Status:
COMPLETED
Study of XL184 (Cabozantinib) in Adults With Advanced Malignancies
Lead Sponsor:
Exelixis
Conditions:
Lymphoma
Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
The purpose of this study is to determine the best and safest dose of XL184 administered orally. XL184 is a new chemical entity that inhibits VEGFR2, MET and RET, kinases implicated in tumor formation...
Eligibility Criteria
Inclusion
- Histologically confirmed advanced malignancy (solid tumor or lymphoma) that is metastatic or unresectable for which standard curative measures do not exist or are no longer effective
- Eastern Cooperative Oncology Group (ECOG) performance status \</= 2
- Life expectancy greater than 3 months
- Adequate organ and marrow function
- Written informed consent
- Use of acceptable methods of contraception during the course of the study and for 3 months after completion of study
- In the MTD expanded cohort: at least 20 subjects with metastatic and/or advanced/locally recurrent Medullary Thyroid Cancer not appropriate for surgical resection with measurable disease as defined by RECIST
Exclusion
- Chemotherapy, immunotherapy or radiation within 4 weeks (or nitrosoureas or mitomycin C within 6 weeks) before the first scheduled dose of XL184
- Administration of an investigational drug within 30 days of the first dose of XL184
- Subject has not recovered from adverse events due to investigational agents or other medications administered more than 4 weeks before study enrollment
- Known brain metastases
- Uncontrolled intercurrent illness
- Pregnancy or breastfeeding
- Known HIV positive
- Known allergy or hypersensitivity to any of the components of the XL184 formulation
Key Trial Info
Start Date :
September 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2012
Estimated Enrollment :
85 Patients enrolled
Trial Details
Trial ID
NCT00215605
Start Date
September 1 2005
End Date
July 1 2012
Last Update
February 27 2013
Active Locations (5)
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1
University of Chicago
Chicago, Illinois, United States, 60637
2
Johns Hopkins University
Baltimore, Maryland, United States, 21231
3
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10021
4
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111