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Completed Phase 1Phase 2 Interventional Results available

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

ClinicalTrials.gov ID: NCT00109707

Public ClinicalTrials.gov record NCT00109707. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 27, 2026, 11:52 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Phase IA/II Multicenter, Dose-escalation Study of Oral AMN107 on a Continuous Daily Dosing Schedule in Adult Patients With Imatinib-resistant/Intolerant CML in Chronic or Accelerated Phase or Blast Crisis, Relapsed/Refractory Ph+ ALL, and Other Hematologic Malignancies.

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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)

Study identification

NCT ID
NCT00109707
Recruitment status
Completed
Study type
Interventional
Phase
Phase 1, Phase 2
Lead sponsor
Novartis Pharmaceuticals
Industry
Enrollment
507 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Apr 2005 (Actual)
Primary completion
Sep 2012 (Actual)
Completion
Sep 2012 (Actual)
Last update posted
Jun 29, 2021

2005 – 2012

United States locations

U.S. sites
24
U.S. states
17
U.S. cities
23
Facility City State ZIP Site status
City of Hope National Medical Center Duarte California 91010 —
Stanford University Medical Center Stanford California 94305-5750 —
University of Colorado Hospital Aurora Colorado 80045 —
H. Lee Moffitt Cancer Center & Research Institute Dept.of H. Lee Moffitt Tampa Florida 33612 —
University of Chicago Medical Center Dept. of U. of Chicago Hosp(3) Chicago Illinois 60637 —
University of Illinois at Chicago Divisionof Hematology/Oncology Chicago Illinois — —
Indiana Blood and Marrow Institute Dept of Indiana Blood&Mar (2) Beech Grove Indiana 46107 —
Ochsner Clinic Foundation New Orleans Louisiana 70121 —
Sidney Kimmel Comprehensive Cancer Center/Johns Hopkins Med. Div.of Hematologic Malignancie Baltimore Maryland 21231 —
Dana Farber Cancer Institute Boston Massachusetts 02115 —
University of Michigan Health System Clinical Trials Office Ann Arbor Michigan 48109 —
Wayne State University Detroit Michigan 48201 —
Mayo Clinic - Rochester Rochester Minnesota 55905 —
Hackensack University Medical Center Hackensack New Jersey 07601 —
Roswell Park Cancer Institute Rosewell SC Buffalo New York 14263 —
Memorial Sloan Kettering Cancer Center New York New York 10017 —
University of Rochester Medical Center Rochester New York 14642 —
Duke University Medical Center Durham North Carolina 27710 —
Wake Forest University Baptist Medical Center Winston-Salem North Carolina 27157 —
Oregon Health Sciences University Portland Oregon 97239 —
The Jones Clinic Germantown Tennessee 38138 —
Vanderbilt University Medical Center, Clinical Trials Center Investigational Drug Services Nashville Tennessee 37212 —
MD Anderson Cancer Center/University of Texas Houston Texas 77030 —
Swedish Cancer Institute Seattle Washington 98104 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 77 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00109707, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jun 29, 2021 · Synced Oct 27, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT00109707 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →