Solid Tumor Clinical Trial
Official title:
Phase I Clinical Trial of Camptothecin-20-O-Propionate Hydrate (CZ48)
This is a single-arm, non-randomized feasibility and Phase I trial of 20(S) Camptothecin Propionate administered orally. CZ48 will be administered in successive cohorts of 1 patient per participating site until hints of toxicity (grade 2 or worse adverse events related to the drug) are observed. Then cohorts of 3+3 patients will be treated. CZ48 will be administered orally daily (1 course = 4 weeks). No pre-medications will be administered. Patients will be asked to drink up to one gallon of fluid daily if possible to flush the bladder to mitigate cystitis. Cystitis is an anticipated toxicity as CZ48 is a pro-drug of CPT (Camptothecin)
PRIMARY OBJECTIVE:
• To describe the dose limiting toxicities and adverse event profile of
Camptothecin-20-O-Propionate hydrate (CZ48) administered orally every day for 4 weeks (1
course).
SECONDARYOBJECTIVE
- To determine the Maximum Tolerated Dose (MTD) of Camptothecin-20-O-Propionate hydrate
(CZ48).
- To determine the blood plasma levels (PK study) of orally administered CZ48.
- To assess responses by Response Evaluation Criteria in Solid Tumors (RECIST) criteria
when applicable.
- To follow patients for survival.
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