Therapy Detail
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| Therapy Name | Fluorouracil + Ipatasertib + Leucovorin + Oxaliplatin |
| Synonyms | Ipatasertib + mFOLFOX6|Ipataserib + FOLFOX |
| Therapy Description | |
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| Drug Name | Trade Name | Synonyms | Drug Classes | Drug Description |
|---|---|---|---|---|
| Fluorouracil | Adrucil | 5-FU|5-Fluorouracil | Chemotherapy - Antimetabolite 14 | Adrucil (fluorouracil) is an antimetabolite chemotherapeutic agent, which interferes with DNA and RNA synthesis thereby preventing cancer cell growth and is FDA approved for colorectal, breast, stomach, and pancreatic cancer (FDA.gov). |
| 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). | |
| Leucovorin | Wellcovorin | Calcium folinate|Calcium citrovorum factor|folinic acid | Chemotherapy - Antimetabolite 14 | Wellcovorin (leucovorin) is a metabolite of folate that enhances the efficacy of fluoruracil (PMID: 32490554). |
| Oxaliplatin | Eloxatin | Diaminocyclohexane Oxalatoplatinum | Chemotherapy - Platinum 7 | Eloxatin (oxaliplatin) is comprised of a platinum complex, which causes DNA-platinum cross-links, inhibition of DNA replication and transcription, and cell toxicity, and is FDA approved for colorectal cancer (FDA.gov). |
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| Molecular Profile | Indication/Tumor Type | Response Type | Therapy Name | Approval Status | Evidence Type | Efficacy Evidence | References |
|---|---|---|---|---|---|---|---|
| PIK3CA act mut | Advanced Solid Tumor | predicted - sensitive | Fluorouracil + Ipatasertib + Leucovorin + Oxaliplatin | Phase I | Actionable | In a Phase Ib trial, the combination of Ipatasertib (GDC-0068) and mFOLFOX6 resulted in an objective response rate (ORR) of 6.1% (2/33, partial responses) in patients with advanced solid tumors (n=33), and ORR was proportionally higher in patients harboring activating PIK3CA mutations (1/4) compared to in patients without PIK3CA activating mutations (1/29) (PMID: 32205017; NCT01362374). | 32205017 |
| PTEN dec exp | stomach cancer | no benefit | Fluorouracil + Ipatasertib + Leucovorin + Oxaliplatin | Phase II | Actionable | In a Phase II trial, the combination of Ipatasertib (GDC-0068) and mFOLFOX6 did not improve median progression-free survival (7.1 vs 7.4 months; HR=1.07, p=0.86) compared to placebo plus mFOLFOX6 in patients with advanced gastric or gastroesophageal junction cancer harboring decreased PTEN expression (IHC=0 in >10% of tumor cells) (PMID: 30592991; NCT01896531). | 30592991 |
| PTEN loss | stomach cancer | sensitive | Fluorouracil + Ipatasertib + Leucovorin + Oxaliplatin | Preclinical - Pdx | Actionable | In a preclinical study, the combination of Ipatasertib (GDC-0068) and FOLFOX inhibited tumor growth in a patient-derived xenograft (PDX) model of ERBB2 (HER2)-negative gastric cancer harboring PTEN loss, and demonstrated increased activity over either agent alone (PMID: 32205017). | 32205017 |
| PTEN dec exp | gastroesophageal cancer | no benefit | Fluorouracil + Ipatasertib + Leucovorin + Oxaliplatin | Phase II | Actionable | In a Phase II trial, the combination of Ipatasertib (GDC-0068) and mFOLFOX6 did not improve median progression-free survival (7.1 vs 7.4 months; HR=1.07, p=0.86) compared to placebo plus mFOLFOX6 in patients with advanced gastroesophageal junction or gastric cancer harboring decreased PTEN expression (IHC=0 in >10% of tumor cells) (PMID: 30592991; NCT01896531). | 30592991 |
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| Clinical Trial | Phase | Therapies | Title | Recruitment Status | Covered Countries | Other Countries |
|---|
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