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NCT01828112 · ClinicalTrials.gov registry record · Phase 3
LDK378 Versus Chemotherapy in ALK Rearranged (ALK Positive) Patients Previously Treated With Chemotherapy (Platinum Doublet) and Crizotinib
A Phase 3 study of Non-Small Cell Lung Cancer, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 231
- Enrollment target
- 20
- Study locations
NCT01828112: Completed Phase 3 study of Non-Small Cell Lung Cancer, sponsored by Novartis Pharmaceuticals.
NCT01828112 is a Phase 3 study of Non-Small Cell Lung Cancer that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 231 participants, below the 652-participant average among 454 other Non-Small Cell Lung Cancer trials with a reported enrollment target (65% lower). The trial reports 20 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01828112, a Phase 3 study of Non-Small Cell Lung Cancer, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 231 participants
- Enrollment target
- 20
- Study locations
Study Summary
The primary purpose of the study was to compare the antitumor activity of LDK378 vs. chemotherapy in patients previously treated with chemotherapy (platinum doublet) and crizotinib. Patients in the chemotherapy arm were given the option to switch to LDK378 after confirmed progressive disease (PD), while also had the choice to continue with pemetrexed treatment.
Primary Outcome
PFS was defined as the time from the date of randomization to the date of the first radiologically documented disease progression or death due to any cause.
Conditions Studied
Interventions
- DRUG Docetaxel
- DRUG Pemetrexed
- DRUG Ceritinib
Study Locations (20)
Other
- Novartis Investigative Site - Brussels
- Novartis Investigative Site - Brussels
- Novartis Investigative Site - Edegem
- Novartis Investigative Site - Leuven
- Novartis Investigative Site - Besançon
Florida
- Memorial Cancer Institute - Hollywood
- Cancer Specialists of North Florida - Jacksonville
- University Of Miami - Miami
Texas
- Texas Oncology-Sugarland - Sugar Land
- Texas Oncology Cancer Care and Research Center - Waco
Arkansas
- Highlands Oncology Group - Fayetteville
Illinois
- Loyola University Medical Center - Marywood
Iowa
- Uni Of Iowa Hospitals And Clinics - Iowa City
Massachusetts
- Massachusetts General Hospital - Boston
Oklahoma
- Oklahoma Cancer Specialists and Research Institute - Tulsa
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 231 participants |
| Start Date | 2013-06-28 |
| Est. Completion | 2023-11-10 |
| Phase | Phase 3 |
What the finished NCT01828112 record still lists
NCT01828112 is an interventional study that assigns participants to a tested intervention. The registered 231 participants enrollment target is mid-sized for trials with a published cap, below the 652-participant average among 454 other Non-Small Cell Lung Cancer trials with a reported enrollment target (65% lower).
The record links to 1 condition, with Non-Small Cell Lung Cancer appearing as the primary indexed condition, and to 3 interventions - of which Docetaxel is the first listed.
NCT01828112 names 20 study sites across 13 states, led by Other, Florida, Texas.
Frequently Asked Questions
What is clinical trial NCT01828112 about?
NCT01828112 is a clinical study titled "LDK378 Versus Chemotherapy in ALK Rearranged (ALK Positive) Patients Previously Treated With Chemotherapy (Platinum Doublet) and Crizotinib". The primary purpose of the study was to compare the antitumor activity of LDK378 vs. chemotherapy in patients previously treated with chemotherapy (platinum doublet) and crizotinib. Patients in the chemotherapy arm were given the option to switch to LDK378 after confirmed progressive disease (PD), w...
What is the current status of trial NCT01828112?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 231 participants. The study started on 2013-06-28. Estimated completion is 2023-11-10.
What conditions does trial NCT01828112 study?
This clinical trial studies the following conditions: Non-Small Cell Lung Cancer.
What interventions are being tested in trial NCT01828112?
The interventions under investigation include: Docetaxel (DRUG), Pemetrexed (DRUG), Ceritinib (DRUG).
Who is sponsoring clinical trial NCT01828112?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01828112 being conducted?
This trial has 20 study locations across Arkansas, Florida, Illinois, Iowa, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT01828112's enrollment target sits among peer trials
231 155th of 454 higher than 300 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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