CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 78 enrolled
Drug / intervention
Idarubicin +2 moredrug
Likely dose
Idarubicin 12 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00542971
NCT00542971Phase 2Completed
CompareCT.gov

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

M.D. Anderson Cancer Center·interventional·Posted Oct 12, 2007·Updated Aug 23, 2018

In Brief

A Phase 2 clinical trial evaluating Idarubicin, Sorafenib, and 1 other intervention for AML and 2 related conditions. Completed, enrolled 78 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAML, Acute Myeloid Leukemia, Myelodysplastic Disorders
CountriesUnited States
CollaboratorsBayer

Timeline

Phase 2CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedOct 12, 2007
Enrollment StartOct 1, 2007
Primary CompletionMay 1, 2011
TodayJul 2, 2026
Enrollment to primary: 3.6 yearsPosted 18.7 years ago

Interventions

Idarubicindrug

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

Sorafenibdrug

Starting dose 400 mg by mouth for 7 days

Ara-Cdrug

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