Guadecitabine Extension Study

Stopped early · Phase 2

Conditions studied: Acute Myeloid Leukemia, Myeloid Dysplastic Syndrome

In brief

This is a multicenter, open-label extension study for participants who participated in a previous Astex-sponsored guadecitabine clinical study \[including but not limited to SGI-110-01 (NCT01261312), SGI-110-04 (NCT02348489), SGI-110-06 (NCT02920008), and SGI-110-07 (NCT02907359)\].

Key facts

Study ID

NCT03603964

Run by

Astex Pharmaceuticals, Inc.

People needed

35

Starts

2018-07-18

Expected to finish

2021-10-04

Last updated by the study team

2024-08-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Previous participation in an Astex-sponsored guadecitabine clinical trial [including but not limited to SGI-110-01 (NCT01261312), SGI-110-04 (NCT03603964), SGI-110-05, SGI-110-06 (NCT02920008), and SGI-110-07 (NCT02907359)], in which the participant was treated with guadecitabine and was still on active treatment with guadecitabine at the time of database close for the prior study.
• Participant is considered to be benefitting from guadecitabine treatment in the opinion of the treating investigator.
• Able to understand and comply with the study procedures, understand the risks involved in the study, and provide written informed consent before any study-specific procedure.
• Women of child-bearing potential (according to recommendations of the Clinical Trial Facilitation Group [CTFG]) must not be pregnant or breastfeeding and must have a negative pregnancy test at screening. Women of child-bearing potential and men with female partners of child-bearing potential must agree to practice 2 highly effective contraceptive measures while receiving treatment with guadecitabine and for at least 3 months after completing treatment and must agree not to become pregnant or father a child while receiving study treatment and for at least 3 months after completing guadecitabine treatment.

You may not qualify if…

• 1. Any participant who, in the opinion of the investigator, may have other conditions, organ dysfunction, or have safety data from their prior study participation that suggest that the risks of continuing treatment with guadecitabine may outweigh the benefits.

Where it is running

• Roswell Park — Buffalo, New York, United States
• Duke Cancer Center — Durham, North Carolina, United States
• Ohio State University — Columbus, Ohio, United States
• Temple University — Philadelphia, Pennsylvania, United States
• Center for Blood Cancers — Nashville, Tennessee, United States
• Medizinische Universität Graz — Graz, Styria, Austria
• The Ottawa Hospital - General — Ottawa, Ontario, Canada
• Princess Margaret Cancer Center — Toronto, Ontario, Canada
• Rigshospitalet-Copenhagen University Hospital — Copenhagen, Denmark
• Azienda Ospedaliera SS. Antonio E. Biagio E. Cesare Arrigo di Alessandria — Alessandria, Italy
• Azienda Ospedaliera Universitaria San Martino — Genova, Italy
• Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico — Milan, Italy
• Azienda Ospedaliero Universitaria S. Maria della Misericordia di Udine — Udine, Italy
• Tokai University Hospital — Isehara-shi, Japan
• Japanese Red Cross Kyoto Daini Hospital — Kyoto, Japan
• Saga University Hospital — Saga, Japan
• Severance Hospital, Yonsei University Health System — Seoul, South Korea
• Ulsan University Hospital — Ulsan, South Korea
• Hospital Universitario 12 de Octubre — Madrid, Spain
• Mackay Memorial Hospital — Taipei, Taiwan
• National Taiwan University Hospital — Taipei, Taiwan

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.