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Study of XL820 in Adults With Solid Tumors

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ClinicalTrials.gov Identifier: NCT00129571
Recruitment Status : Completed
First Posted : August 12, 2005
Last Update Posted : June 4, 2008
Sponsor:
Information provided by:
Exelixis

Brief Summary:
The purpose of this study is to assess the safety and tolerability of XL820 when given orally to adults with advanced solid tumors.

Condition or disease Intervention/treatment Phase
Cancer Drug: XL820 Phase 1

Study Type : Interventional  (Clinical Trial)
Allocation: Non-Randomized
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1 Dose Escalation Study of the Safety and Pharmacokinetics of XL820 Administered Orally to Subjects With Solid Tumors
Study Start Date : August 2005




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

Inclusion Criteria:

  • Advanced solid tumor
  • Cancer for which standard therapies do not exist or are no longer effective
  • Life expectancy of > 3 months
  • Adequate bone marrow, liver, and kidney function
  • Willing to use accepted method of contraception during the course of the study
  • Negative pregnancy test (females)
  • Written informed consent

Exclusion Criteria:

  • Chemotherapy within 4-6 weeks of the start of treatment (depending on the therapy)
  • Radiotherapy to more than 25% of bone marrow within 4 weeks of the start of treatment
  • Investigational drug within 30 days of the start of treatment
  • Subjects with known brain metastasis
  • Uncontrolled medical disorder such as infection or cardiovascular disease
  • Subjects known to be HIV positive
  • Pregnant or breastfeeding women

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 ClinicalTrials.gov identifier (NCT number): NCT00129571


Locations
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
Exelixis

ClinicalTrials.gov Identifier: NCT00129571     History of Changes
Other Study ID Numbers: XL820-001
First Posted: August 12, 2005    Key Record Dates
Last Update Posted: June 4, 2008
Last Verified: June 2008