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

2019-09-24 05:27:40 | BioPortfolio

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).

Description

The objectives of this extension study are to provide ongoing long-term treatment with ASTX727 for subjects who were benefitting from ASTX727 treatment in a previous Astex-sponsored clinical study (parent study); to obtain long-term safety information; and to obtain survival information.

Subjects will attend clinic visits on Day 1 of each 28-day cycle to undergo study procedures and to be given ASTX727 tablets for Days 1-5 of that dose cycle. Subjects should continue to receive the same ASTX727 dose and regimen they were receiving in the last cycle of the parent study in which they were originally enrolled. Subsequent treatment delays and/or dose reductions are at the discretion of the investigator as guided by the dose adjustment guidelines of the parent study protocol.

Study Design

Conditions

Acute Myeloid Leukemia

Intervention

ASTX727

Status

Not yet recruiting

Source

Astex Pharmaceuticals, Inc.

Results (where available)

View Results

Links

Published on BioPortfolio: 2019-09-24T05:27:40-0400

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