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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
Not Enrolling
Both
Solid Malignancies

Thank you

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 HospitalProvidence, Rhode Island  02903
Dana-Farber Cancer InstituteBoston, Massachusetts  02115
Massachusetts General HospitalBoston, Massachusetts  02114-2617