Study of XL647 in Subjects With Non-Small-Cell Lung Cancer
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).
Ask AI to explain this studyKey things to know
This describes the study’s primary purpose.
The study team can explain what participation involves.
These are broad labels—not an eligibility decision.
Checked against the public recordLast updated May 13, 2022 · Source: ClinicalTrials.gov
Ask the study team to confirm whether enrollment is open.
Interventional
Locations may change over time.
Study sponsor
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 2
- Sponsor
- Kadmon Corporation, LLC
- Interventions being studied
- Drug: XL647
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.
- 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
- 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
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- Hematology Oncology Associates of the Treasure CoastPort Saint Lucie, Florida
- University of ChicagoChicago, Illinois
- Carle Cancer CenterUrbana, Illinois
- Massachusetts General HospitalBoston, Massachusetts
- Wayne University, Wertz Clinical Cancer Center, Karmanos CenterDetroit, Michigan
- Memorial Sloan Kettering Cancer CenterNew York, New York
- Case Western Reserve University, University Hospitals of ClevelandCleveland, Ohio
Source and freshness
Processed from ClinicalTrials.gov. Last public update: May 13, 2022. Always confirm current availability with the study team.