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NCT01859026 · ClinicalTrials.gov registry record · Phase 1
A Phase I/IB Trial of MEK162 in Combination With Erlotinib in NSCLC Harboring KRAS or EGFR Mutation
A Phase 1 study of Non-Small Cell Lung Cancer and Lung Cancer, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
- Completed
- Registry status
- Phase 1
- Development phase
- 43
- Enrollment target
- 1
- Study location
NCT01859026: Completed Phase 1 study of Non-Small Cell Lung Cancer and Lung Cancer, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
NCT01859026 is a Phase 1 study of Non-Small Cell Lung Cancer and Lung Cancer that has completed, run by H. Lee Moffitt Cancer Center and Research Institute. The registered enrollment target is 43 participants, below the 652-participant average among 454 other Non-Small Cell Lung Cancer trials with a reported enrollment target (93% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01859026, a Phase 1 study of Non-Small Cell Lung Cancer and Lung Cancer, has completed, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 43 participants
- Enrollment target
- 1
- Study location
Study Summary
The main purpose of this study is to find out if the drugs MEK162 and erlotinib (Tarceva) given in combination are safe and have beneficial effects in patients who have NSCLC. The U.S. Food and Drug Administration (FDA) has not approved MEK162 for use to treat NSCLC. Erlotinib is an FDA approved drug for the treatment of Non-Small Cell Lung Cancer.
Primary Outcome
To evaluate the safety of MEK162 plus erlotinib in patients with advanced NSCLC by evaluating toxicities of therapy and establish a recommended phase IB dosing of MEK162 and erlotinib. Safety population: consists of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.
Conditions Studied
Interventions
- DRUG Erlotinib
- DRUG MEK162
Study Locations (1)
Florida
- H. Lee Moffitt Cancer Center and Research Institute - Tampa
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 43 participants |
| Start Date | 2013-12-30 |
| Est. Completion | 2019-08-22 |
| Phase | Phase 1 |
What the finished NCT01859026 record still lists
NCT01859026 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 43 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 (93% 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 Erlotinib is the first listed.
NCT01859026 reports a single indexed study location in Florida.
Frequently Asked Questions
What is clinical trial NCT01859026 about?
NCT01859026 is a clinical study titled "A Phase I/IB Trial of MEK162 in Combination With Erlotinib in NSCLC Harboring KRAS or EGFR Mutation". The main purpose of this study is to find out if the drugs MEK162 and erlotinib (Tarceva) given in combination are safe and have beneficial effects in patients who have NSCLC. The U.S. Food and Drug Administration (FDA) has not approved MEK162 for use to treat NSCLC. Erlotinib is an FDA approved dr...
What is the current status of trial NCT01859026?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 43 participants. The study started on 2013-12-30. Estimated completion is 2019-08-22.
What conditions does trial NCT01859026 study?
This clinical trial studies the following conditions: Non-Small Cell Lung Cancer, Lung Cancer.
What interventions are being tested in trial NCT01859026?
The interventions under investigation include: Erlotinib (DRUG), MEK162 (DRUG).
Who is sponsoring clinical trial NCT01859026?
This trial is sponsored by H. Lee Moffitt Cancer Center and Research Institute, which has 502 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01859026 being conducted?
This trial has 1 study location across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT01859026's enrollment target sits among peer trials
43 349th of 454 higher than 104 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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