Clincosm LogoSign in Get a demo

Study of XL647 in Subjects With NSCLC Who Have Progressed After Responding to Treatment With Gefitinib or Erlotinib

Sponsor
Kadmon Corporation, LLC (Industry)
Overall Status
Completed
CT.gov ID
NCT00522145
Collaborator
(none)
41
Enrollment
10
Locations
1
Arm
33.1
Duration (Months)
4.1
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
41 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase 2 Study of XL647 in Subjects With Non-Small Cell Lung Cancer Who Have Progressed After Responding to Treatment With Either Gefitinib or Erlotinib
Study Start Date :
May 1, 2007
Actual Primary Completion Date :
Oct 1, 2009
Actual Study Completion Date :
Feb 1, 2010

Arms and Interventions

Arm Intervention/Treatment
Experimental: Group 1

Drug: XL647
Daily dosing as a single oral agent at a dose of 300 mg supplied as 50-mg tablets
Other Names:
  • KD019

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Determine the best confirmed response rate [Inclusion until disease progression]

    Secondary Outcome Measures

    1. Safety and tolerability of XL647 administered daily [First treatment until 30 day post last treatment]

    2. Progression-free survival, duration of response, and overall survival [Incusion until disease progression]

    3. Further characterize the pharmacokinetic (PK) parameters [Every 8 weeks after Day 57 until disease progression]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • 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.

    Exclusion Criteria:

    • 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Ronald Yanagihara Gilroy California United States 95020
    2 University of California Davis Cancer Center Sacramento California United States 95817
    3 Oncology Division and General Clincial Research, Stanford University Medical Center Stanford California United States 94305
    4 Cancer Care Center, Inc. P.C. New Albany Indiana United States 47150
    5 Washington County Hospital, The Center for Clinical Research Hagerstown Maryland United States 21740
    6 Wayne State University, Wertz Clinical Cancer Center, Karmanos Center Detroit Michigan United States 48201
    7 Memorial Sloan-Kettering Cancer Center New York New York United States 10021
    8 New Bern Cancer Care Oncology New Bern North Carolina United States 28560
    9 Case Western Reserve University, University Hospitals of Cleveland Cleveland Ohio United States 44106
    10 Signal Point Clinical Research Center Middletown Ohio United States 45042

    Sponsors and Collaborators

    • Kadmon Corporation, LLC

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Kadmon Corporation, LLC
    ClinicalTrials.gov Identifier:
    NCT00522145
    Other Study ID Numbers:
    • XL647-203
    First Posted:
    Aug 29, 2007
    Last Update Posted:
    May 13, 2022
    Last Verified:
    May 1, 2022
    Keywords provided by Kadmon Corporation, LLC
    Non-Small-Cell Lung Cancer
    Additional relevant MeSH terms:
    Carcinoma, Non-Small-Cell Lung
    XL647

    Study Results

    No Results Posted as of May 13, 2022