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Study of XL647 in Subjects With NSCLC Who Have Progressed After Responding to Treatment With Gefitinib or Erlotinib
Not Recruiting
Trial ID: 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.
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
Stanford Investigator(s)
Heather Wakelee
Professor of Medicine (Oncology)
A. Dimitrios Colevas, MD
Professor of Medicine (Oncology) and, by courtesy, of Otolaryngology - Head & Neck Surgery (OHNS) and of Radiation Oncology (Radiation Therapy)
George A. Fisher Jr.
Colleen Haas Chair in the School of Medicine
Eligibility
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.
Intervention(s):
drug: XL647
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Lisa Zhou
6507364112