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

Sponsor:	Kadmon Corporation, LLC
Information provided by (Responsible Party):	Kadmon Corporation, LLC
ClinicalTrials.gov Identifier:	NCT00522145

Purpose

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.

Condition	Intervention	Phase
Carcinoma, Non-Small-Cell Lung	Drug: XL647	Phase II

Study Type:	Interventional
Study Design:	Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer

Drug Information available for: Erlotinib hydrochloride Erlotinib ZD1839 XL 647

U.S. FDA Resources

Further study details as provided by Kadmon Corporation, LLC:

Primary Outcome Measures:

Determine the best confirmed response rate [ Time Frame: Inclusion until disease progression ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Safety and tolerability of XL647 administered daily [ Time Frame: First treatment until 30 day post last treatment ] [ Designated as safety issue: Yes ]
Progression-free survival, duration of response, and overall survival [ Time Frame: Incusion until disease progression ] [ Designated as safety issue: No ]
Further characterize the pharmacokinetic (PK) parameters [ Time Frame: Every 8 weeks after Day 57 until disease progression ] [ Designated as safety issue: No ]

Enrollment:	41
Study Start Date:	May 2007
Study Completion Date:	February 2010
Primary Completion Date:	October 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Group 1	Drug: XL647 Daily dosing as a single oral agent at a dose of 300 mg supplied as 50-mg tablets Other Name: KD019

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Histologically confirmed diagnosis of unresectable Stage IIIB or Stage IV relapsed or recurrent NSCLC.
Subjects must have:
1. 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
2. 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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00522145

Locations

United States, California
Ronald Yanagihara
Gilroy, California, United States, 95020
University of California Davis Cancer Center
Sacramento, California, United States, 95817
Oncology Division and General Clincial Research, Stanford University Medical Center
Stanford, California, United States, 94305
United States, Indiana
Cancer Care Center, Inc. P.C.
New Albany, Indiana, United States, 47150
United States, Maryland
Washington County Hospital, The Center for Clinical Research
Hagerstown, Maryland, United States, 21740
United States, Michigan
Wayne State University, Wertz Clinical Cancer Center, Karmanos Center
Detroit, Michigan, United States, 48201
United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
United States, North Carolina
New Bern Cancer Care Oncology
New Bern, North Carolina, United States, 28560
United States, Ohio
Case Western Reserve University, University Hospitals of Cleveland
Cleveland, Ohio, United States, 44106
Signal Point Clinical Research Center
Middletown, Ohio, United States, 45042

Sponsors and Collaborators

Kadmon Corporation, LLC

More Information

No publications provided

Responsible Party:	Kadmon Corporation, LLC
ClinicalTrials.gov Identifier:	NCT00522145 History of Changes
Other Study ID Numbers:	XL647-203
Study First Received:	August 27, 2007
Last Updated:	January 24, 2012
Health Authority:	United States: Food and Drug Administration

Keywords provided by Kadmon Corporation, LLC:

Non-Small-Cell Lung Cancer

Additional relevant MeSH terms:

Carcinoma
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site

Lung Diseases
Respiratory Tract Diseases
Gefitinib
Erlotinib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on February 12, 2012