- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00596648
A Study of XL184 (Cabozantinib) With or Without Erlotinib in Adults With Non-Small Cell Lung Cancer
September 17, 2013 updated by: Exelixis
A Phase 1b/2 Study of XL184 With or Without Erlotinib in Subjects With Non-Small Cell Lung Cancer
In Phase 1 of this study, the purpose is to evaluate the safety, tolerability, and highest safe dose of the multiple receptor tyrosine kinase inhibitor (including VEGFR2, MET, and RET) XL184 in combination with the EGFR inhibitor erlotinib administered to adults with Non-Small-Cell Lung Cancer (NSCLC).
In Phase 2 of this study, the purpose is to evaluate the objective response rate of daily oral administration of XL184 with or without erlotinib in subjects with NSCLC who have progressed after responding to treatment with erlotinib.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
92
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Alaska
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Anchorage, Alaska, United States, 99508
- Katmai Oncology Group
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California
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Palo Alto, California, United States, 94305
- Stanford University Medical Center
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Sacramento, California, United States, 95817
- University of California, Davis
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Connecticut
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New Haven, Connecticut, United States, 06520
- Yale University School of Medicine
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District of Columbia
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Washington, District of Columbia, United States, 20007
- Georgetown University/Lombardi Comprehensive Cancer Center
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Illinois
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Chicago, Illinois, United States, 60637
- University of Chicago Medical Center
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Massachusetts
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Boston, Massachusetts, United States, 02115
- Dana Farber Cancer Institute
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Minnesota
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St. Louis Park, Minnesota, United States, 55416
- Park Nicollet Institute
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New Jersey
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Berkeley Heights, New Jersey, United States, 07922
- Summit Medical Group
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Ohio
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Cleveland, Ohio, United States, 44106
- Case Western Reserve University
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Texas
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Houston, Texas, United States, 77030
- MD Anderson Cancer Center
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Washington
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Seattle, Washington, United States, 98104
- Swedish Cancer Institute
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Seattle, Washington, United States, 98109
- University of Washington/ Seattle Cancer Care Alliance
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Histologically confirmed NSCLC and Stage 3b or 4 NSCLC (Phase 1 only), Stage 3b or 4 NSCLC (Phase 2 only)
- Documented progressive disease following a prior RECIST response to monotherapy with erlotinib OR documented progressive disease following stable disease of at least 6 months on monotherapy with erlotinib (Phase 2 only)
- Must have tolerated erlotinib at the maximal dose that will be administered in Phase 2 only (or at a higher dose) for a minimum of 6 weeks
- Measurable disease per RECIST (Phase 2 only)
- At least 18 years old
- ECOG performance status of 0 or 1
- Adequate organ and marrow function
- Sexually active subjects must agree to use medically accepted methods of contraception during the course of the study and for 3 months following discontinuation of study treatment (excluding women who are not of child bearing potential and men who have been sterilized).
- Female subjects of childbearing potential must have a negative pregnancy test at enrollment
- No other diagnosis of malignancy (unless non-melanoma skin cancer, carcinoma in situ of the cervix or malignancy diagnosed ≥ 2 years previously, and currently with no evidence of disease).
- Capable of understanding and complying with the protocol, and written informed consent
Exclusion Criteria:
- Received anti-cancer treatment within 4 weeks, except erlotinib, prior to first dose (Phase 1 only)
In Phase 2 only: the subject has received:
- Small molecule inhibitors of VEGFR2/KDR OR
- An investigational anti-cancer agent within 4 weeks of the first dose of study drug OR
- An investigational agent that targets EGF or EGFR at any time OR
- An approved agent that targets EGF or EGFR (with the exception of erlotinib and gefitinib) at any time unless approved by Exelixis OR
- Anti-cancer therapy within 4 weeks (with the exception of gefitinib and erlotinib) of the first dose of study drug OR
- Prior therapy with a c-Met inhibitor
- Not recovered to NCI CTCAE v.3 Grade ≤1 from clinically significant adverse events due to antineoplastic agents, investigational drugs, or other medications administered prior to study enrollment
- Symptomatic or uncontrolled brain metastases requiring current treatment, including steroids and anticonvulsants
- History of significant hematemesis or recent history of hemoptysis
- Presence of cavitation, central lesion, or lesion abutting a major blood vessel
- Intercurrent illness such as hypertension or cardiac arrhythmias or recent history of significant disease such as congestive heart failure
- Pregnant or breastfeeding
- Active bacterial or viral infection requiring systemic treatment
- Allergy or hypersensitivity to components of either the XL184 or erlotinib formulations
- Incapable of understanding and complying with the protocol or unable to provide informed consent
- History of idiopathic pulmonary fibrosis or interstitial lung disease
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Phase 1 Arm
Escalating doses of XL184 + erlotinib
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Capsules administered orally daily
Tablets administered orally daily.
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Experimental: Phase 2 Arm 1
XL184 + erlotinib (dose determined from Phase 1 portion of study)
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Capsules administered orally daily
Tablets administered orally daily.
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Experimental: Phase 2 Arm 2
XL184 administered as a single agent
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Capsules administered orally daily
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
In Phase 1 of the study: evaluate safety, tolerability, and maximum tolerated dose of daily oral administration of XL184 in combination with erlotinib to subjects with NSCLC
Time Frame: Assessed at each visit
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Assessed at each visit
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In Phase 1 of the study, to evaluate pharmacodynamic effects of XL184 administration in combination with erlotinib
Time Frame: Assessed at periodic visits
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Assessed at periodic visits
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In Phase 1 of the study, to characterize pharmacokinetic parameters of single agent erlotinib, and of XL184 in combination with erlotinib
Time Frame: Assessed at periodic visits (approx. every 8 weeks)
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Assessed at periodic visits (approx. every 8 weeks)
|
In Phase 2 of the study, to estimate the objective response rate of XL184 with or without erlotinib in adults with NSCLC who have progressed after responding to erlotinib
Time Frame: Assessed approx. every 8 weeks
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Assessed approx. every 8 weeks
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In Phase 2 of the study, to assess pharmacodynamic effects of XL184 administration either alone or with erlotinib
Time Frame: Assessed at periodic visits
|
Assessed at periodic visits
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
In Phase 1 and 2 of the study, to evaluate the long-term safety and tolerability of XL184 administered either alone or in combination with erlotinib
Time Frame: Assessed at periodic visits
|
Assessed at periodic visits
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In Phase 2 of the study, to assess progression-free survival, duration of response, and overall survival following treatment with XL184 either alone or in combination with erlotinib
Time Frame: Assessed at periodic visits (approx. every 8 weeks)
|
Assessed at periodic visits (approx. every 8 weeks)
|
In Phase 2 of the study, to characterize pharmacokinetic parameters of XL184 as a single agent and XL184 in combination with erlotinib in subjects with NSCLC
Time Frame: Assessed at periodic visits (every 8 weeks)
|
Assessed at periodic visits (every 8 weeks)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2007
Primary Completion (Actual)
August 1, 2012
Study Registration Dates
First Submitted
January 8, 2008
First Submitted That Met QC Criteria
January 8, 2008
First Posted (Estimate)
January 17, 2008
Study Record Updates
Last Update Posted (Estimate)
September 19, 2013
Last Update Submitted That Met QC Criteria
September 17, 2013
Last Verified
September 1, 2013
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Neoplasms
- Lung Diseases
- Neoplasms by Site
- Respiratory Tract Neoplasms
- Thoracic Neoplasms
- Carcinoma, Bronchogenic
- Bronchial Neoplasms
- Lung Neoplasms
- Carcinoma, Non-Small-Cell Lung
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antineoplastic Agents
- Protein Kinase Inhibitors
- Erlotinib Hydrochloride
Other Study ID Numbers
- XL184-202
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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