Study of XL647 in Subjects With NSCLC Who Have Progressed After Responding to Treatment With Gefitinib or Erlotinib
The purpose of this study is to determine the best confirmed response rate of daily administration of the multiple receptor tyrosine kinase (RTK) inhibitor (including EGFR and VEGFR2) XL647 in subjects with NSCLC who have progressed after responding to treatment with either erlotinib or gefitinib.
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
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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.
- Histologically confirmed diagnosis of unresectable Stage IIIB or Stage IV relapsed or recurrent NSCLC.
- Subjects must have: 1. documented (radiological or clinical) progressive disease (PD) following a prior response (including stable disease) to monotherapy with erlotinib or gefitinib that was administered for at least 12 weeks prior to progression OR 2. a documented T790M EGFR mutation
- Measurable disease defined according to RECIST
- ECOG performance status of 0 or 1.
- Sexually active subjects must use an accepted method of contraception during the course of the study.
- Female subjects of childbearing potential must have a negative pregnancy test at enrollment.
- Received radiation to ≥25% of his or her bone marrow within 30 days of XL647 treatment.
- Received erlotinib or gefitinib, or other anticancer therapy within 14 days of the first dose of study drug.
- Received an investigational drug (excluding erlotinib or gefitinib) within 30 days of the first dose of study drug.
- Receiving anticoagulation therapy with warfarin.
- Not recovered to Grade ≤1 from adverse events (AEs) due to antineoplastic agents, investigational drugs, or other medications that were administered prior to study enrollment.
- Corrected QT interval (QTc) of \>0.45 seconds.
- Progressive, symptomatic, or hemorrhagic brain or leptomeningeal metastases.
- Requires steroid or anticonvulsant therapy for the treatment of brain metastases.
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- Ronald YanagiharaGilroy, California
- University of California Davis Cancer CenterSacramento, California
- Oncology Division and General Clincial Research, Stanford University Medical CenterStanford, California
- Cancer Care Center, Inc. P.C.New Albany, Indiana
- Washington County Hospital, The Center for Clinical ResearchHagerstown, Maryland
- Wayne State University, Wertz Clinical Cancer Center, Karmanos CenterDetroit, Michigan
- Memorial Sloan-Kettering Cancer CenterNew York, New York
- New Bern Cancer Care OncologyNew Bern, North Carolina
- Case Western Reserve University, University Hospitals of ClevelandCleveland, Ohio
- Signal Point Clinical Research CenterMiddletown, Ohio
Source and freshness
Processed from ClinicalTrials.gov. Last public update: May 13, 2022. Always confirm current availability with the study team.