Therapy Detail

Therapy Name Guadecitabine
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 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
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
Clinical Trial Phase Therapies Title Recruitment Status
NCT02429466 Phase I Cisplatin Guadecitabine Study of the Hypomethylating Drug SGI-110 Plus Cisplatin in Relapsed Refractory Germ Cell Tumors Suspended
NCT03075826 Phase II Guadecitabine A Phase II Study of SGI-110 in Philadelphia-Negative Myeloproliferative Neoplasms Recruiting
NCT03308396 Phase Ib/II Durvalumab + Guadecitabine Guadecitabine Study of Durvalumab and Guadecitabine in Advanced Kidney Cancer 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
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
NCT02096055 Phase II Cladribine Guadecitabine Idarubicin 4-Arm Phase II Study of SGI-110 in Elderly Acute Myeloid Leukemia (AML) Active, not recruiting
NCT02907359 Phase III Cytarabine Guadecitabine Guadecitabine (SGI-110) vs Treatment Choice in Adults With MDS or CMML Previously Treated With HMAs 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
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
NCT02131597 Phase II Guadecitabine SGI-110 in Higher Risk Myelodysplastic Syndrome (MDS) Recruiting