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NCT02321540 · ClinicalTrials.gov registry record · Phase 1

A Phase I/II Study of Ibrutinib in Previously Treated Epidermal Growth Factor Receptor (EGFR) Mutant Non-Small Cell Lung Cancer

A Phase 1 study, sponsored by M.D. Anderson Cancer Center.

Completed
Registry status
Phase 1
Development phase
13
Enrollment target

NCT02321540: Completed Phase 1 study, sponsored by M.D. Anderson Cancer Center.

NCT02321540 is a Phase 1 study that has completed, run by M.D. Anderson Cancer Center. The registered enrollment target is 13 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (78% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02321540, a Phase 1 study, has completed, sponsored by M.D. Anderson Cancer Center.

COMPLETED
Registry status
Phase 1
Development phase
13 participants
Enrollment target

Study Summary

The goal of Part 1 of this clinical research study is to find the highest dose of (Imbruvica) ibrutinib that can be given to patients with non-small cell lung cancer (NSCLC). The goal of Part 2 of this clinical research study is to learn if the dose of ibrutinib found in Part 1 can help to control the disease. The safety of this drug will also be studied in both parts of the study.

Primary Outcome

Number of DLT observed at dose levels 560 (starting dose) and 840 mg PO daily to determine the MTD using the 3+3 design.

Interventions

  • DRUG Ibrutinib

Trial Details

FieldValue
Enrollment Target 13 participants
Start Date 2015-03-31
Est. Completion 2021-09-16
Phase Phase 1
M.D. Anderson Cancer Center

2,692 total trials

What the finished NCT02321540 record still lists

NCT02321540 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 13 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (78% lower).

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

NCT02321540 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02321540 about?

NCT02321540 is a clinical study titled "A Phase I/II Study of Ibrutinib in Previously Treated Epidermal Growth Factor Receptor (EGFR) Mutant Non-Small Cell Lung Cancer". The goal of Part 1 of this clinical research study is to find the highest dose of (Imbruvica) ibrutinib that can be given to patients with non-small cell lung cancer (NSCLC). The goal of Part 2 of this clinical research study is to learn if the dose of ibrutinib found in Part 1 can help to control t...

What is the current status of trial NCT02321540?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 13 participants. The study started on 2015-03-31. Estimated completion is 2021-09-16.

What interventions are being tested in trial NCT02321540?

The interventions under investigation include: Ibrutinib (DRUG).

Who is sponsoring clinical trial NCT02321540?

This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT02321540's enrollment target sits among peer trials

13 1847th of 2000 higher than 149 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 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.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT02321540, the US trial registry maintained by the National Library of Medicine. NCT02321540 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.