Drugs / Guadecitabine
last change 3 days ago re-read 2 minutes ago

Guadecitabine

Oligonucleotide (other)

Developed for
acute myeloid leukemia · myelodysplastic syndrome · chronic myelomonocytic leukemia · fallopian tube carcinoma · hepatocellular carcinoma · non-small cell lung carcinoma · ovarian carcinoma · primary peritoneal carcinoma
+20 more · small cell lung carcinoma · clear cell renal carcinoma · colorectal adenocarcinoma · colorectal cancer · gallbladder adenocarcinoma · gastrointestinal stromal tumor · germ cell tumor · intrahepatic cholangiocarcinoma · localized chondrosarcoma · lung cancer · melanoma · metastatic melanoma · myeloproliferative neoplasm · ovarian cancer · pancreatic adenocarcinoma · paraganglioma · pheochromocytoma · renal cell carcinoma · testicular cancer · urothelial carcinoma
Investigated by
Astex Pharmaceuticals, Inc. · National Cancer Institute (NCI) · Van Andel Research Institute · M.D. Anderson Cancer Center · Merck Sharp & Dohme LLC · University of Southern California
+23 more · Bristol-Myers Squibb · Groupe Francophone des Myelodysplasies · Italian Network for Tumor Biotherapy Foundation · Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins · Stand Up To Cancer · Ajjai Alva, MD · Astex Therapeutics, Ltd · AstraZeneca · Big Ten Cancer Research Consortium · Catherine Shu · Fox Chase Cancer Center · Hoffmann-La Roche · Indiana University · Institute of Cancer Research, United Kingdom · Memorial Sloan Kettering Cancer Center · Mirati Therapeutics Inc. · Nasser Hanna · Northwestern University · Otsuka Pharmaceutical Co., Ltd. · Royal Marsden NHS Foundation Trust · Shadia Jalal, MD · Susan Cohan Colon Cancer Foundation · Weill Medical College of Cornell University

Trials 33 · a red edge is where a trial was stopped

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 19 trials
Phase 1 NCT03257761 Feb 2018 → Sep 2021 overdue gallbladder adenocarcinoma, hepatocellular carcinoma, intrahepatic cholangiocarcinoma, pancreatic adenocarcinoma University of Southern California Active not recruiting No outcome recorded
Phase 1 NCT03085849 Dec 2017 → Nov 2018 small cell lung carcinoma Catherine Shu Completed No outcome recorded
Phase 1 NCT03220477 Aug 2017 → Jul 2026 overdue lung cancer Memorial Sloan Kettering Cancer Center Active not recruiting No outcome recorded
Phase 1 NCT02998567 Jan 2017 → Sep 2026 expected non-small cell lung carcinoma Royal Marsden NHS Foundation Trust Active not recruiting No outcome recorded
Phase 1 NCT02892318 Oct 2016 → Dec 2019 acute myeloid leukemia Hoffmann-La Roche Completed No outcome recorded
Phase 1 NCT02608437 Oct 2015 → Oct 2016 metastatic melanoma Italian Network for Tumor Biotherapy Foundation Unknown No outcome recorded
Phase 1 NCT02429466 Apr 2015 → Jun 2018 germ cell tumor, testicular cancer Nasser Hanna Completed No outcome recorded
Phase 1 NCT02293993 Jan 2015 → Jun 2017 acute myeloid leukemia Otsuka Pharmaceutical Co., Ltd. Completed No outcome recorded
Phase 1 NCT01966289 Apr 2014 → Jun 2020 colorectal cancer Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Completed No outcome recorded
Phase 1/26 trials
Phase 1/2 NCT03576963 Jan 2020 → Jan 2022 colorectal adenocarcinoma University of Southern California Withdrawn No outcome recorded
Phase 1/2 NCT03308396 Dec 2017 → Dec 2022 overdue clear cell renal carcinoma Ajjai Alva, MD Active not recruiting No outcome recorded
Phase 1/2 NCT03206047 Nov 2017 → Nov 2020 fallopian tube carcinoma, ovarian carcinoma, primary peritoneal carcinoma National Cancer Institute (NCI) Completed No outcome recorded
Phase 1/2 NCT02935361 Nov 2016 → Jun 2027 expected acute myeloid leukemia, chronic myelomonocytic leukemia, myelodysplastic syndrome University of Southern California Active not recruiting No outcome recorded
Phase 1/2 NCT01896856 Oct 2013 → Aug 2019 Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Completed No outcome recorded
Phase 1/2 NCT01261312 Jan 2011 → Jul 2016 acute myeloid leukemia, chronic myelomonocytic leukemia, myelodysplastic syndrome Astex Pharmaceuticals, Inc. Completed No outcome recorded
Phase 215 trials
Phase 2 NCT04340843 Sep 2020 → Feb 2024 overdue localized chondrosarcoma National Cancer Institute (NCI) Active not recruiting No outcome recorded
Phase 2 NCT04250246 Mar 2020 → Mar 2023 melanoma, non-small cell lung carcinoma Italian Network for Tumor Biotherapy Foundation Unknown No outcome recorded
Phase 2 NCT03913455 Jun 2019 → Apr 2021 small cell lung carcinoma Shadia Jalal, MD Completed No outcome recorded
Phase 2 NCT03454984 Nov 2018 → Sep 2020 acute myeloid leukemia, myelodysplastic syndrome Groupe Francophone des Myelodysplasies Unknown No outcome recorded
Phase 2 NCT03603964 Jul 2018 → Oct 2021 acute myeloid leukemia, myelodysplastic syndrome Astex Pharmaceuticals, Inc. Terminated No outcome recorded
Phase 2 NCT03179943 Nov 2017 → Jul 2020 overdue urothelial carcinoma Fox Chase Cancer Center Active not recruiting No outcome recorded
Phase 2 NCT03165721 Aug 2017 → Feb 2020 gastrointestinal stromal tumor, paraganglioma, pheochromocytoma, renal cell carcinoma National Cancer Institute (NCI) Terminated No outcome recorded
Phase 2 NCT02901899 Nov 2016 → Apr 2020 fallopian tube carcinoma, ovarian carcinoma, primary peritoneal carcinoma Northwestern University Completed No outcome recorded
Phase 2 NCT02684162 Jun 2016 → Oct 2024 acute myeloid leukemia, chronic myelomonocytic leukemia, myelodysplastic syndrome M.D. Anderson Cancer Center Completed No outcome recorded
Phase 2 NCT03075826 Mar 2016 → Mar 2021 myeloproliferative neoplasm Weill Medical College of Cornell University Completed No outcome recorded
Phase 33 trials
Phase 3 NCT02920008 Mar 2017 → Jan 2020 acute myeloid leukemia Astex Pharmaceuticals, Inc. Completed No outcome recorded
Phase 3 NCT02907359 Jan 2017 → Mar 2020 chronic myelomonocytic leukemia, myelodysplastic syndrome Astex Pharmaceuticals, Inc. Completed No outcome recorded
Phase 3 NCT02348489 Mar 2015 → May 2018 acute myeloid leukemia Astex Pharmaceuticals, Inc. Completed No outcome recorded

Press releases naming this drug 3 releases

DateIssuerRelease
2020-10-15 Otsuka Pharmaceutical Development & Commercialization, Inc. Otsuka and its subsidiary Astex announce results of phase 3, ASTRAL-2 and ASTRAL-3 trials of guadecitabine in patients with previously treated AML and MDS/CMML otsuka.co.jp
2018-07-31 Otsuka Pharmaceutical Development & Commercialization, Inc. Otsuka and Astex announce results of the phase 3 ASTRAL-1 study of guadecitabine (SGI-110) in treatment-naïve AML patients ineligible to receive intense induction chemotherapy otsuka.co.jp
2016-04-20 Otsuka Pharmaceutical Development & Commercialization, Inc. Otsuka's U.S. Subsidiary Astex Pharmaceuticals Enters Clinical Trial Collaboration to Explore the Potential of Combining Guadecitabine (SGI-110) with Atezolizumab in the Treatment of Acute Myeloid Leukemia otsuka.co.jp

Evidence & citations 11 cited values

Every value below carries the sentence it was read from. 36 sources stand behind the page.

FieldValueCited text
Known as Guadecitabine ClinicalTrials.gov intervention name — accepted as the source's own label NCT02907359
22

NCT02348489

NCT02901899

NCT02429466

NCT04340843

NCT04250246

NCT02892318

NCT02920008

NCT02684162

NCT03454984

NCT03308396

NCT02096055

NCT01261312

NCT03603964

NCT03913455

NCT02998567

NCT03220477

NCT03576963

NCT02131597

NCT03206047

NCT03179943

NCT02935361

NCT03257761

Known as Guadecitabina ChEMBL registry synonym — accepted as the source's own label CHEMBL3544916
Known as guadecitabine (SGI-110) guadecitabine (SGI-110)NCT04250246
Known as GUADECITABINE SODIUM ChEMBL registry synonym — accepted as the source's own label CHEMBL3544916
Known as S110 sodium salt ChEMBL registry synonym — accepted as the source's own label CHEMBL3544916
Known as SGI-110 “A Phase Ib Study of Guadecitabine (SGI-110) and Durvalumab (MEDI 4736) in Patients With Advanced Hepatocellular Carcinoma, Pancreatic Adenocarcinoma, and...” NCT03257761
14

“Guadecitabine (SGI-110) is a novel hypomethylating dinucleotide of Decitabine and deoxyguanosine resistant to degradation by cytidine deaminase.” NCT03454984

“Study of the Hypomethylating Drug Guadecitabine (SGI-110) Plus Cisplatin in Relapsed Refractory Germ Cell Tumors” NCT02429466

“Guadecitabine (SGI-110)/ASTX727 a Second Generation Hypo-Methylating Agent” NCT02998567

SGI-110 (guadecitabine)” NCT02348489

NCT03085849

NCT01752933

NCT01696032

NCT01966289

NCT02608437

NCT01896856

NCT02293993

NCT02197676

NCT03165721

NCT03075826

Known as Sgi-110 free acid ChEMBL registry synonym — accepted as the source's own label CHEMBL3544916
Known as SGI-110 sodium salt ChEMBL registry synonym — accepted as the source's own label CHEMBL3544916
Action Inhibit “Guadecitabine is a novel DNA methyltransferase (DNMT) inhibitor” PMID 31331399 Jul 2019
Modality Oligonucleotide (other) “Guadecitabine (SGI-110) is a novel hypomethylating dinucleotide of decitabine and deoxyguanosine resistant to degradation by cytidine deaminase.” PMID 26296954 Aug 2015
Route Subcutaneous subcutaneously given guadecitabine” PMID 26296954 Aug 2015