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NCT02236013 · ClinicalTrials.gov registry record · Phase 1

A Study of ASP2215 in Combination With Induction and Consolidation Chemotherapy in Patients With Newly Diagnosed Acute Myeloid Leukemia

A Phase 1 study of Acute Myeloid Leukemia, sponsored by Astellas Pharma Global Development.

Completed
Registry status
Phase 1
Development phase
80
Enrollment target
10
Study locations

NCT02236013 is a Phase 1 study of Acute Myeloid Leukemia that has completed, run by Astellas Pharma Global Development. The registered enrollment target is 80 participants, below the 116-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (31% lower). The trial reports 10 study locations across 10 states.

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The verdict

NCT02236013, a Phase 1 study of Acute Myeloid Leukemia, has completed, sponsored by Astellas Pharma Global Development.

COMPLETED
Registry status
Phase 1
Development phase
80 participants
Enrollment target
10
Study locations

Study Summary

The purpose of this study is to describe the dose limiting toxicities (DLT) and define the maximum tolerated dose (MTD) of ASP2215 when combined with cytarabine/idarubicin or daunorubicin remission induction in a 7+3 schedule. Safety and tolerability of ASP2215 will also be evaluated. This study will also characterize the pharmacokinetics (PK) of ASP2215 when given in combination with cytarabine/idarubicin or cytarabine/daunorubicin remission induction and high-dose cytarabine (HiDAC) consolidation therapy in newly diagnosed acute myeloid leukemia as well as evaluate the effect of ASP2215 on the PK of cytarabine.

Conditions Studied

Acute Myeloid Leukemia

Interventions

  • DRUG Cytarabine
  • DRUG Idarubicin
  • DRUG Daunorubicin
  • DRUG Gilteritinib

Study Locations (10)

California

  • Site US10003 - Los Angeles

Connecticut

  • Site US10013 - New Haven

Illinois

  • Site US10004 - Chicago

Kansas

  • Site US10009 - Westwood

Maryland

  • Site US10001 - Baltimore

New York

  • Site US10002 - New York

Ohio

  • Site US10014 - Cleveland

Oklahoma

  • Site US10019 - Oklahoma City

Trial Details

FieldValue
Enrollment Target 80 participants
Start Date 2015-01-07
Est. Completion 2021-07-26
Phase Phase 1

Sponsor

Astellas Pharma Global Development

168 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT02236013

The ClinicalTrials.gov registry entry for NCT02236013 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 80 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 116-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (31% lower). The listed sponsor is Astellas Pharma Global Development, which has 168 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Acute Myeloid Leukemia appearing as the primary indexed condition, and to 4 interventions - of which Cytarabine is the first listed.

NCT02236013 reports 10 study locations spanning 10 distinct geographic areas - top geographies include California, Connecticut, Illinois.

Frequently Asked Questions

What is clinical trial NCT02236013 about?

NCT02236013 is a clinical study titled "A Study of ASP2215 in Combination With Induction and Consolidation Chemotherapy in Patients With Newly Diagnosed Acute Myeloid Leukemia". The purpose of this study is to describe the dose limiting toxicities (DLT) and define the maximum tolerated dose (MTD) of ASP2215 when combined with cytarabine/idarubicin or daunorubicin remission induction in a 7+3 schedule. Safety and tolerability of ASP2215 will also be evaluated. This study wil...

What is the current status of trial NCT02236013?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 80 participants. The study started on 2015-01-07. Estimated completion is 2021-07-26.

What conditions does trial NCT02236013 study?

This clinical trial studies the following conditions: Acute Myeloid Leukemia.

What interventions are being tested in trial NCT02236013?

The interventions under investigation include: Cytarabine (DRUG), Idarubicin (DRUG), Daunorubicin (DRUG), Gilteritinib (DRUG).

Who is sponsoring clinical trial NCT02236013?

This trial is sponsored by Astellas Pharma Global Development, which has 168 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT02236013 being conducted?

This trial has 10 study locations across California, Connecticut, Illinois, Kansas, Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.