Phase I and Pharmacology Study of Camptothecin-20-O-Propionate Hydrate (CZ48) in Patients With Solid Tumors or Lymphoma
Status:
Completed
Trial end date:
2014-03-01
Target enrollment:
Participant gender:
Summary
This is a phase I and pharmacology study of Camptothecin-20-O-Propionate Hydrate (CZ48) in
Patients with Solid Tumors or Lymphoma.
OBJECTIVES
Primary:
1. To describe the dose limiting toxicities and adverse event profile of
Camptothecin-20-O-Propionate hydrate (CZ48) administered orally every day.
2. To determine Phase II recommended dose of Camptothecin-20-O-Propionate hydrate (CZ48)
administered orally every day.
Secondary:
3. To perform a pharmacokinetic study of orally administered CZ48 in the plasma.
4. To assess responses by RECIST criteria.
5. To follow patients for survival.