CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 43 enrolled
Drug / intervention
E7070 +3 moredrug
Likely dose
E7070 400 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/NCT01692197
NCT01692197Phase 2Completed
CompareCT.gov

A Phase 2 Study of E7070, Idarubicin and Cytarabine in Patients With Relapsed or Refractory Acute Myeloid Leukemia and High-risk Myelodysplastic Syndromes

M.D. Anderson Cancer Center·interventional·Posted Sep 25, 2012·Updated Jul 3, 2018

In Brief

A Phase 2 clinical trial evaluating E7070, Idarubicin, and 2 other interventions for Leukemia. Completed, enrolled 43 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLeukemia
CountriesUnited States
CollaboratorsEisai Inc.

Timeline

Phase 2CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedSep 25, 2012
Enrollment StartFeb 1, 2013
Primary CompletionJun 7, 2017
TodayJul 2, 2026
Enrollment to primary: 4.4 yearsPosted 13.8 years ago

Interventions

E7070drug

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

Idarubicindrug

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

Cytarabinedrug

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

Dexamethasonedrug

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