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NCT01164163 · ClinicalTrials.gov registry record · Phase 1

INCB18424 in Treating Young Patients With Relapsed or Refractory Solid Tumor, Leukemia, or Myeloproliferative Disease

A Phase 1 study of Leukemia and Myelodysplastic Syndromes, sponsored by Children's Oncology Group.

Completed
Registry status
Phase 1
Development phase
49
Enrollment target
20
Study locations

NCT01164163 is a Phase 1 study of Leukemia and Myelodysplastic Syndromes that has completed, run by Children's Oncology Group. The registered enrollment target is 49 participants, below the 487-participant average among 233 other Leukemia trials with a reported enrollment target (90% lower). The trial reports 20 study locations across 17 states.

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The verdict

NCT01164163, a Phase 1 study of Leukemia and Myelodysplastic Syndromes, has completed, sponsored by Children's Oncology Group.

COMPLETED
Registry status
Phase 1
Development phase
49 participants
Enrollment target
20
Study locations

Study Summary

RATIONALE: INCB18424 (Ruxolitinib) may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. PURPOSE: This phase 1 clinical trial is studying the side effects and best dose of INCB18424 in treating young patients with relapsed or refractory solid tumor, leukemia, or myeloproliferative disease.

Interventions

  • OTHER laboratory biomarker analysis
  • OTHER pharmacological study
  • DRUG ruxolitinib phosphate

Study Locations (20)

California

  • Children's Hospital of Orange County - Orange
  • UCSF Helen Diller Family Comprehensive Cancer Center - San Francisco

Maryland

  • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins - Baltimore
  • Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office - Bethesda

Pennsylvania

  • Children's Hospital of Philadelphia - Philadelphia
  • Children's Hospital of Pittsburgh of UPMC - Pittsburgh

Alabama

  • UAB Comprehensive Cancer Center - Birmingham

Colorado

  • Children's Hospital Colorado Center for Cancer and Blood Disorders - Aurora

District of Columbia

  • Children's National Medical Center - Washington D.C.

Georgia

  • AFLAC Cancer Center and Blood Disorders Service of Children's Healthcare of Atlanta - Egleston Campus - Atlanta

Illinois

  • Children's Memorial Hospital - Chicago - Chicago

Trial Details

FieldValue
Enrollment Target 49 participants
Start Date 2010-09
Phase Phase 1

Sponsor

Children's Oncology Group

342 total trials

What the Registry Record Tells You About NCT01164163

The ClinicalTrials.gov registry entry for NCT01164163 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 49 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 (90% lower). The listed sponsor is Children's Oncology Group, which has 342 total studies on file at ClinicalTrials.gov.

The record links to 5 conditions, with Leukemia appearing as the primary indexed condition, and to 3 interventions - of which laboratory biomarker analysis is the first listed.

NCT01164163 reports 20 study locations spanning 17 distinct geographic areas - top geographies include California, Maryland, Pennsylvania.

Frequently Asked Questions

What is clinical trial NCT01164163 about?

NCT01164163 is a clinical study titled "INCB18424 in Treating Young Patients With Relapsed or Refractory Solid Tumor, Leukemia, or Myeloproliferative Disease". RATIONALE: INCB18424 (Ruxolitinib) may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. PURPOSE: This phase 1 clinical trial is studying the side effects and best dose of INCB18424 in treating young patients with relapsed or refractory solid tumor, leukemia, o...

What is the current status of trial NCT01164163?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 49 participants. The study started on 2010-09.

What conditions does trial NCT01164163 study?

This clinical trial studies the following conditions: Leukemia, Myelodysplastic Syndromes, Chronic Myeloproliferative Disorders, Myelodysplastic/Myeloproliferative Neoplasms, Unspecified Childhood Solid Tumor, Protocol Specific.

What interventions are being tested in trial NCT01164163?

The interventions under investigation include: laboratory biomarker analysis (OTHER), pharmacological study (OTHER), ruxolitinib phosphate (DRUG).

Who is sponsoring clinical trial NCT01164163?

This trial is sponsored by Children's Oncology Group, which has 342 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01164163 being conducted?

This trial has 20 study locations across Alabama, California, Colorado, District of Columbia, Georgia. 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.