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NCT04056455 · ClinicalTrials.gov registry record · Phase 1

A Study of Mobocertinib Capsules in People With Severe Kidney Problems and People With Healthy Kidneys

A Phase 1 study, sponsored by Millennium Pharmaceuticals.

Completed
Registry status
Phase 1
Development phase
26
Enrollment target

NCT04056455: Completed Phase 1 study, sponsored by Millennium Pharmaceuticals.

NCT04056455 is a Phase 1 study that has completed, run by Millennium Pharmaceuticals. The registered enrollment target is 26 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (57% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04056455, a Phase 1 study, has completed, sponsored by Millennium Pharmaceuticals.

COMPLETED
Registry status
Phase 1
Development phase
26 participants
Enrollment target

Study Summary

It is hoped that mobocertinib will eventually help people with cancer with severely reduced kidney function. The main aim of this study is to learn about the levels of mobocertinib in the blood and urine of participants with severely reduced kidney function and participants with healthy kidneys. These participants do not have cancer. The information from this study will be used to work out the best dose of mobocertinib for people with cancer with severely reduced kidney function in the future. At the first visit, the study doctor will check who can take part. Participants who can take part will be placed into 1 of 2 treatment groups. Participants with severely reduced kidney function will be in 1 group. Participants with healthy kidneys will be in the other group. Participants in both groups will receive the same treatment and the group results will be compared. Participants from both groups will take 1 capsule of mobocertinib. They will stay in the clinic for 10 days so the study doctors can check the amount of mobocertinib in the blood and urine of these participants over time. The study doctors will also check if the participants have any side effects from this treatment. The clinic will call the participants 30 days after they took mobocertinib to check if they have any more side effects from their treatment.

Interventions

  • DRUG Mobocertinib

Trial Details

FieldValue
Enrollment Target 26 participants
Start Date 2020-03-04
Est. Completion 2022-04-20
Phase Phase 1
Millennium Pharmaceuticals

135 total trials

What the finished NCT04056455 record still lists

NCT04056455 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 26 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (57% lower).

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

NCT04056455 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT04056455 about?

NCT04056455 is a clinical study titled "A Study of Mobocertinib Capsules in People With Severe Kidney Problems and People With Healthy Kidneys". It is hoped that mobocertinib will eventually help people with cancer with severely reduced kidney function. The main aim of this study is to learn about the levels of mobocertinib in the blood and urine of participants with severely reduced kidney function and participants with healthy kidneys. The...

What is the current status of trial NCT04056455?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 26 participants. The study started on 2020-03-04. Estimated completion is 2022-04-20.

What interventions are being tested in trial NCT04056455?

The interventions under investigation include: Mobocertinib (DRUG).

Who is sponsoring clinical trial NCT04056455?

This trial is sponsored by Millennium Pharmaceuticals, which has 135 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT04056455's enrollment target sits among peer trials

26 1482nd of 2000 higher than 506 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 NCT04056455, the US trial registry maintained by the National Library of Medicine. NCT04056455 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.