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) 18 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 12 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 mutant 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 4.9 months) compared to placebo in triple-receptor negative breast cancer patients harboring mutations in PIK3CA, AKT1, or PTEN (J Clin Oncol 35, 2017 (suppl; abstr 1009)). detail...
AKT1 mutant 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 4.9 months) compared to placebo in triple-receptor negative breast cancer patients harboring mutations in PIK3CA, AKT1, or PTEN (J Clin Oncol 35, 2017 (suppl; abstr 1009)). detail...
Unknown unknown triple-receptor negative breast cancer not applicable 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 4.9 months) compared to placebo in patients with triple-receptor negative breast cancer (PMID: 28800861; NCT02162719). 28800861 detail...
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) synergistically inhibited tumor growth in cell line xenograft models of breast cancer cells harboring PIK3CA E545K (PMID: 32205017). 32205017
Unknown unknown Advanced Solid Tumor not applicable Ipatasertib + Paclitaxel Phase I Actionable In a Phase Ib trial, the combination of Ipatasertib (GDC-0068) and Taxol (paclitaxel) demonstrated safety in patients with advanced solid tumors, and resulted in an overall response rate of 8.0% (2/25), including partial responses in two patients, stable disease in 56.0% (14/25) of patients, a six-month progression-free survival rate of 12.0% (3/25), and maximum progression-free survival duration of 14 months in a breast cancer patient (PMID: 32205017; NCT01362374). 32205017
PIK3CA act mut Advanced Solid Tumor sensitive Ipatasertib + Paclitaxel Phase Ib/II Actionable In a Phase Ib trial, Ipatasertib (GDC-0068) in combination with Abraxane (paclitaxel) demonstrated safety and anti-tumor activity in patients with advanced solid tumors, including patients with PIK3CA activating mutations (Annals of Oncology (2014) 25 (suppl_4): iv146-iv164. 10.1093/annonc/mdu331). detail...

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Clinical Trial Phase Therapies Title Recruitment Status
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) Recruiting
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. Recruiting
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


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