Status:
COMPLETED
Study of XL647 in Subjects With Non-Small-Cell Lung Cancer
Lead Sponsor:
Kadmon Corporation, LLC
Conditions:
Non-small-cell Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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 t...
Eligibility Criteria
Inclusion
- 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
- 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 enrollment
- 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 dysfunction
- 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 range
- The subject has progressive symptomatic or hemorrhagic brain or leptomeningeal metastases
- Uncontrolled intercurrent illness
- Subject is pregnant or breastfeeding
- Known HIV
Key Trial Info
Start Date :
July 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2010
Estimated Enrollment :
55 Patients enrolled
Trial Details
Trial ID
NCT00364780
Start Date
July 1 2006
End Date
August 1 2010
Last Update
May 13 2022
Active Locations (7)
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1
Hematology Oncology Associates of the Treasure Coast
Port Saint Lucie, Florida, United States, 34952
2
University of Chicago
Chicago, Illinois, United States, 60637
3
Carle Cancer Center
Urbana, Illinois, United States, 61801
4
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114