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NCT01396499 · ClinicalTrials.gov registry record · Phase 1

Study to Assess Safety, Tolerability and Preliminary Efficacy of BKM120, PI3K Kinase Inhibitor, With Advanced Leukemias

A Phase 1 study of Leukemia, sponsored by M.D. Anderson Cancer Center.

Completed
Registry status
Phase 1
Development phase
16
Enrollment target
1
Study location

NCT01396499 is a Phase 1 study of Leukemia that has completed, run by M.D. Anderson Cancer Center. The registered enrollment target is 16 participants, below the 487-participant average among 233 other Leukemia trials with a reported enrollment target (97% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT01396499, a Phase 1 study of Leukemia, has completed, sponsored by M.D. Anderson Cancer Center.

COMPLETED
Registry status
Phase 1
Development phase
16 participants
Enrollment target
1
Study location

Study Summary

The goal of this clinical research study is to find the highest tolerable dose of BKM120 that can be given to patients with relapsed or refractory leukemia. The safety of BKM120 will also be studied.

Conditions Studied

Interventions

  • DRUG BKM120

Study Locations (1)

Texas

  • University of Texas MD Anderson Cancer Center - Houston

Trial Details

FieldValue
Enrollment Target 16 participants
Start Date 2012-07
Est. Completion 2016-10
Phase Phase 1

Sponsor

M.D. Anderson Cancer Center

2,692 total trials

What the Registry Record Tells You About NCT01396499

The ClinicalTrials.gov registry entry for NCT01396499 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 16 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 487-participant average among 233 other Leukemia trials with a reported enrollment target (97% lower). The listed sponsor is M.D. Anderson Cancer Center, which has 2,692 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Leukemia appearing as the primary indexed condition, and to 1 intervention - of which BKM120 is the first listed.

NCT01396499 reports 1 study location spanning 1 distinct geographic area - top geographies include Texas.

Frequently Asked Questions

What is clinical trial NCT01396499 about?

NCT01396499 is a clinical study titled "Study to Assess Safety, Tolerability and Preliminary Efficacy of BKM120, PI3K Kinase Inhibitor, With Advanced Leukemias". The goal of this clinical research study is to find the highest tolerable dose of BKM120 that can be given to patients with relapsed or refractory leukemia. The safety of BKM120 will also be studied.

What is the current status of trial NCT01396499?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 16 participants. The study started on 2012-07. Estimated completion is 2016-10.

What conditions does trial NCT01396499 study?

This clinical trial studies the following conditions: Leukemia.

What interventions are being tested in trial NCT01396499?

The interventions under investigation include: BKM120 (DRUG).

Who is sponsoring clinical trial NCT01396499?

This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01396499 being conducted?

This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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.