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Study of ASTX727 vs IV Decitabine in Participants With MDS, CMML, and AML

NCT03306264 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 227

Last updated 2024-08-27

Study results available
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Summary

Multicenter PK study of ASTX727 versus IV decitabine. Adult participants who were candidates to receive IV decitabine were randomized 1:1 to receive the ASTX727 tablet Daily×5 in Cycle 1 followed by IV decitabine 20 mg/m\^2 Daily×5 in Cycle 2, or the converse order. After completion of PK studies during the first 2 treatment cycles, participants continued to receive treatment with ASTX727 from Cycle 3 onward (in 28-day cycles) until disease progression, unacceptable toxicity, or the participants discontinued treatment or withdrew from the study.

Conditions

Interventions

DRUG

ASTX727

ASTX727 oral tablet

DRUG

Dacogen

Decitabine 20 mg/m\^2 one-hour IV infusion

Sponsors & Collaborators

  • Astex Pharmaceuticals, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-02-15
Primary Completion
2021-09-10
Completion
2023-05-25
FDA Drug
Yes

Countries

  • United States
  • Austria
  • Canada
  • Czechia
  • France
  • Germany
  • Hungary
  • Italy
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03306264 on ClinicalTrials.gov