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

NCT00542971 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 78

Last updated 2018-08-23

Study results available
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Summary

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.

Conditions

Interventions

DRUG

Idarubicin

12 mg/m\^2 IV over 1 hour daily (days 1-3)

DRUG

Sorafenib

Starting dose 400 mg by mouth for 7 days

DRUG

Ara-C

1.5 g/m\^2 IV over 24 hours daily (days 1-4)

Sponsors & Collaborators

  • Bayer

    collaborator INDUSTRY

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Farhad Ravandi-Kashani, MD · M.D. Anderson Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
15 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-10-31
Primary Completion
2011-05-31
Completion
2011-05-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

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 NCT00542971 on ClinicalTrials.gov