A Phase 1 Dose Escalation Study of the Safety, Pharmacokinetics, and Pharmacodynamics of XL999 Administered Intravenously to Subjects With Solid Tumors
Phase 1
18 Years
N/A
18 Years
N/A
Not Enrolling
Both
Cancer
Both
Cancer
Trial Information
A Phase 1 Dose Escalation Study of the Safety, Pharmacokinetics, and Pharmacodynamics of XL999 Administered Intravenously to Subjects With Solid Tumors
Inclusion Criteria:
- Advanced solid tumor
- Cancer that has progressed on currently available therapies
- 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 within 4 weeks 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, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
To determine the maximum tolerated dose (MTD) and to assess the safety and tolerability of XL999 administered as a single 4-hour intravenous (IV) infusion in subjects with solid tumors
Outcome Time Frame:
Inclusion until 30 days post last treatment
Safety Issue:
Yes
Principal Investigator
Paul Woodard, MD
Investigator Role:
Study Director
Investigator Affiliation:
Exelixis, Inc.
Authority:
United States: Food and Drug Administration
Study ID:
XL999-001
NCT ID:
NCT00104117
Start Date:
November 2004
Completion Date:
October 2008
Related Keywords:
- Cancer
Name | Location |
|---|---|
| Cancer Therapy and Research Center, Institute for Drug Development | San Antonio, Texas 78229 |
| Case Western Reserve University, Univserzity Hospitals of Cleveland | Cleveland, Ohio 44106 |
