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Study of XL820 in Adults With Solid Tumors

This study has been completed.
Sponsor:
Information provided by:
Exelixis
ClinicalTrials.gov Identifier:
NCT00129571
First received: August 10, 2005
Last updated: June 2, 2008
Last verified: June 2008
History of Changes
  Purpose

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
Cancer
 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

Resource links provided by NLM:

MedlinePlus related topics: Cancer
U.S. FDA Resources

Further study details as provided by Exelixis:

Study Start Date: August 2005
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

ClinicalTrials.gov 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

ClinicalTrials.gov processed this record on May 16, 2013