Therapy Detail

Therapy Name Guadecitabine
Synonym
Therapy Description

Guadecitabine (SGI-110) is a dinucleotide comprised of decitabine and deoxyguanosine, which inhibits DNA methylation, potentially resulting in decreased tumor cell growth (PMID: 20442312, PMID: 17616700).

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Drug Name Trade Name Synonyms Drug Classes Drug Description
Guadecitabine S110|DNMT inhibitor SGI-110 DNMT inhibitor (Pan) 5 Guadecitabine (SGI-110) is a dinucleotide comprised of decitabine and deoxyguanosine, which inhibits DNA methylation, potentially resulting in decreased tumor cell growth (PMID: 20442312, PMID: 17616700).
Molecular Profile Indication/Tumor Type Response Type Therapy Name Approval Status Evidence Type Efficacy Evidence References
Unknown unknown myelodysplastic syndrome not applicable Guadecitabine Phase I Actionable In a Phase I trial, SGI-110 treatment resulted in clinical response in 32% (6/19) of patients with myelodysplastic syndrome (PMID: 26296954). 26296954
Unknown unknown acute myeloid leukemia not applicable Guadecitabine Phase I Actionable In a Phase I trial, SGI-110 treatment resulted in clinical response in 8% (6/74) of patients with acute myeloid leukemia (PMID: 26296954). 26296954
Clinical Trial Phase Therapies Title Recruitment Status
NCT02907359 Phase III Cytarabine Guadecitabine Guadecitabine (SGI-110) vs Treatment Choice in Adults With MDS or CMML Previously Treated With HMAs Active, not recruiting
NCT02684162 Phase II Guadecitabine SGI-110 With Donor Lymphocyte Infusion (DLI) for Acute Myelogenous Leukemia (AML) or Myelodysplastic Syndrome (MDS) Relapsing Post Allogeneic Stem Cell Transplantation (AlloSCT) Recruiting
NCT02131597 Phase II Guadecitabine SGI-110 in Higher Risk Myelodysplastic Syndrome (MDS) Recruiting
NCT02429466 Phase I Cisplatin Guadecitabine Study of the Hypomethylating Drug SGI-110 Plus Cisplatin in Relapsed Refractory Germ Cell Tumors Suspended
NCT02096055 Phase II Cladribine Guadecitabine Idarubicin 4-Arm Phase II Study of SGI-110 in Elderly Acute Myeloid Leukemia (AML) Active, not recruiting
NCT02920008 Phase III Decitabine Azacitidine Cytarabine Guadecitabine Phase 3 Randomized, Open-Label Study of Guadecitabine vs Treatment Choice in Previously Treated Acute Myeloid Leukemia Active, not recruiting
NCT02348489 Phase III Guadecitabine Cytarabine Azacitidine Decitabine SGI-110 in Adults With Untreated Acute Myeloid Leukemia (AML), Not Considered Candidates for Intensive Remission Induction Completed
NCT03308396 Phase Ib/II Durvalumab + Guadecitabine Guadecitabine Study of Durvalumab and Guadecitabine in Advanced Kidney Cancer Recruiting
NCT03165721 Phase II Guadecitabine A Phase II Trial of the DNA Methyl Transferase Inhibitor, Guadecitabine (SGI-110), in Children and Adults With Wild Type GIST,Pheochromocytoma and Paraganglioma Associated With Succinate Dehydrogenase Deficiency and HLRCC-associated Kidney Cancer Recruiting
NCT01966289 Phase I Cyclophosphamide Guadecitabine GVAX colorectal cancer vaccine SGI-110 in Combination With an Allogeneic Colon Cancer Cell Vaccine (GVAX) and Cyclophosphamide (CY) in Metastatic Colorectal Cancer (mCRC) Active, not recruiting
NCT03075826 Phase II Guadecitabine A Phase II Study of SGI-110 in Philadelphia-Negative Myeloproliferative Neoplasms Recruiting
NCT03603964 Phase II Guadecitabine Guadecitabine Extension Study Not yet recruiting