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

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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).

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.

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
Durham, North Carolina 27710
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Buffalo, New York 14263
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Buffalo, NY
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281 W. Lane Ave
Columbus, Ohio 43210
(614) 292-6446
Ohio State University The Ohio State University’s main Columbus campus is one of America’s largest...
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Columbus, OH
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2 Auenbruggerplatz
Graz, Styria 8036
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Graz,
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Nashville, Tennessee 37203
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Nashville, TN
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1801 N Broad St
Philadelphia, Pennsylvania 19122
(215) 204-7000
Temple University Temple University is many things to many people. A place to pursue life's...
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Philadelphia, PA
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