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E7070, Idarubicin and Cytarabine in Relapsed AML and High-Risk Myelodysplastic Syndromes

NCT01692197 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 43

Last updated 2018-07-03

Study results available
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Summary

The goal of this clinical research study is to learn if E7070 in combination with idarubicin, cytarabine, and dexamethasone can help to control the disease in patients with either AML or high-risk MDS that has relapsed. The safety of the drug combination will also be studied.

Conditions

Interventions

DRUG

E7070

400 mg/m2 intravenously over 1 hour on Day 1 and Day 8 every 3 weeks.

DRUG

Idarubicin

8 mg/m2 by vein over 1 hour daily for 3 days (Days 9-11).

DRUG

Cytarabine

1.0 g/m2 by vein daily on Days 9 - 12 (age \<60 years) or Days 9 - 11 (age \> 60 years).

DRUG

Dexamethasone

10 mg by vein daily for 3 - 4 days with cytarabine.

Sponsors & Collaborators

  • Eisai Inc.

    collaborator INDUSTRY

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Gautam Borthakur, MBBS · M.D. 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
2013-02-01
Primary Completion
2017-06-07
Completion
2017-06-07
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

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 NCT01692197 on ClinicalTrials.gov