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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: Completed Phase 1 study of Chronic Myelogenous Leukemia and Hypereosinophilic Syndrome, sponsored by Novartis Pharmaceuticals.
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. According to ClinicalTrials.gov, the official US trial registry.
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)
Primary Outcome
Major Cytogenetic Response (MCyR) is defined as Complete Cytogenetic Response (CCyR: 0% Ph-chromosome-positive cells in metaphase in bone marrow) or Partial Cytogenetic Response (PCyR: 1-35% Ph-chromosome-positive cells in metaphase in bone marrow).
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 |
What the finished NCT00109707 record still lists
NCT00109707 is an interventional study that assigns participants to a tested intervention. The registered 507 participants enrollment target is mid-sized for trials with a published cap, above the 265-participant average among 29 other Chronic Myelogenous Leukemia trials with a reported enrollment target (91% higher).
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 names 20 study sites across 14 states, led by 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.
Learn More About Clinical Trials
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Where NCT00109707's enrollment target sits among peer trials
507 3rd of 29 higher than 27 of 29 other Chronic Myelogenous Leukemia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Chronic Myelogenous Leukemia trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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