Study of XL184 (Cabozantinib) in Adults With Advanced Malignancies

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Brief Title

Study of XL184 (Cabozantinib) in Adults With Advanced Malignancies

Official Title

A Phase 1 Dose-Escalation Study of the Safety and Pharmacokinetics of XL184 Administered Orally to Subjects With Advanced Malignancies

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.
    


Study Phase

Phase 1

Study Type

Interventional


Primary Outcome

Safety, tolerability, maximum tolerated dose (MTD), and dose-limiting toxicity of oral administration of XL184

Secondary Outcome

 Long-term safety/tolerability of XL184 after oral administration for up to 1 year

Condition

Lymphoma

Intervention

XL184

Study Arms / Comparison Groups

 1
Description:  

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

85

Start Date

September 2005

Completion Date

July 2012

Primary Completion Date

April 2011

Eligibility Criteria

        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 					

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT00215605

Organization ID

XL184-001


Responsible Party

Sponsor

Study Sponsor

Exelixis


Study Sponsor

, , 


Verification Date

February 2013