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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

Phase 2
18 Years
Not Enrolling
Carcinoma, Non-Small-Cell Lung

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Trial Information

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

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

Exclusion Criteria:

- Received radiation to ≥25% of his or her bone marrow within 30 days of XL647

- 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

- 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.

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Determine the best confirmed response rate

Outcome Time Frame:

Inclusion until disease progression

Safety Issue:



United States: Food and Drug Administration

Study ID:




Start Date:

May 2007

Completion Date:

February 2010

Related Keywords:

  • Carcinoma, Non-Small-Cell Lung
  • Non-Small-Cell Lung Cancer
  • Carcinoma
  • Carcinoma, Non-Small-Cell Lung



Memorial Sloan-Kettering Cancer Center New York, New York  10021
University of California Davis Cancer Center Sacramento, California  95817
Case Western Reserve University, University Hospitals of Cleveland Cleveland, Ohio  44106
Washington County Hospital, The Center for Clinical Research Hagerstown, Maryland  21742
Ronald Yanagihara Gilroy, California  95020
Oncology Division and General Clincial Research, Stanford University Medical Center Stanford, California  94305
Cancer Care Center, Inc. P.C. New Albany, Indiana  47150
Wayne State University, Wertz Clinical Cancer Center, Karmanos Center Detroit, Michigan  48201
New Bern Cancer Care Oncology New Bern, North Carolina  28560
Signal Point Clinical Research Center Middletown, Ohio  45042