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Trial record 2 of 3 for:    XL 820

Study of XL820 Given Orally Daily to Subjects With Solid Tumors

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: NCT00350831
Recruitment Status : Completed
First Posted : July 11, 2006
Last Update Posted : August 18, 2008
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Brief Summary:
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 or disease Intervention/treatment Phase
Cancer Drug: XL820 Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 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 the KIT Inhibitor XL820 Administered Orally Daily to Subjects With Solid Tumors
Study Start Date : July 2006

Primary Outcome Measures :
  1. maximum tolerated dose
  2. safety and tolerability

Secondary Outcome Measures :
  1. plasma pharmacokinetics
  2. pharmacodynamic effects
  3. long-term safety and tolerability

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:

  • 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

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): NCT00350831

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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

Layout table for additonal information Identifier: NCT00350831     History of Changes
Other Study ID Numbers: XL820-002
First Posted: July 11, 2006    Key Record Dates
Last Update Posted: August 18, 2008
Last Verified: August 2008

Keywords provided by Exelixis:
Solid tumor