Guadecitabine Extension Study

• Status: Active, not recruiting
• Trial end date: 2021-08-31
• Target enrollment: 0
• Participant gender: All

Summary

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Astex Pharmaceuticals; Astex Pharmaceuticals, Inc.
• Treatments: Azacitidine; Guadecitabine

Criteria

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.