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NCT00129571 Clinical Trial

Study of XL820 in Adults With Solid Tumors

Cancer Clinical Trial

Official title:
A Phase 1 Dose Escalation Study of the Safety and Pharmacokinetics of XL820 Administered Orally to Subjects With Solid Tumors

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00129571
Other study ID # XL820-001
Secondary ID
Status Completed
Phase Phase 1
First received August 10, 2005
Last updated June 2, 2008
Start date August 2005

Study information
Verified date June 2008
Source Exelixis
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• XL820

Locations
Country Name City State
United States The Cancer Institute of New Jersey New Brunswick New Jersey
United States Cancer Therapy and Research Center San Antonio Texas

Sponsors (1)
Lead Sponsor Collaborator
Exelixis

Country where clinical trial is conducted

United States, 

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