An Open-Label, Multicenter, Extension Study for Subjects Who Participated in Prior Clinical Studies of ASTX727 (Standard Dose)

• Status: Enrolling by invitation
• Trial end date: 2024-12-31
• Target enrollment: 0
• Participant gender: All

Summary

Extension study for subjects who participated in a previous Astex-sponsored clinical study of ASTX727 (including, but not limited to ASTX727-01, ASTX727-02, ASTX727-04).

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

Details

• Lead Sponsor: Astex Pharmaceuticals, Inc.
• Treatments: Decitabine

Criteria

Inclusion Criteria:

Subjects must fulfill all of the following inclusion criteria:

1. Previous participation in an Astex-sponsored ASTX727 clinical trial (including, but not limited to studies ASTX727-01, ASTX727-02, and ASTX727-04) in which the subject was treated with ASTX727 and was still on active treatment with ASTX727 at the time of study completion as determined by Astex.

2. Subject is considered to be benefitting from ASTX727 treatment in the opinion of the treating investigator at the time of parent study completion (Subjects must not be withdrawn from the parent study until eligibility for this study is confirmed).

3. Subject is able to understand and comply with the study procedures and understands the risks involved in the study.

4. Subject provides legally effective informed consent before undergoing any study-specific procedure.

5. Women of childbearing potential must not be pregnant or breastfeeding and must have a negative pregnancy test at screening. Women of childbearing potential must agree to practice 2 highly effective contraceptive methods of birth control and must agree not to become pregnant for 6 months after completing treatment; men with female partners of childbearing potential must agree to practice 2 highly effective contraceptive measures and must agree not to father a child while receiving ASTX727 and for at least 3 months after completing ASTX727 treatment.

Exclusion Criterion:

1. Any subject who, in the opinion of the investigator, may have other conditions, organ dysfunction, or for whom safety data from parent study participation suggests the risks of continuing treatment with ASTX727 may outweigh the benefits.