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NCT00109707 · ClinicalTrials.gov registry record · Phase 1
A Study of Oral AMN107 in Adults With Chronic Myelogenous Leukemia (CML) or Other Hematologic Malignancies
A Phase 1 study of Chronic Myelogenous Leukemia and Hypereosinophilic Syndrome, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 507
- Enrollment target
- 20
- Study locations
NCT00109707 is a Phase 1 study of Chronic Myelogenous Leukemia and Hypereosinophilic Syndrome that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 507 participants, above the 265-participant average among 29 other Chronic Myelogenous Leukemia trials with a reported enrollment target (91% higher). The trial reports 20 study locations across 14 states.
The verdict
NCT00109707, a Phase 1 study of Chronic Myelogenous Leukemia and Hypereosinophilic Syndrome, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 507 participants
- Enrollment target
- 20
- Study locations
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)
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 507 participants |
| Start Date | 2005-04 |
| Est. Completion | 2012-09 |
| Phase | Phase 1 |
Interested in This Trial?
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, categorized as Phase 1. The registered enrollment target is 507 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 265-participant average among 29 other Chronic Myelogenous Leukemia trials with a reported enrollment target (91% higher). The listed sponsor is Novartis Pharmaceuticals, which has 1,375 total studies on file at ClinicalTrials.gov.
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.
NCT00109707 reports 20 study locations spanning 14 distinct geographic areas - top geographies include New York, California, Illinois.
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).
What interventions are being tested in trial NCT00109707?
The interventions under investigation include: Nilotinib (DRUG).
Who is sponsoring clinical trial NCT00109707?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
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.
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