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Study of XL820 Given Orally Daily to Subjects With Solid Tumors

This study has been completed.
Information provided by:
Exelixis Identifier:
First received: July 7, 2006
Last updated: August 14, 2008
Last verified: August 2008
The purpose of this study is to assess the safety and tolerability of the KIT inhibitor XL820 when given orally daily to adults with advanced solid tumors.

Condition Intervention Phase
Cancer Drug: XL820 Phase 1

Study Type: Interventional
Study Design: 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 the KIT Inhibitor XL820 Administered Orally Daily to Subjects With Solid Tumors

Further study details as provided by Exelixis:

Primary Outcome Measures:
  • maximum tolerated dose
  • safety and tolerability

Secondary Outcome Measures:
  • plasma pharmacokinetics
  • pharmacodynamic effects
  • long-term safety and tolerability

Estimated Enrollment: 30
Study Start Date: July 2006

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

Inclusion Criteria:

  • Subject has a histologically confirmed solid tumor that is metastatic or unresectable for which known effective measures do not exist or are no longer effective, and there are no known therapies to prolong survival
  • Subject is at least 18 years old
  • Subject has ECOG performance status ≤ 2
  • Subject has a life expectancy of > 3 months
  • Subject has adequate organ and marrow function
  • In the adrenocorticotropic hormone (ACTH) stimulation test, the subject has a serum cortisol level ≥ 20 ug/dL (552 nmol/L) 30-90 minutes after injection of ACTH
  • Subject has given written informed consent
  • Sexually active subjects (male and female) must use accepted methods of contraception during the course of the study.
  • Female subjects of childbearing potential must have a negative pregnancy test at screening.

Exclusion Criteria:

  • Subject has received anticancer treatment within 30 days before the first dose of XL820, or has not recovered to grade ≤ 1 from adverse events due to agents administered more than 30 days earlier
  • Subject has received radiation to ≥ 25% of his/her bone marrow within 30 days of XL820 treatment
  • Subject has received an investigational agent within 30 days of the first dose of XL820
  • Subject has known brain metastases
  • Subject has known uncontrolled intercurrent illness
  • Subject is pregnant or lactating
  • Subject is known to be positive for HIV
  • Subject has a known allergy or hypersensitivity to any of the components of the XL820 formulation
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00350831

United States, New Jersey
The Cancer Institute of New Jersey
New Brunswick, New Jersey, United States, 08901
United States, Texas
Cancer Therapy and Research Center
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
  More Information Identifier: NCT00350831     History of Changes
Other Study ID Numbers: XL820-002
Study First Received: July 7, 2006
Last Updated: August 14, 2008

Keywords provided by Exelixis:
Solid tumor processed this record on September 25, 2017