Completed PHASE2 INTERVENTIONAL 2-arm NCT00414310

Decitabine (DAC) w/ or w/o Valproic Acid (VPA) in Myelodysplastic Syndrome (MDS) and Acute Myelogenous Leukemia (AML)

Phase II Randomized Study of Low-Dose Decitabine (5-AZA-2'-Deoxycytidine) With or Without Valproic Acid in Myelodysplastic Syndrome (MDS) and Acute Myelogenous Leukemia -SPORE

Sponsor: Eisai Inc.

Conditions Acute Myelogenous Leukemia Myelodysplastic Syndrome

Interventions Decitabine Valproic Acid

Updated 7 times since 2017 Last updated: May 2, 2019 Started: Dec 31, 2006 Primary completion: May 31, 2015 Completion: May 31, 2015

This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

A PHASE2 clinical study on Acute Myelogenous Leukemia and Myelodysplastic Syndrome, this trial is completed. The trial is conducted by Eisai Inc. and has accumulated 7 data snapshots since 2006. Oncology trials at this stage typically focus on safety, tolerability, and early efficacy signals.

Status Flow

Change History

7 versions recorded

Sep 2024 — Present [monthly]

Completed PHASE2
Jul 2024 — Sep 2024 [monthly]

Completed PHASE2
Jan 2021 — Jul 2024 [monthly]

Completed PHASE2
Jun 2019 — Jan 2021 [monthly]

Completed PHASE2
Jun 2018 — Jun 2019 [monthly]

Completed PHASE2

▶ Show 2 earlier versions

Feb 2017 — Jun 2018 [monthly]

Completed PHASE2
Jan 2017 — Feb 2017 [monthly]

Completed PHASE2

First recorded

Dec 2006

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:

Eisai Inc.
M.D. Anderson Cancer Center

Data source: M.D. Anderson Cancer Center

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

• Houston, United States