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NCT03814005 · ClinicalTrials.gov registry record · Phase 1
A Study of Pevonedistat in People With Blood Cancers or Solid Tumors With Kidney or Liver Problems
A Phase 1 study, sponsored by Takeda.
- Completed
- Registry status
- Phase 1
- Development phase
- 17
- Enrollment target
NCT03814005 is a Phase 1 study that has completed, run by Takeda. The registered enrollment target is 17 participants.
The verdict
NCT03814005, a Phase 1 study, has completed, sponsored by Takeda.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 17 participants
- Enrollment target
Study Summary
Pevonedistat is a medicine to treat people with blood cancers or solid tumors. The main aim of the study is to learn about the levels of pevonedistat in the blood of participants with blood cancers or solid tumors, who also have severe kidney problems or mild to moderate liver problems. The information from this study will be used to work out the best dose of pevonedistat to give people with these conditions in future studies. At the first visit, the study doctor will check who can take part in the study. This study is in 2 parts: A and B. Part A Participants will be placed into 1 of 4 treatment groups depending on how severe their kidney and liver problems are. All participants will receive 1 dose of pevonedistat as a slow injection in their vein (infusion). Then, the study doctors will check the levels of pevonedistat in the blood of the participants for 3 days after the infusion. They will also check if the participants have any side effects from pevonedistat. Participants will be asked to continue to Part B. Those who don't want to continue will visit the clinic 30 days later for a final check-up. Part B Participants who agree to participate into Part B will receive an infusion of pevonedistat on specific days during a 21-day or 28-day cycle. The cycle time will depend on what type of cancer the participants have. Participants will also be treated with standard of care medicines for their kidney and liver problems during this time. In the first cycle, the study doctors will also check the levels of pevonedistat in the blood and urine of participants for 3 days after the infusion. Participants will continue with cycles of treatment together with standard of care medicines until their condition gets worse or they have too many side effects from the treatment. When treatment has finished, participants will visit the clinic 10 days later for a final check-up.
Interventions
- DRUG Azacitidine
- DRUG Pevonedistat
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 17 participants |
| Start Date | 2019-07-10 |
| Est. Completion | 2022-04-19 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03814005
The ClinicalTrials.gov registry entry for NCT03814005 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 17 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Takeda, which has 408 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Azacitidine is the first listed.
NCT03814005 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03814005 about?
NCT03814005 is a clinical study titled "A Study of Pevonedistat in People With Blood Cancers or Solid Tumors With Kidney or Liver Problems". Pevonedistat is a medicine to treat people with blood cancers or solid tumors. The main aim of the study is to learn about the levels of pevonedistat in the blood of participants with blood cancers or solid tumors, who also have severe kidney problems or mild to moderate liver problems. The informa...
What is the current status of trial NCT03814005?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 17 participants. The study started on 2019-07-10. Estimated completion is 2022-04-19.
What interventions are being tested in trial NCT03814005?
The interventions under investigation include: Azacitidine (DRUG), Pevonedistat (DRUG).
Who is sponsoring clinical trial NCT03814005?
This trial is sponsored by Takeda, which has 408 total clinical trials registered on ClinicalTrials.gov.
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