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


Phase 1
18 Years
N/A
Not Enrolling
Both
Cancer

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

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

Authority:

United States: Food and Drug Administration

Study ID:

XL820-001

NCT ID:

NCT00129571

Start Date:

August 2005

Completion Date:

Related Keywords:

  • Cancer

Name

Location

Cancer Therapy and Research CenterSan Antonio, Texas  78229
The Cancer Institute of New JerseyNew Brunswick, New Jersey  08901