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Can extended poziotinib use keep cancer in check?

NCT ID NCT03744715

Disease control Sponsor: Spectrum Pharmaceuticals, Inc Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 28, 2026 · Last updated Jul 29, 2026 · Updated 1 time

Summary

This trial offers continued treatment with poziotinib for people with non-small cell lung cancer or breast cancer who have already benefited from the drug in a previous study. The goal is to monitor safety and see how long the cancer remains controlled with extended use. Only patients whose doctors believe they are still gaining clinical benefit can join.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
poziotinib
What this could lead to
If successful, this could provide a way for patients who respond to poziotinib to keep receiving it for longer, potentially extending disease control.
What could go wrong
This is a small, open-label extension study with only 7 participants, so results may not apply broadly. Poziotinib can cause side effects like rash and diarrhea.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

7 people

The number who actually took part.

Started

Oct 2018

Finished

Mar 2023

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Patient has had previous exposure to poziotinib and is still receiving clinical benefit from treatment, as judged by the Investigator or treating physician. * Patient must have completed the End of Treatment or End of Study visit if enrolled in a previous (original) poziotinib study. * Investigator or treating physician opinion indicates that extended therapy with poziotinib is clinically appropriate for the patient and the patient is suitable for this Study. * Patient agrees to continue study treatment. * Patient must provide written Informed Consent, must be able to adhere to dosing and visit schedules, and meet protocol-defined study requirements. * Patient is willing to practice 2 forms of contraception, one of which must be a barrier method, from study entry until at least 30 days after the last dose of poziotinib. Exclusion Criteria: * Patient has any ongoing adverse event that hasn't improved to Grade ≤1 and could impact the patient's tolerability to poziotinib. * Patient has an active uncontrolled infection, bleeding disorder, underlying medical condition, or other serious illness that would impair the ability of the patient to receive poziotinib. * Patient has any medical or non-medical condition that may not be suitable for poziotinib treatment, as determined by the investigator or treating physician. * Patient last dose of poziotinib was more than 28 days prior to Day 1 of the study. * Patient is pregnant or breastfeeding.

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Conditions

The condition(s) this trial relates to.

breast cancer breast neoplasm non-small cell lung carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Breast cancer NSCLC

Contacts and locations

Locations

  • Hattiesburg Clinic Hematology Oncology

    Hattiesburg, Mississippi, 39401, United States

  • Laura and Isaac Perlmutter Cancer Center at NYU Langone

    New York, New York, 10016, United States

  • Pacific Shores Medical Group

    Long Beach, California, 90813, United States

  • UPMC

    Pittsburgh, Pennsylvania, 15232, United States

  • UT MD Anderson Cancer Center

    Houston, Texas, 77030, United States

More trials for these conditions

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