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NCT01283516 · ClinicalTrials.gov registry record · Phase 1
A Dose Escalation/Expansion Study of LDK378 in Patients With Tumors Characterized by Genetic Abnormalities in Anaplastic Lymphoma Kinase
A Phase 1 study of Tumors Characterized by Genetic Abnormalities of ALK, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 304
- Enrollment target
- 20
- Study locations
NCT01283516 is a Phase 1 study of Tumors Characterized by Genetic Abnormalities of ALK that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 304 participants. The trial reports 20 study locations across 14 states.
The verdict
NCT01283516, a Phase 1 study of Tumors Characterized by Genetic Abnormalities of ALK, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 304 participants
- Enrollment target
- 20
- Study locations
Study Summary
This study assessed the safety and efficacy of LDK378 in adult patients with genetic abnormalities in anaplastic lymphoma kinase (ALK).
Conditions Studied
Interventions
- DRUG LDK378
Study Locations (20)
Other
- Novartis Investigative Site - Leuven
- Novartis Investigative Site - Essen
- Novartis Investigative Site - Heidelberg
- Novartis Investigative Site - Ulm
- Novartis Investigative Site - Amsterdam
- Novartis Investigative Site - Singapore
MI
- Novartis Investigative Site - Milan
- Novartis Investigative Site - Rozzano
Colorado
- University of Colorado School of Medicine Colorado Univ - Aurora
Massachusetts
- Massachusetts General Hospital Mass General - Boston
New York
- Memorial Sloan Kettering MSK - New York
Pennsylvania
- Fox Chase Cancer Center Fox Chase Cancer (2) - Philadelphia
Utah
- University of Utah / Huntsman Cancer Institute Huntsman - Salt Lake City
Washington
- Seattle Cancer Care Alliance - Seattle
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 304 participants |
| Start Date | 2011-01-24 |
| Est. Completion | 2016-05-03 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01283516
The ClinicalTrials.gov registry entry for NCT01283516 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 304 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 Tumors Characterized by Genetic Abnormalities of ALK appearing as the primary indexed condition, and to 1 intervention - of which LDK378 is the first listed.
NCT01283516 reports 20 study locations spanning 14 distinct geographic areas - top geographies include Other, MI, Colorado.
Frequently Asked Questions
What is clinical trial NCT01283516 about?
NCT01283516 is a clinical study titled "A Dose Escalation/Expansion Study of LDK378 in Patients With Tumors Characterized by Genetic Abnormalities in Anaplastic Lymphoma Kinase". This study assessed the safety and efficacy of LDK378 in adult patients with genetic abnormalities in anaplastic lymphoma kinase (ALK).
What is the current status of trial NCT01283516?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 304 participants. The study started on 2011-01-24. Estimated completion is 2016-05-03.
What conditions does trial NCT01283516 study?
This clinical trial studies the following conditions: Tumors Characterized by Genetic Abnormalities of ALK.
What interventions are being tested in trial NCT01283516?
The interventions under investigation include: LDK378 (DRUG).
Who is sponsoring clinical trial NCT01283516?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01283516 being conducted?
This trial has 20 study locations across Colorado, Massachusetts, New York, Pennsylvania, Utah. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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