Study of XL184 (Cabozantinib) in Adults With Advanced Malignancies
NCT00215605 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 85
Last updated 2013-02-27
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, growth and migration. To determine the highest safe dose, subjects will receive different amounts of the drug. The first group of subjects will receive the lowest dose of XL184. As long as no medically unacceptable side effects are noted, the dose will be increased for the next group. When the maximum tolerated dose (MTD) is reached, at least 20 subjects with Medullary Thyroid Cancer (MTC) will be enrolled to evaluate the effect of XL184 in this population.
Conditions
Interventions
- DRUG
-
XL184
Flavored liquid suspension or gelatin capsules supplied in 25-mg and 100-mg strengths; daily dosing or intermittent schedule (daily dosing followed by dosing holiday in cycles)
Sponsors & Collaborators
- lead INDUSTRY
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2005-09-30
- Primary Completion
- 2011-04-30
- Completion
- 2012-07-31
Countries
- United States
Study Locations
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