A clinical study to provide ongoing treatment with guadecitabine to subjects who were benefitting from guadecitabine treatment in a previous clinical study.

An Open-Label, Multicenter, Extension Study for Subjects Who Participated in Prior Guadecitabine Clinical Studies

Status

Not yet recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2017-004603-52-ES

Enrollment

250

Registered

2018-08-02

Start date

2018-09-17

Completion date

Unknown

Last updated

2018-10-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute myeloid leukemia (AML), myelodysplastic syndromes (MDS), and chronic myelomonocytic leukemia (CMML) MedDRA version: 20.0 Level: PT Classification code 10000880 Term: Acute myeloid leukaemia System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 20.0 Level: PT Classification code 10028533 Term: Myelodysplastic syndrome System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA versi

Interventions

Product Name: Guadecitabine Product Code: SGI-110 Pharmaceutical Form: Powder and solvent for solution for injection INN or Proposed INN: GUADECITABINE CAS Number: 929904-85-8 Current Sponsor code: SG

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Subjects must fulfill all of the following 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. Subject is 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 childbearing potential (according to recommendations of the Clinical Trial Facilitation Group[CTFG]; see protocol Section 5.2 for details) must not be pregnant or breastfeeding and must have a negative pregnancy test at screening. Women of childbearing potential and men with female partners of childbearing potential must agree to practice 2 highly effective contraceptive measures of birth control (as described in Section 5.2) and must agree not to become pregnant or father a child while receiving guadecitabine and for at least 3 months after completing guadecitabine treatment. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 1 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 249

Exclusion criteria

Exclusion criteria: Subjects meeting any of the following exclusion criteria will be excluded from the study: 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

Design outcomes

Primary

Measure	Time frame
Main Objective: To provide ongoing treatment with guadecitabine for subjects who benefited from guadecitabine treatment in a previous Astex-sponsored clinical study and to obtain long-term safety information.;Secondary Objective: To obtain long-term survival information on subjects who participated in a previous Astex-sponsored guadecitabine clinical study.;Primary end point(s): Safety as measured by adverse events;Timepoint(s) of evaluation of this end point: For the primary endpoint of safety as assessed by adverse events, this process is ongoing, and rather than occurring at specific pre-specified timepoints. Practically, the SGI-110 program is reviewed at least quarterly for any changes in safety profile, but based on new events reported may be reviewed at any time. Summary safety tables specific to Study SGI-110-12 would be completed after the last patient has discontinued treatment and been withdrawn from the study.	—

Measure

Time frame

Main Objective: To provide ongoing treatment with guadecitabine for subjects who benefited from guadecitabine treatment in a previous Astex-sponsored clinical study and to obtain long-term safety information.;Secondary Objective: To obtain long-term survival information on subjects who participated in a previous Astex-sponsored guadecitabine clinical study.;Primary end point(s): Safety as measured by adverse events;Timepoint(s) of evaluation of this end point: For the primary endpoint of safety as assessed by adverse events, this process is ongoing, and rather than occurring at specific pre-specified timepoints. Practically, the SGI-110 program is reviewed at least quarterly for any changes in safety profile, but based on new events reported may be reviewed at any time. Summary safety tables specific to Study SGI-110-12 would be completed after the last patient has discontinued treatment and been withdrawn from the study.

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Secondary

Measure	Time frame
Secondary end point(s): Survival status.;Timepoint(s) of evaluation of this end point: For the secondary endpoint of survival, there are no planned interim analyses planned and survival data would be summarized after the last subject has discontinued treatment and been withdrawn from the study.	—

Countries

Austria, Canada, Denmark, France, Hungary, Italy, Japan, Korea, Republic of, Poland, Spain, Taiwan, United States

Contacts

Public ContactClinical trial info SGI-110-012

Astex Pharmaceuticals, Inc.

SGI110-12@astx.com

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026