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

Completed · Phase 2

Conditions studied: Non-small-cell Lung Cancer

In brief

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).

Key facts

Study ID

NCT00364780

Run by

Kadmon Corporation, LLC

People needed

55

Starts

2006-07-01

Expected to finish

2010-08-01

Last updated by the study team

2022-05-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• 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
• 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

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.