CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 16 enrolled
Drug / intervention
Azacytidine +1 moredrug
Likely dose
Azacytidine 75 mg/m2from 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/NCT02196857
NCT02196857Phase 2Completed
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Phase II Study of Sorafenib Plus 5-Azacitidine for the Initial Therapy of Patients With Acute Myeloid Leukemia and High Risk Myelodysplastic Syndrome With FLT3-ITD Mutation

M.D. Anderson Cancer Center·interventional·Posted Jul 22, 2014·Updated Jan 14, 2020

In Brief

A Phase 2 clinical trial evaluating Azacytidine and Sorafenib for Leukemia. Completed, enrolled 16 participants across 1 site.

Detailed Summary

The goal of this clinical research study is to learn if 5-azacitidine and sorafenib can help to control the disease in patients with Acute Myeloid Leukemia (AML) and high risk Myelodisplastic Syndrome (MDS) with FLT3-ITD mutation. The safety of this drug combination will also be studied.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLeukemia
CountriesUnited States
CollaboratorsBayer

Timeline

Phase 2CompletedFinished
201520162017201820192020202120222023202420252026
First PostedJul 22, 2014
Enrollment StartFeb 6, 2015
Primary CompletionNov 27, 2018
TodayJul 2, 2026
Enrollment to primary: 3.8 yearsPosted 11.9 years ago

Interventions

Azacytidinedrug

75 mg/m2 administered subcutaneously (SQ) or intravenously (IV) on Days 1 - 7 for a 28 day cycle.

Sorafenibdrug

400 mg by mouth twice daily about 12 hours apart, every day for a 28 day cycle.