Guadecitabine Extension Study
Status: | Not yet recruiting |
---|---|
Conditions: | Blood Cancer |
Therapuetic Areas: | Oncology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 7/29/2018 |
Start Date: | July 23, 2018 |
End Date: | July 1, 2020 |
Contact: | Valerie Ahanonu |
Email: | Valerie.Ahanonu@astx.com |
Phone: | 925-560-2921 |
An Open-Label, Multicenter, Extension Study for Subjects Who Participated in Prior Guadecitabine Clinical Studies
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).
Astex-sponsored guadecitabine clinical study (including but not limited to SGI-110-01,
SGI-110-04, SGI-110-06, and SGI-110-07).
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.
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.
Inclusion Criteria:
1. 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.
2. Subject is considered to be benefitting from guadecitabine treatment in the opinion of
the treating investigator.
3. 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.
4. 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.
Exclusion Criteria:
- 1. 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.
We found this trial at
6
sites
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Ohio State University The Ohio State University’s main Columbus campus is one of America’s largest...
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Temple University Temple University is many things to many people. A place to pursue life's...
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