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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 is a Phase 1 study that has completed, run by Millennium Pharmaceuticals. The registered enrollment target is 26 participants.
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
| Field | Value |
|---|---|
| Enrollment Target | 26 participants |
| Start Date | 2020-03-04 |
| Est. Completion | 2022-04-20 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04056455
The ClinicalTrials.gov registry entry for NCT04056455 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 26 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Millennium Pharmaceuticals, which has 135 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Mobocertinib is the first listed.
NCT04056455 reports 0 study locations.
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.
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