Study of XL820 in Adults With Solid Tumors

This study has been completed.
Information provided by:
Exelixis Identifier:
First received: August 10, 2005
Last updated: June 2, 2008
Last verified: June 2008

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

Condition Intervention Phase
Drug: XL820
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Masking: 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

Further study details as provided by Exelixis:

Study Start Date: August 2005

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  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: NCT00129571

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

No publications provided Identifier: NCT00129571     History of Changes
Other Study ID Numbers: XL820-001
Study First Received: August 10, 2005
Last Updated: June 2, 2008
Health Authority: United States: Food and Drug Administration processed this record on October 07, 2015