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NCT01100619 · ClinicalTrials.gov registry record · Phase 1
A Drug-Drug Interaction Study of the Effects of XL184 (Cabozantinib) on Rosiglitazone in Subjects With Solid Tumors
A Phase 1 study, sponsored by Exelixis.
- Completed
- Registry status
- Phase 1
- Development phase
- 40
- Enrollment target
NCT01100619 is a Phase 1 study that has completed, run by Exelixis. The registered enrollment target is 40 participants.
The verdict
NCT01100619, a Phase 1 study, has completed, sponsored by Exelixis.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 40 participants
- Enrollment target
Study Summary
The primary objective of this clinical study is to determine whether the inhibition of cytochrome P450 (CYP) isozyme CYP2C8 by XL184 observed in in vitro preclinical studies translates into the potential for clinically significant drug-drug interactions in humans. The study will measure the effect of once daily dosing of XL184 on the pharmacokinetics (PK) of rosiglitazone. The PK of XL184 when combined with rosiglitazone will be evaluated as well. A specific objective of this study is to determine whether the interaction between XL184 and a drug such as rosiglitazone is sufficiently large enough to necessitate a dosage adjustment when used in combination with XL184, or whether the interaction would require additional therapeutic monitoring. Rosiglitazone, commonly known as Avandia, is a prescription medicine approved by the FDA used to treat adults with Type 2 (adult-onset or non-insulin dependent) diabetes mellitus (high blood sugar). In this study, subjects will only take 2 doses of rosiglitazone. There is no intention of therapy as a result of taking rosiglitazone in this study.
Interventions
- DRUG rosiglitazone
- DRUG XL184
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2010-04 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01100619
The ClinicalTrials.gov registry entry for NCT01100619 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Exelixis, which has 48 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which rosiglitazone is the first listed.
NCT01100619 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01100619 about?
NCT01100619 is a clinical study titled "A Drug-Drug Interaction Study of the Effects of XL184 (Cabozantinib) on Rosiglitazone in Subjects With Solid Tumors". The primary objective of this clinical study is to determine whether the inhibition of cytochrome P450 (CYP) isozyme CYP2C8 by XL184 observed in in vitro preclinical studies translates into the potential for clinically significant drug-drug interactions in humans. The study will measure the effect o...
What is the current status of trial NCT01100619?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 40 participants. The study started on 2010-04.
What interventions are being tested in trial NCT01100619?
The interventions under investigation include: rosiglitazone (DRUG), XL184 (DRUG).
Who is sponsoring clinical trial NCT01100619?
This trial is sponsored by Exelixis, which has 48 total clinical trials registered on ClinicalTrials.gov.
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