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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 is a Phase 1 study that was terminated before completion, run by Brown University. The registered enrollment target is 3 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03905889
The ClinicalTrials.gov registry entry for NCT03905889 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 3 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Brown University, which has 231 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Sunitinib is the first listed.
NCT03905889 reports 0 study locations.
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.
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