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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: Completed Phase 1 study of Tumors Characterized by Genetic Abnormalities of ALK, sponsored by Novartis Pharmaceuticals.
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, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (407% higher). The trial reports 20 study locations across 14 states. According to ClinicalTrials.gov, the official US trial registry.
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).
Primary Outcome
The maximum tolerated dose (MTD) was defined as the highest dose for a given schedule that was expected to cause DLTs in no more than 33% of patients during the first cycle of treatment. A patient with multiple occurrences of a DLT under one treatment is counted only once in the AE category for that treatment. MTD was determined at 750mg.
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 |
What the finished NCT01283516 record still lists
NCT01283516 is an interventional study that assigns participants to a tested intervention. The registered 304 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (407% higher).
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 names 20 study sites across 14 states, led by 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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01283516's enrollment target sits among peer trials
304 124th of 2000 higher than 1,877 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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