Study of XL184 (Cabozantinib) in Adults With Advanced Malignancies

Last updated: February 26, 2013
Sponsor: Exelixis
Overall Status: Completed

Phase

1

Condition

Neoplasms

Lymphoma

Cancer

Treatment

N/A

Clinical Study ID

NCT00215605
XL184-001
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Histologically confirmed advanced malignancy (solid tumor or lymphoma) that ismetastatic or unresectable for which standard curative measures do not exist or are nolonger 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 3months after completion of study

  • In the MTD expanded cohort: at least 20 subjects with metastatic and/oradvanced/locally recurrent Medullary Thyroid Cancer not appropriate for surgicalresection with measurable disease as defined by RECIST

Exclusion

Exclusion Criteria:

  • Chemotherapy, immunotherapy or radiation within 4 weeks (or nitrosoureas or mitomycinC 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 othermedications 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

Study Design

Total Participants: 85
Study Start date:
September 01, 2005
Estimated Completion Date:
July 31, 2012

Connect with a study center

  • University of Chicago

    Chicago, Illinois 60637
    United States

    Site Not Available

  • Johns Hopkins University

    Baltimore, Maryland 21231
    United States

    Site Not Available

  • Memorial Sloan Kettering Cancer Center

    New York, New York 10021
    United States

    Site Not Available

  • Fox Chase Cancer Center

    Philadelphia, Pennsylvania 19111
    United States

    Site Not Available

  • Univ. of Texas MD Anderson Cancer Center

    Houston, Texas 77030
    United States

    Site Not Available

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