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| Therapy Name | CPI-613 + Fluorouracil + Irinotecan + Leucovorin + Oxaliplatin |
| Synonyms | CPI-613 + FOLFIRINOX |
| Therapy Description | |
| Drug Name | Trade Name | Synonyms | Drug Classes | Drug Description |
|---|---|---|---|---|
| CPI-613 | CPI613|CPI 613|Devimistat | Devimistat (CPI-613) is an inhibitor of pyruvate dehydrogenase (PDH) and alpha-ketogluterate (KGDH), resulting in blockade of mitochondrial respiration which may lead to apoptosis and death of cancer cells (PMID: 29437791, PMID: 28495639, PMID: 32789692, PMID: 31512500). | ||
| Fluorouracil | Adrucil | 5-FU|5-Fluorouracil | Chemotherapy - Antimetabolite 14 | Adrucil (fluorouracil) is an antimetabolite chemotherapeutic agent that interferes with DNA and RNA synthesis, thereby preventing cancer cell growth (PMID: 28520376). Adrucil (fluorouracil) is FDA-approved for use in patients with adenocarcinoma of the colon, rectum, breast, stomach, and pancreas (FDA.gov). |
| Irinotecan | Camptosar | CPT-11 | TOPO1 inhibitor 11 | Camptosar (irinotecan) inhibits Topoisomerase-I activity, resulting in inhibition of DNA replication, and potentially leading to cell death and is indicated as a component of first-line therapy in combination with 5-fluorouracil and leucovorin for patients with metastatic or recurrent colorectal carcinoma (FDA.gov). |
| 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). |
| Molecular Profile | Indication/Tumor Type | Response Type | Therapy Name | Approval Status | Evidence Type | Efficacy Evidence | References |
|---|
| Clinical Trial | Phase | Therapies | Title | Recruitment Status | Covered Countries | Other Countries |
|---|---|---|---|---|---|---|
| NCT03504423 | Phase III | CPI-613 CPI-613 + Fluorouracil + Irinotecan + Leucovorin + Oxaliplatin | Study Evaluating Efficacy and Safety of FFX Versus Combination of CPI-613 With mFFX in Patients With Metastatic Adenocarcinoma of the Pancreas | Completed | USA | ISR | FRA | DEU | BEL | 1 |
| NCT05926206 | Phase Ib/II | CPI-613 + Fluorouracil + Irinotecan + Leucovorin + Oxaliplatin | Trial of Devimistat in Combination With Modified FOLFIRINOX in Patients With Metastatic Adenocarcinoma of the Pancreas | Withdrawn | USA | 0 |
| NCT03699319 | Phase II | CPI-613 + Fluorouracil + Irinotecan + Leucovorin + Oxaliplatin | CPI-613 in Combination With Modified FOLFIRINOX in Locally Advanced Pancreatic Cancer | Completed | USA | 0 |
| NCT03374852 | Phase II | CPI-613 + Fluorouracil + Irinotecan + Leucovorin + Oxaliplatin | CPI-613 in Combination With Modified FOLFIRINOX in Patients With Locally Advanced Pancreatic Cancer | Withdrawn | 0 |