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Pharmacokinetic Guided Dose Escalation and Dose Confirmation With Oral Decitabine and Oral Cytidine Deaminase Inhibitor (CDAi) in Patients With Myelodysplastic Syndromes (MDS)

NCT02103478 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 130

Last updated 2024-08-27

Study results available
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Summary

This first-in-human, 3-stage, open-label study evaluated the safety and pharmacokinetics of ASTX727, as well as determined the dose for later stages.

Conditions

Interventions

DRUG

ASTX727 Dose Escalation

Oral investigational product and approved IV decitabine

DRUG

ASTX727 Dose Confirmation

Randomization cross over design for courses 1 and 2

DRUG

ASTX727 Fixed-Dose Combination

Fixed-dose investigational product

Sponsors & Collaborators

  • Astex Pharmaceuticals, Inc.

    lead INDUSTRY

Principal Investigators

  • Mohammad Azab, MD · Astex Pharmaceuticals, Inc.

  • James Lowder, MD · Astex Pharmaceuticals, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-10-28
Primary Completion
2018-06-05
Completion
2019-12-04

Countries

  • United States
  • Canada

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 NCT02103478 on ClinicalTrials.gov