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
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 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
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
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...
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
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
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...

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Clinical Trial Phase Therapies Title Recruitment Status Covered Countries Other Countries
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 | ITA | GBR | FRA | ESP | CAN | BEL | AUT | AUS 28
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 Recruiting USA | ITA | GBR | FRA | ESP | DEU | CAN | BEL | AUS 5
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
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 ITA | GBR | FRA | ESP | DEU | AUT | AUS 26
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 | ITA | GBR | FRA | ESP | DEU | CAN | BEL | AUS 21
NCT05554380 Phase II Ipatasertib + Paclitaxel Study of Chemotherapy Plus Ipatasertib for People With Solid Tumors With AKT Mutations, A ComboMATCH Treatment Trial Recruiting USA 0
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
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


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