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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 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 659-participant average among 449 other Non-Small Cell Lung Cancer trials with a reported enrollment target (93% lower). The trial reports 1 study location across 1 state.

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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.

Interventions

  • DRUG Erlotinib
  • DRUG MEK162

Study Locations (1)

Florida

  • H. Lee Moffitt Cancer Center and Research Institute - Tampa

Trial Details

FieldValue
Enrollment Target 43 participants
Start Date 2013-12-30
Est. Completion 2019-08-22
Phase Phase 1

What the Registry Record Tells You About NCT01859026

The ClinicalTrials.gov registry entry for NCT01859026 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 43 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 659-participant average among 449 other Non-Small Cell Lung Cancer trials with a reported enrollment target (93% lower). The listed sponsor is H. Lee Moffitt Cancer Center and Research Institute, which has 502 total studies on file at ClinicalTrials.gov.

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 1 study location spanning 1 distinct geographic area - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.