Study of XL647 in Subjects With NSCLC Who Have Progressed After Responding to Treatment With Gefitinib or Erlotinib
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
1 other identifier
interventional
41
1 country
10
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started May 2007
Typical duration for phase_2
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2007
CompletedFirst Submitted
Initial submission to the registry
August 27, 2007
CompletedFirst Posted
Study publicly available on registry
August 29, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2010
CompletedMay 13, 2022
May 1, 2022
2.4 years
August 27, 2007
May 9, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Determine the best confirmed response rate
Inclusion until disease progression
Secondary Outcomes (3)
Safety and tolerability of XL647 administered daily
First treatment until 30 day post last treatment
Progression-free survival, duration of response, and overall survival
Incusion until disease progression
Further characterize the pharmacokinetic (PK) parameters
Every 8 weeks after Day 57 until disease progression
Study Arms (1)
Group 1
EXPERIMENTALInterventions
Daily dosing as a single oral agent at a dose of 300 mg supplied as 50-mg tablets
Eligibility Criteria
You may qualify if:
- Histologically confirmed diagnosis of unresectable Stage IIIB or Stage IV relapsed or recurrent NSCLC.
- Subjects must have:
- 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
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (10)
Ronald Yanagihara
Gilroy, California, 95020, United States
University of California Davis Cancer Center
Sacramento, California, 95817, United States
Oncology Division and General Clincial Research, Stanford University Medical Center
Stanford, California, 94305, United States
Cancer Care Center, Inc. P.C.
New Albany, Indiana, 47150, United States
Washington County Hospital, The Center for Clinical Research
Hagerstown, Maryland, 21740, United States
Wayne State University, Wertz Clinical Cancer Center, Karmanos Center
Detroit, Michigan, 48201, United States
Memorial Sloan-Kettering Cancer Center
New York, New York, 10021, United States
New Bern Cancer Care Oncology
New Bern, North Carolina, 28560, United States
Case Western Reserve University, University Hospitals of Cleveland
Cleveland, Ohio, 44106, United States
Signal Point Clinical Research Center
Middletown, Ohio, 45042, United States
Related Publications (1)
Pietanza MC, Lynch TJ Jr, Lara PN Jr, Cho J, Yanagihara RH, Vrindavanam N, Chowhan NM, Gadgeel SM, Pennell NA, Funke R, Mitchell B, Wakelee HA, Miller VA. XL647--a multitargeted tyrosine kinase inhibitor: results of a phase II study in subjects with non-small cell lung cancer who have progressed after responding to treatment with either gefitinib or erlotinib. J Thorac Oncol. 2012 Jan;7(1):219-26. doi: 10.1097/JTO.0b013e31822eebf9.
PMID: 22011666BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 27, 2007
First Posted
August 29, 2007
Study Start
May 1, 2007
Primary Completion
October 1, 2009
Study Completion
February 1, 2010
Last Updated
May 13, 2022
Record last verified: 2022-05