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NCT01844765 · ClinicalTrials.gov registry record · Phase 2
Open Label, Phase II Study to Evaluate Efficacy and Safety of Oral Nilotinib in Philadelphia Positive (Ph+) Chronic Myelogenous Leukemia (CML) Pediatric Patients.
A Phase 2 study of Philadelphia Positive (Ph+) Chronic Myelogenous Leukemia, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 59
- Enrollment target
- 20
- Study locations
NCT01844765 is a Phase 2 study of Philadelphia Positive (Ph+) Chronic Myelogenous Leukemia that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 59 participants. The trial reports 20 study locations across 14 states.
The verdict
NCT01844765, a Phase 2 study of Philadelphia Positive (Ph+) Chronic Myelogenous Leukemia, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 59 participants
- Enrollment target
- 20
- Study locations
Study Summary
To evaluate the safety, efficacy and pharmacokinetics of nilotinib over time in the Ph+ chronic myelogenous leukemia (CML) in pediatric patients (from 1 to \<18 years).
Conditions Studied
Interventions
- DRUG nilotinib
Study Locations (20)
Other
- Novartis Investigative Site - Lille
- Novartis Investigative Site - Paris
- Novartis Investigative Site - Poitiers
- Novartis Investigative Site - Budapest
California
- Loma Linda University Cancer Center - Loma Linda
- Lucile Salter Packard Children's Hospital at Stanford - Palo Alto
Florida
- Nemours Childrens Hospital - Orlando
- St. Mary's Hospital - West Palm Beach
Texas
- University of Texas Southwestern Medical Center Oncology - Dallas
- Cook Children's Medical Center Oncology - Fort Worth
Maryland
- Johns Hopkins Oncology Center ORA - Baltimore
North Carolina
- UNC Chapel Hill - Chapel Hill
Ohio
- Nationwide Childrens Hospital - Columbus
Washington
- Seattle Childrens Hospital - Seattle
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 59 participants |
| Start Date | 2013-08-20 |
| Est. Completion | 2020-08-28 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01844765
The ClinicalTrials.gov registry entry for NCT01844765 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 59 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Novartis Pharmaceuticals, which has 1,375 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Philadelphia Positive (Ph+) Chronic Myelogenous Leukemia appearing as the primary indexed condition, and to 1 intervention - of which nilotinib is the first listed.
NCT01844765 reports 20 study locations spanning 14 distinct geographic areas - top geographies include Other, California, Florida.
Frequently Asked Questions
What is clinical trial NCT01844765 about?
NCT01844765 is a clinical study titled "Open Label, Phase II Study to Evaluate Efficacy and Safety of Oral Nilotinib in Philadelphia Positive (Ph+) Chronic Myelogenous Leukemia (CML) Pediatric Patients.". To evaluate the safety, efficacy and pharmacokinetics of nilotinib over time in the Ph+ chronic myelogenous leukemia (CML) in pediatric patients (from 1 to \<18 years).
What is the current status of trial NCT01844765?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 59 participants. The study started on 2013-08-20. Estimated completion is 2020-08-28.
What conditions does trial NCT01844765 study?
This clinical trial studies the following conditions: Philadelphia Positive (Ph+) Chronic Myelogenous Leukemia.
What interventions are being tested in trial NCT01844765?
The interventions under investigation include: nilotinib (DRUG).
Who is sponsoring clinical trial NCT01844765?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01844765 being conducted?
This trial has 20 study locations across California, Florida, Maryland, North Carolina, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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