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A Phase 2 Study of XL647 in Subjects With Non-Small-Cell Lung Cancer

Phase 2
18 Years
Not Enrolling
Non-small-cell Lung Cancer

Thank you

Trial Information

A Phase 2 Study of XL647 in Subjects With Non-Small-Cell Lung Cancer

Inclusion Criteria:

- Subject has NSCLC with a histologically confirmed diagnosis of adenocarcinoma with
measurable disease (stage IIIB, with malignant pleural effusion, and stage IV) and
either has a demonstrated activating mutation of the EGF receptor in tumor tissue or
meets one of three criteria: asian, female, and minimal or no smoking history.

- Measurable disease defined according to RECIST

- ECOG performance status of 0 or 1

- Normal organ and marrow function

- No other malignancies within 5 years, except for non-melanoma skin cancer

Exclusion Criteria:

- Radiation to ≥25% of bone marrow within 30 days of XL647 treatment

- Prior systemic anticancer therapy, including cytotoxic chemotherapy, anti-VEGF,
anti-VEGFR, or anti-EGFR agents or investigational drug

- Subject has not recovered to ≤ grade 1 or to within 10% of baseline values from
adverse events due to other medications administered > 30 days before study

- Receiving anticoagulation therapy with warfarin (low-dose warfarin < 1 mg/day,
heparin and low molecular weight heparins are permitted)

- The subject meets any of the following cardiac criteria:

- Corrected QT interval (QTc) of > 460 msec

- Family history of congenital long QT syndrome or unexplained sudden death

- History of sustained ventricular arrhythmias

- Has a finding of left bundle branch block

- Has an obligate pacemaker

- Has important bradycardia defined as a heart rate of < 50 bpm due to sinus node

- Has uncontrolled hypertension

- Has symptomatic congestive heart failure, unstable angina, or a myocardial
infarction within the past 3 months

- Has a serum potassium or serum magnesium level that falls outside the normal

- The subject has progressive symptomatic or hemorrhagic brain or leptomeningeal

- Uncontrolled intercurrent illness

- Subject is pregnant or breastfeeding

- Known HIV

Type of Study:


Study Design:

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

Outcome Measure:

Response rate

Outcome Time Frame:

Inclusion until disease progression

Safety Issue:



United States: Food and Drug Administration

Study ID:




Start Date:

July 2006

Completion Date:

August 2010

Related Keywords:

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



Memorial Sloan Kettering Cancer Center New York, New York  10021
Massachusetts General Hospital Boston, Massachusetts  02114-2617
Carle Cancer Center Urbana, Illinois  61801
University of Chicago Chicago, Illinois  60637
Hematology Oncology Associates of the Treasure Coast Port St. Lucie, Florida  34952
Wayne University, Wertz Clinical Cancer Center, Karmanos Center Detroit, Michigan  48201
Case Western Reserve University, University Hospitals of Cleveland Cleveland, Ohio  44106