Clinical Trial: A Drug-Drug Interaction Study of the Effects of XL184 (Cabozantinib) on Rosiglitazone in Subjects With Solid Tumors

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

Brief 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.


Detailed Summary:
Sponsor: Exelixis

Current Primary Outcome: Pharmacokinetics of XL184 and rosiglitazone [ Time Frame: at weekly or twice-weekly visits for the first 4 weeks ]

To evaluate the effect of multiple daily doses of XL184 on single dose PK of rosiglitazone


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Safety and tolerability of repeated administration of XL184 [ Time Frame: at weekly or twice-weekly visits, then every 4 weeks ]
    To evaluate safety and tolerability of daily oral administration of XL184 and two single doses of rosiglitazone
  • Pharmacokinetics of XL184 after co-administration of rosiglitazone [ Time Frame: at weekly or twice-weekly visits for 4 weeks ]
    To evaluate the plasma PK of XL184 after a single dose of rosiglitazone


Original Secondary Outcome: Same as current

Information By: Exelixis

Dates:
Date Received: March 22, 2010
Date Started: April 2010
Date Completion:
Last Updated: September 17, 2013
Last Verified: September 2013