Therapy Detail

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Therapy Name Fluorouracil
Synonyms
Therapy Description

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).

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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).

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Molecular Profile Indication/Tumor Type Response Type Therapy Name Approval Status Evidence Type Efficacy Evidence References

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Clinical Trial Phase Therapies Title Recruitment Status Covered Countries Other Countries
NCT01358877 Phase III Pertuzumab Epirubicin Cyclophosphamide Paclitaxel Docetaxel Trastuzumab Fluorouracil Carboplatin Doxorubicin A Study of Pertuzumab in Addition to Chemotherapy and Trastuzumab as Adjuvant Therapy in Participants With Human Epidermal Growth Receptor 2 (HER2)-Positive Primary Breast Cancer (APHINITY) Active, not recruiting USA | SWE | SVN | ROU | POL | NZL | NLD | ITA | ISR | IRL | HUN | HRV | GBR | FRA | ESP | DNK | DEU | CZE | CHE | CAN | BGR | BEL | AUT | AUS | ARG 17
NCT03512756 Phase II Methoxsalen + Phenytoin + Sirolimus + SM88 Gemcitabine Fluorouracil Capecitabine A Multi-Center Study of SM-88 in Subjects With Pancreatic Cancer Terminated USA 0
NCT03721744 Phase II Gemcitabine + Napabucasin + Paclitaxel Fluorouracil + Liposomal irinotecan Gemcitabine Fluorouracil Capecitabine A Study of GB201 in Combination With Weekly Paclitaxel and Low-dose Gemcitabine in Patients With Pancreatic Cancer Recruiting FRA | ESP 1
NCT02083653 Phase II SYM004 Fluorouracil Capecitabine Sym004 vs Standard of Care in Subjects With Metastatic Colorectal Cancer Completed USA | POL | ITA | HUN | FRA | ESP | DEU | BEL | AUT 1
NCT01750918 Phase II Fluorouracil Dabrafenib + Panitumumab Dabrafenib + Panitumumab + Trametinib Panitumumab + Trametinib BRAF/MEK/EGFR Inhibitor Combination Study in Colorectal Cancer (CRC) Completed USA | NLD | ITA | GBR | FRA | ESP | BEL 1
NCT01775501 Phase II Sorafenib Fluorouracil Oxaliplatin Leucovorin Sorafenib + mFOLFOX for Hepatocellular Carcinoma Completed USA 0
NCT03783442 Phase III Cisplatin Paclitaxel Tislelizumab Oxaliplatin Fluorouracil Capecitabine A Study of Tislelizumab (BGB-A317) in Combination With Chemotherapy as First Line Treatment in Participants With Advanced Esophageal Squamous Cell Carcinoma Completed USA | ROU | POL | ITA | GBR | FRA | ESP | DEU | CZE | BEL | AUS 5
NCT06490536 Phase III Fluorouracil + Leucovorin + Oxaliplatin Ipilimumab + Nivolumab Irinotecan + Temozolomide Fluorouracil + Leucovorin Capecitabine Fluorouracil + Irinotecan + Leucovorin Fluorouracil Capecitabine + Oxaliplatin The Sagittarius Trial Recruiting ITA | ESP 0
NCT05704985 Phase I DK210 DK210 + Nivolumab Paclitaxel DK210 + Pembrolizumab Oxaliplatin Capecitabine Fluorouracil Carboplatin Evaluating Safety and Biomarkers Using DK210 (EGFR) for Locally Advanced or Metastatic EGFR+ Tumors Recruiting USA 0
NCT03088059 Phase II Niraparib Durvalumab + Monalizumab Methotrexate Carboplatin Rogaratinib Mitomycin C Docetaxel Afatinib Paclitaxel Durvalumab Monalizumab Palbociclib Bleomycin Gemcitabine Fluorouracil Biomarker-based Study in R/M SCCHN (UPSTREAM) Active, not recruiting ITA | GBR | FRA | ESP | BEL 0
NCT03387111 Phase Ib/II Capecitabine Nab-paclitaxel Leucovorin GI-6301 GI-6207 Avelumab ETBX-021 ETBX-051 ETBX-061 Aldoxorubicin Cisplatin Cyclophosphamide Bevacizumab Necitumumab GI-4000 Cetuximab Nogapendekin alfa inbakicept Fluorouracil ETBX-011 Molecularly Informed Integrated Immunotherapy Combining Innate haNK Cell Therapy With Adenoviral and Yeast-based Vaccines to Induce T-cell Responses in Subjects With SCC Who Have Progressed on or After Platinum-based Chemotherapy and Anti- PD-1/ PD-L1 Therapy Terminated USA 0
NCT01099358 Phase II Cetuximab + Cisplatin Fluorouracil Study in Advanced Solid Tumors Completed USA | CAN 0
NCT03387085 Phase Ib/II ETBX-051 Aldoxorubicin ETBX-061 Cisplatin Cyclophosphamide haNK cells GI-4000 Bevacizumab Nogapendekin alfa inbakicept Fluorouracil ETBX-011 Oxaliplatin Capecitabine Leucovorin GI-6301 Nab-paclitaxel Avelumab GI-6207 QUILT-3.067: NANT Triple Negative Breast Cancer (TNBC) Vaccine: Molecularly Informed Integrated Immunotherapy in Subjects With TNBC Who Have Progressed on or After Standard-of-care Therapy. Terminated USA 0
NCT03136406 Phase Ib/II GI-4000 Leucovorin Avelumab Nab-paclitaxel Bevacizumab Cyclophosphamide Capecitabine Oxaliplatin Fluorouracil ETBX-011 Nogapendekin alfa inbakicept QUILT-3.039: NANT Pancreatic Cancer Vaccine: Combination Immunotherapy in Subjects With Pancreatic Cancer Who Have Progressed on or After Standard-of-care Therapy Terminated USA 0
NCT05200988 Phase II Mitomycin C Ipilimumab + Nivolumab Capecitabine Fluorouracil Checkpoint Inhibition and Chemoradiotherapy as Bladder Sparing Treatment in UC (Indi-Blade) Active, not recruiting NLD 0
NCT02138617 Phase II Leucovorin Bevacizumab Irinotecan Fluorouracil Genotype-Directed Study Of Irinotecan Dosing In FOLFIRI + BevacizumabTreated Metastatic Colorectal Cancer Active, not recruiting USA 0
NCT03387098 Phase Ib/II GI-4000 Leucovorin Nab-paclitaxel Bevacizumab Avelumab Nogapendekin alfa inbakicept Fluorouracil ETBX-011 Oxaliplatin Aldoxorubicin Capecitabine Cyclophosphamide QUILT-3.070: Molecularly Informed Integrated Immunotherapy Combining Innate High-affinity Natural Killer (haNK) Cell Therapy With Adenoviral and Yeast-based Vaccines to Induce T-cell Responses in Subjects With Pancreatic Cancer Who Have Progressed on or After Standard-of-care Therapy Terminated USA 0
NCT02788201 Phase II Erlotinib Thiotepa Imatinib Dacarbazine Arsenic trioxide Idarubicin Mitomycin C Thioguanine Mercaptopurine Methotrexate Cladribine Epirubicin Gemcitabine Doxorubicin Bleomycin Etoposide Gefitinib Daunorubicin Lomustine Sorafenib Sunitinib Ifosfamide Asparaginase Ixabepilone Abiraterone Azacitidine Ruxolitinib Decitabine Axitinib Estramustine Floxuridine Lapatinib Carmustine Fludarabine Nilotinib Cisplatin Vismodegib Vandetanib Melphalan Busulfan Carboplatin Toremifene Crizotinib Dactinomycin Temsirolimus Vorinostat Romidepsin Fluorouracil Irinotecan Bortezomib Tamoxifen Topotecan Chlorambucil Pentostatin Eribulin Carfilzomib Vemurafenib Hydroxyurea Exemestane Vincristine Sulfate Dasatinib Mitoxantrone Vinblastine Cytarabine Tretinoin Clofarabine Teniposide Docetaxel Pazopanib Oxaliplatin Streptozocin Paclitaxel Bendamustine Mechlorethamine Mitotane Genomic Based Assignment of Therapy in Advanced Urothelial Carcinoma Completed USA 0
NCT04241185 Phase III Pembrolizumab Cisplatin Mitomycin C Gemcitabine Fluorouracil Efficacy and Safety of Pembrolizumab (MK-3475) in Combination With Chemoradiotherapy (CRT) Versus CRT Alone in Muscle-invasive Bladder Cancer (MIBC) (MK-3475-992/KEYNOTE-992) Active, not recruiting USA | TUR | ROU | POL | NLD | LVA | ITA | ISR | HUN | GBR | FRA | EST | ESP | DNK | CZE | AUS 8
NCT01128387 Phase Ib/II Fluorouracil Panitumumab Cisplatin Trial of Panitumumab/Cisplatin/Fluorouracil With XRT in Esophageal Cancer Terminated USA 0
NCT06646445 Phase II Pembrolizumab Capecitabine + Oxaliplatin Capecitabine Fluorouracil Fluorouracil + Oxaliplatin Neoadjuvant Pembrolizumab with a Watch-and-wait Strategy for Patients with DMMR/MSI-H Localized Colon Cancer: GERCOR G-109 PRODIGE 84 PREMICES Phase II Trial (PREMICES) Not yet recruiting FRA 0
NCT02688712 Phase II Capecitabine + Galunisertib Fluorouracil + Galunisertib Galunisertib Fluorouracil Capecitabine ExIST Study of LY2157299 (Galunisertib) in Rectal Cancer Active, not recruiting USA 0
NCT04329221 Phase II Fluorouracil Calcipotriene + Fluorouracil Immunotherapy Before Transplantation for Skin Cancer Prevention in Organ Transplant Recipients Not yet recruiting USA 0
NCT03127007 Phase Ib/II Fluorouracil Atezolizumab + Fluorouracil Safety and Efficacy of Atezolizumab Combined to Preoperative Radio-chemotherapy in Localized Rectal Cancer (R-IMMUNE) Active, not recruiting BEL 0
NCT02314117 Phase III Capecitabine Fluorouracil Cisplatin Ramucirumab A Study of Ramucirumab (LY3009806) in Combination With Capecitabine and Cisplatin in Participants With Stomach Cancer Completed USA | POL | NLD | ITA | ISR | HUN | GBR | FRA | FIN | ESP | DNK | DEU | CZE | CAN | BEL | ARG 4
NCT02358031 Phase III Cetuximab Pembrolizumab Fluorouracil Carboplatin Cisplatin A Study of Pembrolizumab (MK-3475) for First Line Treatment of Recurrent or Metastatic Squamous Cell Cancer of the Head and Neck (MK-3475-048/KEYNOTE-048) Completed 0
NCT02620423 Phase I Gemcitabine Fluorouracil Irinotecan Pelareorep Leucovorin Pembrolizumab Study of Pembrolizumab With REOLYSIN and Chemotherapy in Patients With Advanced Pancreatic Adenocarcinoma Completed USA 0
NCT03878524 Phase I Oxaliplatin Palbociclib Vemurafenib Sirolimus Tretinoin Celecoxib Ipilimumab Ruxolitinib Dasatinib Abiraterone Idelalisib Trametinib Imatinib Erlotinib Carboplatin Olaparib Panobinostat Bortezomib Afatinib Fluorouracil Vorinostat Pembrolizumab Leucovorin Enzalutamide Ponatinib Nivolumab Everolimus Sunitinib Cabazitaxel Cabozantinib Lenvatinib Pertuzumab Sorafenib Venetoclax Bevacizumab A Personalized Medicine Study for Patients With Advanced Cancer of the Breast, Prostate, Pancreas or Those With Refractory Acute Myelogenous Leukemia (SMMART) Terminated USA 0


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