | Study of Chemotherapy Plus Ipatasertib for People With Solid Tumors With AKT Mutations, A ComboMATCH Treatment Trial | Recruiting | USA | 1 |
| NCT03498521 | Phase II | Atezolizumab + Paclitaxel Carboplatin Carboplatin + Paclitaxel Olaparib Vismodegib Alectinib Bevacizumab + Erlotinib Cisplatin + Gemcitabine Cobimetinib + Vemurafenib Ipatasertib + Paclitaxel Cisplatin + Paclitaxel Gemcitabine Atezolizumab Entrectinib Pertuzumab + Trastuzumab Paclitaxel + Pertuzumab + Trastuzumab Ipatasertib Carboplatin + Gemcitabine | A Phase II Randomized Study Comparing the Efficacy and Safety of Targeted Therapy or Cancer Immunotherapy Versus Platinum-Based Chemotherapy in Patients With Cancer of Unknown Primary Site (CUPISCO) | Active, not recruiting | TUR | ROU | POL | NOR | NLD | LVA | ITA | ISR | IRL | HUN | HRV | GRC | GBR | FRA | FIN | EST | ESP | DNK | DEU | CZE | CHE | BRA | BGR | AUT | AUS | 8 |
| NCT05564377 | Phase II | Selumetinib Binimetinib + Fulvestrant Binimetinib + Palbociclib Nilotinib + Paclitaxel Binimetinib + Fluorouracil + Leucovorin + Oxaliplatin Panitumumab + Sotorasib Binimetinib Fulvestrant Olaparib Olaparib + Selumetinib Alpelisib + Olaparib Neratinib Neratinib + Palbociclib Fluorouracil + Leucovorin + Oxaliplatin Ipatasertib + Paclitaxel | Targeted Therapy Directed by Genetic Testing in Treating Patients With Locally Advanced or Advanced Solid Tumors, The ComboMATCH Screening Trial | Recruiting | USA | 1 |
| NCT04177108 | Phase III | Ipatasertib + Paclitaxel Atezolizumab + Paclitaxel Atezolizumab + Ipatasertib + Paclitaxel Paclitaxel | A Study Of Ipatasertib in Combination With Atezolizumab and Paclitaxel as a Treatment for Participants With Locally Advanced or Metastatic Triple-Negative Breast Cancer. | Completed | USA | TUR | ROU | POL | NZL | ITA | ISR | GRC | GBR | FRA | FIN | ESP | DNK | CZE | CHE | CAN | BRA | BGR | BEL | AUT | AUS | ARG | 15 |
| NCT04561817 | Phase II | Ipatasertib + Paclitaxel | To Evaluate the Safety and Efficacy of Ipatasertib (GDC-0068) in Combination With Paclitaxel in Platinum-resistant Recurrent Epithelial Ovarian Cancer | Withdrawn | USA | 0 |
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