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NCT03905889 · ClinicalTrials.gov registry record · Phase 1
A Study of Abemaciclib in Combination With Sunitinib in Metastatic Renal Cell Carcinoma
A Phase 1 study, sponsored by Brown University.
- Terminated
- Registry status
- Phase 1
- Development phase
- 3
- Enrollment target
NCT03905889: Clinical Trial Phase 1 study, sponsored by Brown University.
NCT03905889 is a Phase 1 study that was terminated before completion, run by Brown University. 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.
The verdict
NCT03905889, a Phase 1 study, was terminated before completion, sponsored by Brown University.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 3 participants
- Enrollment target
Study Summary
The purpose of this study is to determine the safety, tolerability, and maximal tolerated dose (MTD) of the combination of Abemaciclib and Sunitinib administered orally in patients with advanced and metastatic renal cell carcinoma. This study consists of two parts: Dose Escalation and Dose Expansion. During the dose escalation phase, participants will be sequentially enrolled in a standard 3 x 3 dose escalation study design to receive oral Abemaciclib in Combination with Sunitinib. The purpose of this dose escalation is to determine the maximal tolerated dose based on assessment of any dose limiting toxicity. The Dose Expansion Phase will enroll additional participants at the established maximal tolerated dose to further evaluate safety, tolerability, as well as the pharmacokinetics and pharmacodynamics of this combination drug regimen.
Primary Outcome
A standard 3+3 trial design will be used to determine the safest maximal tolerated dose of the combination of Abemaciclib with Sunitinib. Doses of each medication will be increased or decreased based on upon tolerability and assessment of any dose limiting toxicity(ies) that may occur in study subjects. Safety and toxicity will be evaluated using the NCI Common Toxicity Criteria.
Interventions
- DRUG Sunitinib
- DRUG Abemaciclib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3 participants |
| Start Date | 2019-06-05 |
| Est. Completion | 2022-03-08 |
| Phase | Phase 1 |
Why NCT03905889 stopped before completion
NCT03905889 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 Sunitinib is the first listed.
NCT03905889 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03905889 about?
NCT03905889 is a clinical study titled "A Study of Abemaciclib in Combination With Sunitinib in Metastatic Renal Cell Carcinoma". The purpose of this study is to determine the safety, tolerability, and maximal tolerated dose (MTD) of the combination of Abemaciclib and Sunitinib administered orally in patients with advanced and metastatic renal cell carcinoma. This study consists of two parts: Dose Escalation and Dose Expansion...
What is the current status of trial NCT03905889?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 3 participants. The study started on 2019-06-05. Estimated completion is 2022-03-08.
What interventions are being tested in trial NCT03905889?
The interventions under investigation include: Sunitinib (DRUG), Abemaciclib (DRUG).
Who is sponsoring clinical trial NCT03905889?
This trial is sponsored by Brown University, which has 231 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03905889'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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