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Study of XL647 Administered Orally Daily to Patients With Solid Tumors

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00336765
First Posted: June 14, 2006
Last Update Posted: October 18, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Kadmon Corporation, LLC
June 12, 2006
June 14, 2006
October 18, 2011
July 2006
August 2010   (Final data collection date for primary outcome measure)
Evaluate safety, tolerability, and maximum tolerated dose of XL647 [ Time Frame: Inclusion until 30 days post last treatment ]
safety and tolerability
Complete list of historical versions of study NCT00336765 on ClinicalTrials.gov Archive Site
  • Characterize pharmacokinetics and pharmacodynamic effects of XL647 [ Time Frame: At various time points from pre-dosing until post dosing ]
  • Evaluate preliminary tumor response [ Time Frame: Inclusion until disease progression ]
  • pharmacokinetics
  • pharmacodynamic effects
  • tumor response
Not Provided
Not Provided
 
Study of XL647 Administered Orally Daily to Patients With Solid Tumors
A Phase 1 Dose-Escalation Study of the Safety and Pharmacokinetics of XL647 Administered Orally Daily to Subjects With Solid Tumors
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.
Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Cancer
Drug: XL647
Tablets supplied in 50-mg strength administered orally daily
Other Name: KD019
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
31
September 2010
August 2010   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00336765
XL647-002
Yes
Not Provided
Not Provided
Kadmon Corporation, LLC
Kadmon Corporation, LLC
Not Provided
Not Provided
Kadmon Corporation, LLC
October 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP