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Sorafenib and 5-Azacitidine in Acute Leukemia + Myelodysplastic Syndrome

NCT01254890 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2016-05-06

Study results available
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Summary

The goal of this clinical research study is to learn if 5-azacitidine and sorafenib can control the disease in patients with AML or MDS. The safety of this drug combination will also be studied.

Conditions

Interventions

DRUG

Azacitidine

75 mg/m\^2 subcutaneously (SQ) or by vein (IV) daily for 7 days per 28 day cycle.

DRUG

Sorafenib

Starting dose level 200 mg by mouth two times a day in a 28 day cycle. In Phase II, Sorafenib administered per MTD dose from Phase I. Drug doses separated by approximately 12 hours.

Sponsors & Collaborators

  • Bayer

    collaborator INDUSTRY

  • Onyx Therapeutics, Inc.

    collaborator INDUSTRY

  • Celgene

    collaborator INDUSTRY

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Farhad Ravandi-Kashani, MD · UT MD Anderson Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-01-31
Primary Completion
2015-03-31
Completion
2015-03-31

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 NCT01254890 on ClinicalTrials.gov