NCT03603964

Guadecitabine Extension Study

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

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 35 (actual)
• Sponsor: Astex Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a multicenter, open-label extension study for participants who participated in a previous Astex-sponsored guadecitabine clinical study \[including but not limited to SGI-110-01 (NCT01261312), SGI-110-04 (NCT02348489), SGI-110-06 (NCT02920008), and SGI-110-07 (NCT02907359)\].

Detailed description

Participants 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. Participants 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.

Conditions

• Acute Myeloid Leukemia
• Myeloid Dysplastic Syndrome

Interventions

Type	Name	Description
DRUG	Guadecitabine	Guadecitabine

Timeline

• Start date: 2018-07-18
• Primary completion: 2021-10-04
• Completion: 2021-10-04
• First posted: 2018-07-27
• Last updated: 2024-08-27
• Results posted: 2023-04-26

Locations

21 sites across 9 countries: United States, Austria, Canada, Denmark, Italy, Japan, South Korea, Spain, Taiwan

Regulatory

• FDA-regulated drug study