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

Trial ID or NCT#

NCT00522145

Status

not recruiting iconNOT RECRUITING

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.

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

Eligibility Criteria

Ages Eligible for Study: Older than 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. * Histologically confirmed diagnosis of unresectable Stage IIIB or Stage IV relapsed or recurrent NSCLC.* Subjects must have:
    1. 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:
  1. * 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.
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Investigator(s)

Heather Wakelee
Heather Wakelee
Medical oncologist, Thoracic specialist
Winston Chen and Phyllis Huang Professor
A. Dimitrios Colevas, MD
A. Dimitrios Colevas, MD
Medical oncologist, Head and neck specialist, Cutaneous oncology specialist
Professor of Medicine (Oncology) and, by courtesy, of Otolaryngology - Head & Neck Surgery (OHNS) and of Radiation Oncology (Radiation Therapy)
George A. Fisher Jr.
George A. Fisher Jr.
Medical oncologist, Gastrointestinal specialist
Colleen Haas Chair in the School of Medicine

Contact us to find out if this trial is right for you.

Contact

Lisa Zhou
6507364112

View on ClinicalTrials.gov