The purpose of this phase II study is to determine the safety, tolerability, and activity of XL647 in previously untreated subjects with non-small cell lung cancer (NSCLC). XL647 is a small molecule that potently inhibits multiple receptor kinases, including EGFR, VEGFR2 (KDR), ErbB2, and EphB4. Sensitivity to EGFR inhibitors has been linked to specific EGFR mutations and associated with certain clinical characteristics in patients with NSCLC (eg, female, minimal and remote smoking history, and adenocarcinoma histology).
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
55
XL647 will be administered orally as a single agent. XL647 will be supplied as 50 mg tablets. Subjects in the Intermittent 5 \& 9 cohort will receive XL647 at a dose of 350 mg on a 5 days on and 9 days off cycle every 2 weeks for 8 weeks. Subjects in the Daily Dosing cohort will receive XL647 administered daily as a single oral dose of 300 mg. In the absence of progressive disease (PD) and unacceptable XL647-related toxicity, subjects may continue to receive XL647 treatment on their assigned dosing schedule for up to 1 year on this study. Subjects who reach 1 year of treatment with no evidence of disease progression may, with the concurrence of the investigator and the sponsor, continue to receive therapy.
Hematology Oncology Associates of the Treasure Coast
Port Saint Lucie, Florida, United States
University of Chicago
Chicago, Illinois, United States
Carle Cancer Center
Urbana, Illinois, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Response rate
Time frame: Inclusion until disease progression
Safety and tolerability
Time frame: Inclusion until 30 days post last treatment
Progression-free survival
Time frame: Inclusion until disease progression or death
Duration of response
Time frame: Inclusion until disease progression
Overall survival
Time frame: Inclusion until 180-Day Follow-up post last treatment
Pharmacokinetic and pharmacodynamic parameters
Time frame: At various time points from pre-dosing until post dosing
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Wayne University, Wertz Clinical Cancer Center, Karmanos Center
Detroit, Michigan, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Case Western Reserve University, University Hospitals of Cleveland
Cleveland, Ohio, United States