Phase I and Pharmacokinetics Study to Determine the Safety of CHS 828 in Patients With a Solid Tumor on a Single Oral Dose Repeated Every 3 Weeks
- Determine the maximum tolerated dose of oral CHS 828 in patients with solid tumors.
- Determine the qualitative and quantitative toxic effects of this regimen in these
- Determine a safe dose of this regimen for phase II evaluation.
- Determine the pharmacokinetic profile of this regimen in these patients.
- Determine any antitumor activity in these patients.
OUTLINE: Patients receive oral CHS 828 every 3 weeks. Treatment continues for at least 2
courses in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of CHS 828 until the maximum tolerated dose
(MTD) is reached. The MTD is defined as the dose at which 2 of 6 patients experience dose
Patients are followed for up to 4 weeks.
PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study within 12 months.
Primary Purpose: Treatment
Thomas Cerny, MD
Kantonsspital St. Gallen
United States: Federal Government