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Completed Phase 1Phase 2 Interventional Results available

Phase I-II Study of Idarubicin, Cytarabine, and Sorafenib (BAY43-9006)

ClinicalTrials.gov ID: NCT00542971

Public ClinicalTrials.gov record NCT00542971. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 17, 2026, 8:54 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

Phase I-II Study of Idarubicin, Cytarabine, and Sorafenib (BAY43-9006), an Oral Vascular Endothelial Growth Factor (VEGF), Rapidly Accelerated Fibrosarcoma (RAF) and FMS-like Tyrosine Kinase 3 (FLT3), in Patients With High-risk MDS and AML

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

A primary goal of this clinical research study is to find the highest safe dose of sorafenib that can be given in combination with idarubicin and Ara-C for the treatment of acute myelogenous leukemia (AML) and high-risk, myelodysplastic syndrome (MDS). Once the highest safe dose is found, researchers will then try to learn if this combination treatment can help control AML and high-risk MDS in newly diagnosed patients. The safety of this treatment combination will also be studied.

Study identification

NCT ID
NCT00542971
Recruitment status
Completed
Study type
Interventional
Phase
Phase 1, Phase 2
Enrollment
78 participants

Conditions and interventions

Eligibility (public fields only)

Age range
15 Years to 60 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Sep 30, 2007
Primary completion
Apr 30, 2011
Completion
Apr 30, 2011
Last update posted
Aug 22, 2018

2007 – 2011

United States locations

U.S. sites
1
U.S. states
1
U.S. cities
1
Facility City State ZIP Site status
The University of Texas M.D. Anderson Cancer Center Houston Texas 77030

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00542971, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Aug 22, 2018 · Synced Sep 17, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT00542971 live on ClinicalTrials.gov.

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