Study of XL999 in Adults With Solid Tumors
Phase 1
Completed
- Conditions
- Cancer
- Registration Number
- NCT00104117
- Lead Sponsor
- Symphony Evolution, Inc.
- Brief Summary
The purpose of this study is to assess the safety and tolerability of XL999 in adults with advanced solid tumors.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 52
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method 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 Inclusion until 30 days post last treatment
- Secondary Outcome Measures
Name Time Method To evaluate plasma pharmacokinetics (PK) and estimate renal elimination of XL999 administered as a single 4-hour IV infusion in subjects with solid tumors Various timepoints from pre-dosing until 48 hours post dose. To evaluate the PK of XL999 administered at a fixed weekly dose of 200 mg. At various timepoints from pre-dosing until 48 hours post dosing
Trial Locations
- Locations (2)
Case Western Reserve University, Univserzity Hospitals of Cleveland
🇺🇸Cleveland, Ohio, United States
Cancer Therapy and Research Center, Institute for Drug Development
🇺🇸San Antonio, Texas, United States
Case Western Reserve University, Univserzity Hospitals of Cleveland🇺🇸Cleveland, Ohio, United States