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NCT04005144 · ClinicalTrials.gov registry record · Phase 1

Brigatinib and Binimetinib in Treating Patients With Stage IIIB-IV ALK or ROS1-Rearranged Non-small Cell Lung Cancer

A Phase 1 study, sponsored by University of California, San Francisco.

Terminated
Registry status
Phase 1
Development phase
3
Enrollment target

NCT04005144: Clinical Trial Phase 1 study, sponsored by University of California, San Francisco.

NCT04005144 is a Phase 1 study that was terminated before completion, run by University of California, San Francisco. The registered enrollment target is 3 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04005144, a Phase 1 study, was terminated before completion, sponsored by University of California, San Francisco.

TERMINATED
Registry status
Phase 1
Development phase
3 participants
Enrollment target

Study Summary

This phase I trial studies the side effects and best dose of brigatinib and binimetinib in treating patients with stage IIIB-IV non-small cell lung cancer and a type of gene mutation called a rearrangement in the ALK or ROS1 genes. Brigatinib and binimetinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Primary Outcome

Evaluating the number and frequency of adverse events as determined by the National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI-CTCAE) version (v)5.0 by investigator's assessment will be used to determine the recommended phase 2 dose for future studies.

Interventions

  • DRUG Binimetinib
  • DRUG Brigatinib

Trial Details

FieldValue
Enrollment Target 3 participants
Start Date 2020-02-25
Est. Completion 2022-10-01
Phase Phase 1

Why NCT04005144 stopped before completion

NCT04005144 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 3 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (95% lower).

The record links to 0 conditions, and to 2 interventions - of which Binimetinib is the first listed.

NCT04005144 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT04005144 about?

NCT04005144 is a clinical study titled "Brigatinib and Binimetinib in Treating Patients With Stage IIIB-IV ALK or ROS1-Rearranged Non-small Cell Lung Cancer". This phase I trial studies the side effects and best dose of brigatinib and binimetinib in treating patients with stage IIIB-IV non-small cell lung cancer and a type of gene mutation called a rearrangement in the ALK or ROS1 genes. Brigatinib and binimetinib may stop the growth of tumor cells by blo...

What is the current status of trial NCT04005144?

This trial is currently terminated. It is a Phase 1 study. The enrollment target is 3 participants. The study started on 2020-02-25. Estimated completion is 2022-10-01.

What interventions are being tested in trial NCT04005144?

The interventions under investigation include: Binimetinib (DRUG), Brigatinib (DRUG).

Who is sponsoring clinical trial NCT04005144?

This trial is sponsored by University of California, San Francisco, which has 1,713 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT04005144's enrollment target sits among peer trials

3 1999th of 2000 higher than 1 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 NCT04005144, the US trial registry maintained by the National Library of Medicine. NCT04005144 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.