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NCT00980018 · ClinicalTrials.gov registry record · Phase 4

An Exploratory Trial to Assess the Improvement of Adverse Events in Chronic Myelogenous Leukemia Patients Treated With Imatinib When Switched to Nilotinib Treatment

A Phase 4 study of Chronic Myelogenous Leukemia, sponsored by Novartis Pharmaceuticals.

Completed
Registry status
Phase 4
Development phase
52
Enrollment target
20
Study locations

NCT00980018 is a Phase 4 study of Chronic Myelogenous Leukemia that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 52 participants, below the 281-participant average among 29 other Chronic Myelogenous Leukemia trials with a reported enrollment target (81% lower). The trial reports 20 study locations across 12 states.

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The verdict

NCT00980018, a Phase 4 study of Chronic Myelogenous Leukemia, has completed, sponsored by Novartis Pharmaceuticals.

COMPLETED
Registry status
Phase 4
Development phase
52 participants
Enrollment target
20
Study locations

Study Summary

The purpose of this exploratory study will be to examine changes in chronic low grade chronic adverse events, measured by Common Terminology Criteria for Adverse Events (CTCAE) grading, when patients are switched from imatinib to nilotinib therapy.

Interventions

  • DRUG Nilotinib

Study Locations (20)

Texas

  • Texas Oncology, P.A. - Bedford
  • Presbyterian Hospital of Dallas TexasOncology@PresbyterianHosp - Dallas
  • Texas Oncology Texas Oncology - Sugar Land - Dallas
  • MD Anderson Cancer Center/University of Texas - Houston
  • Cancer Care Centers of South Texas / HOAST CCC of So. TX- San Antonio(2) - San Antonio

Arkansas

  • Highlands Oncology Group - Fayetteville
  • Hematology Oncology Services of Arkansas SC - Little Rock

California

  • USC Norris Cancer Center LAC & USC Medical Center - Los Angeles
  • Southwest Cancer Care Murrieta - Poway

Florida

  • Florida Cancer Institute - New Port Richey
  • Cancer Centers of Florida PA Cancer Centers of FL-Orlando-4 - Ocoee

Oregon

  • Northwest Cancer Specialists Salmon Creek Office - Portland
  • Oregon Health Sciences University - Portland

Colorado

  • Rocky Mountain Cancer Centers RMCC - Aurora - Greenwood Village

Illinois

  • Stroger Cook County Hospital John H. Stroger Hospital - Chicago

Indiana

  • St. Francis Hospital and Health Centers IndianaBlood&MarrowTransplantn - Beech Grove

Trial Details

FieldValue
Enrollment Target 52 participants
Start Date 2009-12
Est. Completion 2012-12
Phase Phase 4

Sponsor

Novartis Pharmaceuticals

1,375 total trials

What the Registry Record Tells You About NCT00980018

The ClinicalTrials.gov registry entry for NCT00980018 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 52 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 281-participant average among 29 other Chronic Myelogenous Leukemia trials with a reported enrollment target (81% lower). The listed sponsor is Novartis Pharmaceuticals, which has 1,375 total studies on file at ClinicalTrials.gov.

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

NCT00980018 reports 20 study locations spanning 12 distinct geographic areas - top geographies include Texas, Arkansas, California.

Frequently Asked Questions

What is clinical trial NCT00980018 about?

NCT00980018 is a clinical study titled "An Exploratory Trial to Assess the Improvement of Adverse Events in Chronic Myelogenous Leukemia Patients Treated With Imatinib When Switched to Nilotinib Treatment". The purpose of this exploratory study will be to examine changes in chronic low grade chronic adverse events, measured by Common Terminology Criteria for Adverse Events (CTCAE) grading, when patients are switched from imatinib to nilotinib therapy.

What is the current status of trial NCT00980018?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 52 participants. The study started on 2009-12. Estimated completion is 2012-12.

What conditions does trial NCT00980018 study?

This clinical trial studies the following conditions: Chronic Myelogenous Leukemia.

What interventions are being tested in trial NCT00980018?

The interventions under investigation include: Nilotinib (DRUG).

Who is sponsoring clinical trial NCT00980018?

This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00980018 being conducted?

This trial has 20 study locations across Arkansas, California, Colorado, Florida, Illinois. 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

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