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Study of XL184 (Cabozantinib) in Adults With Advanced Malignancies

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00215605
Recruitment Status : Completed
First Posted : September 22, 2005
Last Update Posted : February 27, 2013
Information provided by (Responsible Party):

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, 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.

Condition or disease Intervention/treatment Phase
Lymphoma Cancer Thyroid Carcinoma Drug: XL184 Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 85 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1 Dose-Escalation Study of the Safety and Pharmacokinetics of XL184 Administered Orally to Subjects With Advanced Malignancies
Study Start Date : September 2005
Actual Primary Completion Date : April 2011
Actual Study Completion Date : July 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Thyroid Cancer

Arm Intervention/treatment
Experimental: 1 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)

Primary Outcome Measures :
  1. Safety, tolerability, maximum tolerated dose (MTD), and dose-limiting toxicity of oral administration of XL184 [ Time Frame: Assessed during periodic visits ]
  2. Evaluate plasma pharmacokinetics and estimate renal elimination of oral administration of XL184 [ Time Frame: Assessed during periodic visits ]

Secondary Outcome Measures :
  1. Long-term safety/tolerability of XL184 after oral administration for up to 1 year [ Time Frame: Assessed during periodic visits ]
  2. Evaluate preliminary tumor response after repeated XL184 administration [ Time Frame: Assessed during periodic visits ]
  3. In MTD expanded cohort: Progression-free survival and duration of response in subjects with advanced or recurrent medullary thyroid cancer [ Time Frame: Assessed during periodic visits ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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 Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00215605

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United States, Illinois
University of Chicago
Chicago, Illinois, United States, 60637
United States, Maryland
Johns Hopkins University
Baltimore, Maryland, United States, 21231
United States, New York
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10021
United States, Pennsylvania
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111
United States, Texas
Univ. of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Exelixis Identifier: NCT00215605     History of Changes
Obsolete Identifiers: NCT00354289
Other Study ID Numbers: XL184-001
First Posted: September 22, 2005    Key Record Dates
Last Update Posted: February 27, 2013
Last Verified: February 2013
Keywords provided by Exelixis:
Advanced Malignancies
Solid Tumor
Medullary Thyroid Cancer
Additional relevant MeSH terms:
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Thyroid Neoplasms
Thyroid Diseases
Endocrine System Diseases
Endocrine Gland Neoplasms
Neoplasms by Site
Head and Neck Neoplasms