Study of XL820 Given Orally Daily to Subjects With Solid Tumors - Tabular View

Tracking Information
First Received Date ^ICMJE	July 7, 2006
Last Updated Date	August 14, 2008
Start Date ^ICMJE	July 2006
Primary Completion Date
Current Primary Outcome Measures ^ICMJE (submitted: July 7, 2006)	maximum tolerated dose safety and tolerability
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00350831 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: July 7, 2006)	plasma pharmacokinetics pharmacodynamic effects long-term safety and tolerability
Original Secondary Outcome Measures ^ICMJE	Same as current

Descriptive Information
Brief Title ^ICMJE	Study of XL820 Given Orally Daily to Subjects With Solid Tumors
Official Title ^ICMJE	A Phase 1 Dose Escalation Study of the Safety and Pharmacokinetics of the KIT Inhibitor XL820 Administered Orally Daily to Subjects With Solid Tumors
Brief Summary	The purpose of this study is to assess the safety and tolerability of the KIT inhibitor XL820 when given orally daily to adults with advanced solid tumors.
Detailed Description
Study Phase	Phase I
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study
Condition ^ICMJE	Cancer
Intervention ^ICMJE	Drug: XL820
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Estimated Enrollment ^ICMJE	30
Completion Date
Primary Completion Date
Eligibility Criteria ^ICMJE	Inclusion Criteria: Subject has a histologically confirmed solid tumor that is metastatic or unresectable for which known effective measures do not exist or are no longer effective, and there are no known therapies to prolong survival Subject is at least 18 years old Subject has ECOG performance status ≤ 2 Subject has a life expectancy of > 3 months Subject has adequate organ and marrow function In the adrenocorticotropic hormone (ACTH) stimulation test, the subject has a serum cortisol level ≥ 20 ug/dL (552 nmol/L) 30-90 minutes after injection of ACTH Subject has given written informed consent Sexually active subjects (male and female) must use accepted methods of contraception during the course of the study. Female subjects of childbearing potential must have a negative pregnancy test at screening. Exclusion Criteria: Subject has received anticancer treatment within 30 days before the first dose of XL820, or has not recovered to grade ≤ 1 from adverse events due to agents administered more than 30 days earlier Subject has received radiation to ≥ 25% of his/her bone marrow within 30 days of XL820 treatment Subject has received an investigational agent within 30 days of the first dose of XL820 Subject has known brain metastases Subject has known uncontrolled intercurrent illness Subject is pregnant or lactating Subject is known to be positive for HIV Subject has a known allergy or hypersensitivity to any of the components of the XL820 formulation
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT ID ^ICMJE	NCT00350831
Responsible Party
Study ID Numbers ^ICMJE	XL820-002
Study Sponsor ^ICMJE	Exelixis
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	Exelixis
Verification Date	August 2008
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP