A Drug-Drug Interaction Study of the Effects of XL184 on Rosiglitazone in Subjects With Solid Tumors



Status:Archived
Conditions:Cancer, Cancer, Thyroid Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:Any
Updated:7/1/2011
Start Date:April 2010

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A Phase 1 Drug-Drug Interaction Study of the Effects of XL184 on the Pharmacokinetics of a Single Oral Dose of 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 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.



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3400 Spruce St
Philadelphia, Pennsylvania 19104
 (215) 662-4000
Hospital of the University of Pennsylvania The Hospital of the University of Pennsylvania (HUP) is...
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3550 Jerome Avenue
Bronx, New York 10467
(718) 920-4321
Montefiore Medical Center As the academic medical center and University Hospital for Albert Einstein College...
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Bronx, NY
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1500 E Duarte Rd
Duarte, California 91010
(626) 256-4673
City of Hope Comprehensive Cancer Center City of Hope is a leading research and treatment...
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Duarte, CA
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450 Brookline Ave
Boston, Massachusetts 2215
617-632-3000
Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
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Boston, MA
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1515 Holcombe Blvd
Houston, Texas 77030
 713-792-2121
University of Texas M.D. Anderson Cancer Center The mission of The University of Texas MD...
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Houston, TX
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