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| Sponsor: | Exelixis |
|---|---|
| Information provided by: | Exelixis |
| ClinicalTrials.gov Identifier: | NCT01100619 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Papillary Thyroid Cancer Follicular Thyroid Cancer Huerthle Cell Thyroid Cancer Renal Cell Carcinoma |
Drug: rosiglitazone Drug: XL184 |
Phase I |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Pharmacokinetics Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | 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 |
| Estimated Enrollment: | 35 |
| Study Start Date: | April 2010 |
| Estimated Primary Completion Date: | December 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: All subjects
All subjects will receive daily XL184, and two single doses of rosiglitazone, 3 weeks apart
|
Drug: rosiglitazone
one 4 mg dose as a tablet followed by a second 4 mg dose 3 weeks later
Other Name: Avandia
Drug: XL184
dosed with capsules daily
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, California | |
| City of Hope Comprehensive Cancer Center | |
| Duarte, California, United States, 91010 | |
| United States, Massachusetts | |
| Dana Farber Cancer Institute | |
| Boston, Massachusetts, United States, 02115 | |
| United States, New York | |
| Montefiore Medical Center | |
| Bronx, New York, United States, 10466 | |
| United States, Pennsylvania | |
| Hospital of the University of Pennsylvania | |
| Philadelphia, Pennsylvania, United States, 19104 | |
| United States, Texas | |
| The University of Texas M.D. Anderson Cancer Center | |
| Houston, Texas, United States, 77230 | |
More Information
| Responsible Party: | Jaymes Holland, Senior Director, Clinical Science, Exelixis, Inc. |
| ClinicalTrials.gov Identifier: | NCT01100619 History of Changes |
| Other Study ID Numbers: | XL184-008 |
| Study First Received: | March 22, 2010 |
| Last Updated: | June 2, 2011 |
| Health Authority: | United States: Food and Drug Administration |
|
Carcinoma Thyroid Neoplasms Carcinoma, Renal Cell Thyroid Diseases Adenocarcinoma, Follicular Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Endocrine Gland Neoplasms Neoplasms by Site Head and Neck Neoplasms |
Endocrine System Diseases Adenocarcinoma Kidney Neoplasms Urologic Neoplasms Urogenital Neoplasms Kidney Diseases Urologic Diseases Rosiglitazone Hypoglycemic Agents Physiological Effects of Drugs Pharmacologic Actions |