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NCT01772797 · ClinicalTrials.gov registry record · Phase 1
Phase Ib Study of LDK378 and AUY922 in ALK-rearranged Non-small Cell Lung Cancer
A Phase 1 study of Non-Small Cell Lung Cancer and Anaplastic Lymphoma Kinase (ALK), sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 22
- Enrollment target
- 8
- Study locations
NCT01772797: Completed Phase 1 study of Non-Small Cell Lung Cancer and Anaplastic Lymphoma Kinase (ALK), sponsored by Novartis Pharmaceuticals.
NCT01772797 is a Phase 1 study of Non-Small Cell Lung Cancer and Anaplastic Lymphoma Kinase (ALK) that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 22 participants, below the 652-participant average among 454 other Non-Small Cell Lung Cancer trials with a reported enrollment target (97% lower). The trial reports 8 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01772797, a Phase 1 study of Non-Small Cell Lung Cancer and Anaplastic Lymphoma Kinase (ALK), has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 22 participants
- Enrollment target
- 8
- Study locations
Study Summary
The primary purpose of the study is to estimate the maximum tolerated dose of the combination of LDK378 and AUY922. This study will assess the safety, tolerability, pharmacokinetics and preliminary evidence of anti-tumor activity of the combination of LDK378 and AUY922 in ALK-rearranged non-small cell lung cancer.
Primary Outcome
cycle = within the first 28 days of patient's first dose
Conditions Studied
Interventions
- DRUG LDK378
- DRUG AUY922
Study Locations (8)
Colorado
- University of Colorado Dept. of Anschutz Cancer (3) - Aurora
Massachusetts
- Massachusetts General Hospital Mass General - Boston
Pennsylvania
- Fox Chase Cancer Center Fox Chase Cancer (2) - Philadelphia
Utah
- University of Utah / Huntsman Cancer Institute Huntsman - Salt Lake City
Victoria
- Novartis Investigative Site - Melbourne
MI
- Novartis Investigative Site - Milan
Other
- Novartis Investigative Site - Singapore
Catalonia
- Novartis Investigative Site - Barcelona
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 22 participants |
| Start Date | 2013-06 |
| Est. Completion | 2016-01 |
| Phase | Phase 1 |
What the finished NCT01772797 record still lists
NCT01772797 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 22 participants, a relatively small participant target, below the 652-participant average among 454 other Non-Small Cell Lung Cancer trials with a reported enrollment target (97% lower).
The record links to 2 conditions, with Non-Small Cell Lung Cancer appearing as the primary indexed condition, and to 2 interventions - of which LDK378 is the first listed.
NCT01772797 lists 8 locations in 8 states (Colorado, Massachusetts, Pennsylvania).
Frequently Asked Questions
What is clinical trial NCT01772797 about?
NCT01772797 is a clinical study titled "Phase Ib Study of LDK378 and AUY922 in ALK-rearranged Non-small Cell Lung Cancer". The primary purpose of the study is to estimate the maximum tolerated dose of the combination of LDK378 and AUY922. This study will assess the safety, tolerability, pharmacokinetics and preliminary evidence of anti-tumor activity of the combination of LDK378 and AUY922 in ALK-rearranged non-small ce...
What is the current status of trial NCT01772797?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 22 participants. The study started on 2013-06. Estimated completion is 2016-01.
What conditions does trial NCT01772797 study?
This clinical trial studies the following conditions: Non-Small Cell Lung Cancer, Anaplastic Lymphoma Kinase (ALK).
What interventions are being tested in trial NCT01772797?
The interventions under investigation include: LDK378 (DRUG), AUY922 (DRUG).
Who is sponsoring clinical trial NCT01772797?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01772797 being conducted?
This trial has 8 study locations across Colorado, Massachusetts, Pennsylvania, Utah, Victoria. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT01772797's enrollment target sits among peer trials
22 414th of 454 higher than 40 of 454 other Non-Small Cell Lung Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Non-Small Cell Lung Cancer 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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