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
Heather Wakelee

Winston Chen and Phyllis Huang Professor

A. Dimitrios Colevas, MD
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.
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

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