Study of XL647 Administered Orally Daily to Patients With Solid Tumors

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Kadmon Corporation, LLC

ClinicalTrials.gov Identifier:

NCT00336765

First received: June 12, 2006

Last updated: October 17, 2011

Last verified: October 2011

History of Changes

Tracking Information
First Received Date ^ICMJE	June 12, 2006
Last Updated Date	October 17, 2011
Start Date ^ICMJE	July 2006
Primary Completion Date	August 2010 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: February 15, 2010)	Evaluate safety, tolerability, and maximum tolerated dose of XL647 [ Time Frame: Inclusion until 30 days post last treatment ] [ Designated as safety issue: Yes ]
Original Primary Outcome Measures ^ICMJE (submitted: June 12, 2006)	safety and tolerability
Change History	Complete list of historical versions of study NCT00336765 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: February 15, 2010)	Characterize pharmacokinetics and pharmacodynamic effects of XL647 [ Time Frame: At various time points from pre-dosing until post dosing ] [ Designated as safety issue: No ] Evaluate preliminary tumor response [ Time Frame: Inclusion until disease progression ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ^ICMJE (submitted: June 12, 2006)	pharmacokinetics pharmacodynamic effects tumor response
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Study of XL647 Administered Orally Daily to Patients With Solid Tumors
Official Title ^ICMJE	A Phase 1 Dose-Escalation Study of the Safety and Pharmacokinetics of XL647 Administered Orally Daily to Subjects With Solid Tumors
Brief Summary	The purpose of this study is to assess the safety and tolerability of the multiple receptor tyrosine kinase (RTK) inhibitor (including EGFR, VEGFR2, ErbB2, and EphB4) XL647 when given orally daily to adults with advanced solid tumors.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 1
Study Design ^ICMJE	Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Cancer
Intervention ^ICMJE	Drug: XL647 Tablets supplied in 50-mg strength administered orally daily Other Name: KD019
Study Arm (s)	Not Provided
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	31
Completion Date	September 2010
Primary Completion Date	August 2010 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: Subject has histologically confirmed malignancy that is metastatic or unresectable Subject has disease that is assessable by tumor marker, physical, or radiologic means Subject is at least 18 years old Subject has an ECOG performance status ≤ 2 (Karnofsky ≥ 60%) Subject has a life expectancy ≥ 3 months Subject has normal organ and marrow function Subject gives written informed consent Subject must use an accepted method of contraception during the study Female subjects of childbearing potential must have a negative pregnancy test Exclusion Criteria: Subject has received anticancer treatment within 30 days of first dose of XL647 Subject has received another investigational agent within 30 days of first dose of XL647 Subject has known brain metastases Subject has corrected QT interval (QTc) of > 0.45 seconds Subject is currently receiving anticoagulation therapy with warfarin Subject has uncontrolled intercurrent illness Subject is pregnant or breastfeeding Subject has known HIV
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 Number ^ICMJE	NCT00336765
Other Study ID Numbers ^ICMJE	XL647-002
Has Data Monitoring Committee	Yes
Responsible Party	Kadmon Corporation, LLC
Study Sponsor ^ICMJE	Kadmon Corporation, LLC
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Kadmon Corporation, LLC
Verification Date	October 2011
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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