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Study of XL647 in Subjects With NSCLC Who Have Progressed After Responding to Treatment With Gefitinib or Erlotinib
This study is ongoing, but not recruiting participants.
First Received: August 27, 2007   Last Updated: July 30, 2009   History of Changes
Sponsor: Symphony Evolution, Inc.
Information provided by: Symphony Evolution, Inc.
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: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
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:


Further study details as provided by Symphony Evolution, Inc.:

Primary Outcome Measures:
  • Determine the best confirmed response rate

Secondary Outcome Measures:
  • Safety and tolerability of XL647 administered daily
  • Progression-free survival, duration of response, and overall survival
  • Further characterize the pharmacokinetic (PK) parameters

Estimated Enrollment: 34
Study Start Date: May 2007
  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
Gilroy, California, United States, 95020
Stanford, California, United States, 94305
United States, Florida
Vero Beach, Florida, United States, 32960
United States, Indiana
New Albany, Indiana, United States, 47150
United States, Maryland
Hagerstown, Maryland, United States, 21740
United States, Michigan
Detroit, Michigan, United States, 48201
United States, New York
New York, New York, United States, 10021
United States, North Carolina
New Bern, North Carolina, United States, 28560
United States, Ohio
Middletown, Ohio, United States, 45042
United States, Texas
Corpus Christi, Texas, United States, 78405
Sponsors and Collaborators
Symphony Evolution, Inc.
  More Information

No publications provided

Responsible Party: Symphony Evolution, Inc. ( Charles W. Finn, PhD, President and CEO )
Study ID Numbers: XL647-203
Study First Received: August 27, 2007
Last Updated: July 30, 2009
ClinicalTrials.gov Identifier: NCT00522145     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by Symphony Evolution, Inc.:
Non-Small-Cell Lung Cancer

Additional relevant MeSH terms:
Thoracic Neoplasms
Respiratory Tract Neoplasms
Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type
Respiratory Tract Diseases
Lung Neoplasms
Lung Diseases
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial
Carcinoma

ClinicalTrials.gov processed this record on November 25, 2009