Study of XL647 in Subjects With NSCLC Who Have Progressed After Responding to Treatment With Gefitinib or Erlotinib - Tabular View

Tracking Information
First Received Date ^ICMJE	August 27, 2007
Last Updated Date	July 30, 2009
Start Date ^ICMJE	May 2007
Primary Completion Date
Current Primary Outcome Measures ^ICMJE (submitted: August 27, 2007)	Determine the best confirmed response rate
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00522145 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: August 27, 2007)	Safety and tolerability of XL647 administered daily Progression-free survival, duration of response, and overall survival Further characterize the pharmacokinetic (PK) parameters
Original Secondary Outcome Measures ^ICMJE	Same as current

Descriptive Information
Brief Title ^ICMJE	Study of XL647 in Subjects With NSCLC Who Have Progressed After Responding to Treatment With Gefitinib or Erlotinib
Official Title ^ICMJE	A Phase 2 Study of XL647 in Subjects With Non-Small Cell Lung Cancer Who Have Progressed After Responding to Treatment With Either Gefitinib or Erlotinib
Brief Summary	The purpose of this study is to determine the best confirmed response rate of daily administration of the multiple receptor tyrosine kinase (RTK) inhibitor (including EGFR and VEGFR2) XL647 in subjects with NSCLC who have progressed after responding to treatment with either erlotinib or gefitinib.
Detailed Description
Study Phase	Phase II
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Condition ^ICMJE	Carcinoma, Non-Small-Cell Lung
Intervention ^ICMJE	Drug: XL647
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	Active, not recruiting
Estimated Enrollment ^ICMJE	34
Completion Date
Primary Completion Date
Eligibility Criteria ^ICMJE	Inclusion Criteria: Histologically confirmed diagnosis of unresectable Stage IIIB or Stage IV relapsed or recurrent NSCLC. Subjects must have: documented (radiological or clinical) progressive disease (PD) following a prior response (including stable disease) to monotherapy with erlotinib or gefitinib that was administered for at least 12 weeks prior to progression OR a documented T790M EGFR mutation Measurable disease defined according to RECIST ECOG performance status of 0 or 1. Sexually active subjects must use an accepted method of contraception during the course of the study. Female subjects of childbearing potential must have a negative pregnancy test at enrollment. Exclusion Criteria: Received radiation to ≥25% of his or her bone marrow within 30 days of XL647 treatment. Received erlotinib or gefitinib, or other anticancer therapy within 14 days of the first dose of study drug. Received an investigational drug (excluding erlotinib or gefitinib) within 30 days of the first dose of study drug. Receiving anticoagulation therapy with warfarin. Not recovered to Grade ≤1 from adverse events (AEs) due to antineoplastic agents, investigational drugs, or other medications that were administered prior to study enrollment. Corrected QT interval (QTc) of >0.45 seconds. Progressive, symptomatic, or hemorrhagic brain or leptomeningeal metastases. Requires steroid or anticonvulsant therapy for the treatment of brain metastases.
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	NCT00522145
Responsible Party	Charles W. Finn, PhD, President and CEO, Symphony Evolution, Inc.
Study ID Numbers ^ICMJE	XL647-203
Study Sponsor ^ICMJE	Symphony Evolution, Inc.
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	Symphony Evolution, Inc.
Verification Date	July 2009
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP