Guadecitabine Extension Study
This is a multicenter, open-label extension study for subjects who participated in a previous Astex-sponsored guadecitabine clinical study (including but not limited to SGI-110-01, SGI-110-04, SGI-110-06, and SGI-110-07).
|Condition or Disease||Intervention/Treatment||Phase|
Subjects who were still receiving treatment with guadecitabine and in the opinion of the investigator were still benefitting from treatment at the time of database close of the original study will be eligible to participate in this extension study. Approximately 250 subjects could be enrolled.
Subjects will attend clinic visits on Days 1-5 of each 28-day cycle to receive treatment with guadecitabine. Data collection will be limited to treatment exposure, adverse events, concomitant medications, limited laboratory parameters, and survival status.
Arms and Interventions
Subjects will receive guadecitabine treatment at the same dose that they were receiving in the last cycle of their prior study or at a different dose as guided by the dose adjustment guidelines in the prior study protocol. Treatment may continue as long as the subject continues to benefit based on investigator judgment.
Primary Outcome Measures
- Incidence of Adverse Events [2 years]
Secondary Outcome Measures
- Survival Status [2 years]
Previous participation in an Astex-sponsored guadecitabine clinical trial (including but not limited to SGI-110-01, SGI-110-04, SGI-110-05, SGI-110-06, and SGI-110-07), in which the subject was treated with guadecitabine and was still on active treatment with guadecitabine at the time of database close for the prior study.
Subject 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.
- Any subject 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.
Contacts and Locations
|1||Roswell Park||Buffalo||New York||United States||14263|
|2||Duke Cancer Center||Durham||North Carolina||United States||27705|
|3||Ohio State University||Columbus||Ohio||United States||43210|
|4||Temple University||Philadelphia||Pennsylvania||United States||19111|
|5||Center for Blood Cancers||Nashville||Tennessee||United States||37203|
|6||Medizinische Universität Graz||Graz||Styria||Austria|
|7||The Ottawa Hospital - General||Ottawa||Ontario||Canada||K1H 8L6|
|8||Princess Margaret Cancer Center||Toronto||Ontario||Canada||M5G 2M9|
|9||Rigshospitalet-Copenhagen University Hospital||Copenhagen||Denmark|
|10||Azienda Ospedaliera SS. Antonio E. Biagio E. Cesare Arrigo di Alessandria||Alessandria||Italy|
|11||Azienda Ospedaliera Universitaria San Martino||Genova||Italy|
|12||Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico||Milano||Italy|
|13||Azienda Ospedaliero Universitaria S. Maria della Misericordia di Udine||Udine||Italy|
|14||Tokai University Hospital||Isehara-shi||Japan||259-1193|
|15||Japanese Red Cross Kyoto Daini Hospital||Kyoto-shi||Japan||602-8026|
|16||Saga University Hospital||Saga-shi||Japan||849-8501|
|17||Severance Hospital, Yonsei University Health System||Seoul||Korea, Republic of||03722|
|18||Ulsan University Hospital||Ulsan||Korea, Republic of||44033|
|19||Hospital Universitario 12 de Octubre||Madrid||Spain|
|20||Mackay Memorial Hospital||Taipei||Taiwan|
|21||National Taiwan University Hospital||Taipei||Taiwan|
Sponsors and Collaborators
- Astex Pharmaceuticals, Inc.
Study Documents (Full-Text)None provided.