drugset
drugset / Trial / NCT00947739

Phase I and Pharmacology Study of Camptothecin-20-O-Propionate Hydrate (CZ48) in Patients With Solid Tumors or Lymphoma

NCT00947739 ↗

Phase 1 Completed 43 enrolled New Mexico Cancer Research Alliance Christus Stehlin Foundation for Cancer Research · collab
Non-randomizedSingle-groupOpen-labelTreatment

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.

Timeline

Start
2008-09
Primary completion
2012-12
Completion
2014-03

Drugs

EvaluationDrugModalityDoseRoute
Subject Camptothecin-20-O-Propionate Hydrate Unknown 18 mg/m2 Oral
Subject Camptothecin-20-O-Propionate Hydrate Unknown 36 mg/m2 Oral
Subject Camptothecin-20-O-Propionate Hydrate Unknown 72 mg/m2 Oral
Subject Camptothecin-20-O-Propionate Hydrate Unknown 80 mg/m2 Oral
Subject Camptothecin-20-O-Propionate Hydrate Unknown 144 mg/m2 Oral
Subject Camptothecin-20-O-Propionate Hydrate Unknown 160 mg/m2 Oral
Subject Camptothecin-20-O-Propionate Hydrate Unknown 288 mg/m2 Oral
Subject Camptothecin-20-O-Propionate Hydrate Unknown 320 mg/m2 Oral
Subject Camptothecin-20-O-Propionate Hydrate Unknown 576 mg/m2 Oral
Subject Camptothecin-20-O-Propionate Hydrate Unknown 640 mg/m2 Oral
Subject Camptothecin-20-O-Propionate Hydrate Unknown 750 mg/m2 Oral
Subject Camptothecin-20-O-Propionate Hydrate Unknown 1000 mg/m2 Oral
Subject Camptothecin-20-O-Propionate Hydrate Unknown 1280 mg/m2 Oral
Subject Camptothecin-20-O-Propionate Hydrate Unknown 2560 mg/m2 Oral

Indications

cancer lymphoma