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NCT01967095 · ClinicalTrials.gov registry record · Phase 1

Low Dose Daily Erlotinib in Combination With High Dose Twice Weekly Erlotinib in Patients With EGFR-Mutant Lung Cancer

A Phase 1 study, sponsored by Memorial Sloan Kettering Cancer Center.

Completed
Registry status
Phase 1
Development phase
53
Enrollment target

NCT01967095: Completed Phase 1 study, sponsored by Memorial Sloan Kettering Cancer Center.

NCT01967095 is a Phase 1 study that has completed, run by Memorial Sloan Kettering Cancer Center. The registered enrollment target is 53 participants. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01967095, a Phase 1 study, has completed, sponsored by Memorial Sloan Kettering Cancer Center.

COMPLETED
Registry status
Phase 1
Development phase
53 participants
Enrollment target

Study Summary

The purpose of this study is to test the safety of different ways of taking erlotinib. The investigators want to find out what effects, good and/or bad, combination daily low dose and twice weekly high dose erlotinib has on the patient and lung cancer. The investigators are also seeing whether different schedules of erlotinib are better at treating lung cancer that has spread to the central nervous system. CNS expansion phase: The pulse continuous regimen will be then assess in patients with EGFR mutant lung cancers and CNS involvement. An additional expansion cohort (A) will enroll 19 patients with newly diagnosed EGFR mutant lung cancer with CNS involvement at diagnosis. The patients in the expansion cohorts will undergo the same treatment plan as the patients in the dose expansion cohort. A patient in the expansion cohorts will not be replaced if he/she does not finish the first 28 day (cycle 1) treatment period.

Interventions

  • DRUG erlotinib

Trial Details

FieldValue
Enrollment Target 53 participants
Start Date 2013-10-15
Est. Completion 2018-11-08
Phase Phase 1

Sponsor

Memorial Sloan Kettering Cancer Center

1,884 total trials

What the Registry Record Tells You About NCT01967095

The ClinicalTrials.gov registry entry for NCT01967095 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 53 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Memorial Sloan Kettering Cancer Center, which has 1,884 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 1 intervention - of which erlotinib is the first listed.

NCT01967095 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT01967095 about?

NCT01967095 is a clinical study titled "Low Dose Daily Erlotinib in Combination With High Dose Twice Weekly Erlotinib in Patients With EGFR-Mutant Lung Cancer". The purpose of this study is to test the safety of different ways of taking erlotinib. The investigators want to find out what effects, good and/or bad, combination daily low dose and twice weekly high dose erlotinib has on the patient and lung cancer. The investigators are also seeing whether diffe...

What is the current status of trial NCT01967095?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 53 participants. The study started on 2013-10-15. Estimated completion is 2018-11-08.

What interventions are being tested in trial NCT01967095?

The interventions under investigation include: erlotinib (DRUG).

Who is sponsoring clinical trial NCT01967095?

This trial is sponsored by Memorial Sloan Kettering Cancer Center, which has 1,884 total clinical trials registered on ClinicalTrials.gov.

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

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, the data changelog, or report a data error.