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COMPLETED Phase 1

A Study of Oral AMN107 in Adults With Chronic Myelogenous Leukemia (CML) or Other Hematologic Malignancies

NCT00109707 · View on ClinicalTrials.gov ↗

Study Summary

The purpose of this trial is to assess the efficacy, safety, tolerability, biologic activity, and pharmacokinetics of AMN107 in six groups of patients with one of the following conditions: Relapsed/refractory Ph+ Acute lymphoblastic leukemia (ALL) (arm 1) Group A - Imatinib failure only (arms 2, 3 and 4) * imatinib-resistant or intolerant CML - Chronic Phase (CP) * imatinib-resistant or intolerant CML - Accelerated Phase (AP) * imatinib-resistant or intolerant CML - Blast Crisis (BC) Group B - Imatinib and other TKI failure (arms 2, 3 and 4) * imatinib-resistant or intolerant CML - Chronic Phase (CP) * imatinib-resistant or intolerant CML - Accelerated Phase (AP) * imatinib-resistant or intolerant CML - Blast Crisis (BC) Hypereosinophilic syndrome/chronic eosinophilic leukemia (HES/CEL) (arm 5) Systemic mastocytosis (Sm) (arm 6)

Interventions

  • DRUG Nilotinib

Study Locations (20)

New York

  • Roswell Park Cancer Institute Rosewell SC — Buffalo
  • Memorial Sloan Kettering Cancer Center — New York
  • University of Rochester Medical Center — Rochester

California

  • City of Hope National Medical Center — Duarte
  • Stanford University Medical Center — Stanford

Illinois

  • University of Chicago Medical Center Dept. of U. of Chicago Hosp(3) — Chicago
  • University of Illinois at Chicago Divisionof Hematology/Oncology — Chicago

Michigan

  • University of Michigan Health System Clinical Trials Office — Ann Arbor
  • Wayne State University — Detroit

North Carolina

  • Duke University Medical Center — Durham
  • Wake Forest University Baptist Medical Center — Winston-Salem

Colorado

  • University of Colorado Hospital — Aurora

Florida

  • H. Lee Moffitt Cancer Center & Research Institute Dept.of H. Lee Moffitt — Tampa

Indiana

  • Indiana Blood and Marrow Institute Dept of Indiana Blood&Mar (2) — Beech Grove

Trial Details

FieldValue
Enrollment Target 507 participants
Start Date 2005-04
Est. Completion 2012-09
Phase Phase 1

Sponsor

Novartis Pharmaceuticals

792 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00109707

The ClinicalTrials.gov registry entry for NCT00109707 describes a study currently listed as completed. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 507 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Novartis Pharmaceuticals, which has 792 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 4 conditions, with Chronic Myelogenous Leukemia appearing as the primary indexed condition, and to 1 intervention — of which Nilotinib is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT00109707 reports 20 study locations spanning 14 distinct geographic areas — top geographies include New York, California, Illinois. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT00109707 about?

NCT00109707 is a clinical study titled "A Study of Oral AMN107 in Adults With Chronic Myelogenous Leukemia (CML) or Other Hematologic Malignancies". The purpose of this trial is to assess the efficacy, safety, tolerability, biologic activity, and pharmacokinetics of AMN107 in six groups of patients with one of the following conditions: Relapsed/refractory Ph+ Acute lymphoblastic leukemia (ALL) (arm 1) Group A - Imatinib failure only (arms 2, 3...

What is the current status of trial NCT00109707?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 507 participants. The study started on 2005-04. Estimated completion is 2012-09.

What conditions does trial NCT00109707 study?

This clinical trial studies the following conditions: Chronic Myelogenous Leukemia, Hypereosinophilic Syndrome, Systemic Mastocytosis, Acute Lymphoblastic Leukemia (Philadelphia Chromosome Positive). These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT00109707?

The interventions under investigation include: Nilotinib (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT00109707?

This trial is sponsored by Novartis Pharmaceuticals, which has 792 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT00109707 being conducted?

This trial has 20 study locations across California, Colorado, Florida, Illinois, Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

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