CI

At a glance

ClinicalIndex Comparison Record
N/AUnknown· 26 enrolled
Drug / intervention
Alisertib +2 moredrug
Likely dose
Not stated in 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/NCT02530619
NCT02530619N/AUnknown

A Multicenter, Open-Label, Pilot Study of Alisertib (MLN8237), a Novel Inhibitor of Aurora Kinase A, in Adult Patients With Relapsed/Refractory Acute Megakaryoblastic Leukemia or Myelofibrosis (Including Primary and Post-Essential/Post-Polycythemic Myelofibrosis)

Northwestern University·interventional·Posted Aug 21, 2015·Updated May 26, 2021

In Brief

A clinical study evaluating Alisertib, Laboratory Biomarker Analysis, and 1 other intervention for Acute Megakaryoblastic Leukemia and 2 related conditions. Targeting 26 participants across 3 sites.

Detailed Summary

The purpose of this study is to evaluate the safety of alisertib and its effect, bad and/or good, on acute megakaryoblastic leukemia (AMKL) or myelofibrosis (MF). The study drug, alisertib, is an investigational drug. An investigational drug is one that has not been approved by the U.S. Food and Drug Administration (FDA). Alisertib has shown evidence in the lab that it may have an effect on a type of cell that produces platelets. This cell is called a megakaryocyte and it is known to be defective (doesn't work well) in both AMKL and MF.

Study Details

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

Timeline

N/AUnknownOverdue
20162017201820192020202120222023202420252026
First PostedAug 21, 2015
Enrollment StartOct 9, 2015
Primary CompletionMay 21, 2018
Study CompletionMay 1, 2022
TodayJul 2, 2026
Enrollment to primary: 2.6 yearsPosted 10.9 years ago

Interventions

Alisertibdrug

Given PO

Laboratory Biomarker Analysisother

Correlative studies

Pharmacological Studyother

Correlative studies