A Study of XL184 (Cabozantinib) With or Without Erlotinib in Adults With Non-Small Cell Lung Cancer
NCT ID: NCT00596648
Last Updated: 2013-09-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1/PHASE2
92 participants
INTERVENTIONAL
2007-12-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Phase 1 Arm
Escalating doses of XL184 + erlotinib
XL184
Capsules administered orally daily
erlotinib
Tablets administered orally daily.
Phase 2 Arm 1
XL184 + erlotinib (dose determined from Phase 1 portion of study)
XL184
Capsules administered orally daily
erlotinib
Tablets administered orally daily.
Phase 2 Arm 2
XL184 administered as a single agent
XL184
Capsules administered orally daily
Interventions
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XL184
Capsules administered orally daily
erlotinib
Tablets administered orally daily.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Exelixis
INDUSTRY
Responsible Party
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Locations
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Katmai Oncology Group
Anchorage, Alaska, United States
Stanford University Medical Center
Palo Alto, California, United States
University of California, Davis
Sacramento, California, United States
Yale University School of Medicine
New Haven, Connecticut, United States
Georgetown University/Lombardi Comprehensive Cancer Center
Washington D.C., District of Columbia, United States
University of Chicago Medical Center
Chicago, Illinois, United States
Dana Farber Cancer Institute
Boston, Massachusetts, United States
Park Nicollet Institute
Saint Louis Park, Minnesota, United States
Summit Medical Group
Berkeley Heights, New Jersey, United States
Case Western Reserve University
Cleveland, Ohio, United States
MD Anderson Cancer Center
Houston, Texas, United States
Swedish Cancer Institute
Seattle, Washington, United States
University of Washington/ Seattle Cancer Care Alliance
Seattle, Washington, United States
Countries
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Other Identifiers
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XL184-202
Identifier Type: -
Identifier Source: org_study_id