Phase I Study of Oral ST1481 Administered Once Weekly Every 3 Out 4 Weeks in Patients With Advanced Solid Malignancies.
Phase 1
18 Years
N/A
18 Years
N/A
Not Enrolling
Both
Solid Malignancies
Both
Solid Malignancies
Trial Information
Phase I Study of Oral ST1481 Administered Once Weekly Every 3 Out 4 Weeks in Patients With Advanced Solid Malignancies.
Inclusion Criteria
Inclusion criteria:
- Histologically/cytologically proven advanced solid tumors
- Life expectancy of at least 3 months with normal hematological, liver and renal
function
Exclusion criteria:
- Pregnant and lactating patients
- Participation in any investigating drug study within 4 weeks preceding treatment
start or concurrent treatment with any other anti-cancer therapy
- Gastrointestinal dysfunction that could alter absorption or motility
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Authority:
United States: Food and Drug Administration
Study ID:
ST 01-401
NCT ID:
NCT00033202
Start Date:
March 2002
Completion Date:
February 2005
Related Keywords:
- Solid Malignancies
- Solid Tumor
- Camptothecin
- Pharmacokinetics
- Neoplasms
Name | Location |
|---|---|
| Rhode Island Hospital | Providence, Rhode Island 02903 |
| Dana-Farber Cancer Institute | Boston, Massachusetts 02115 |
| Massachusetts General Hospital | Boston, Massachusetts 02114-2617 |
