Safety Study of Camptothecin-20-O-Propionate Hydrate (CZ48)
Status:
Unknown status
Trial end date:
2020-02-01
Target enrollment:
Participant gender:
Summary
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)
Phase:
Phase 1
Details
Lead Sponsor:
Cao Pharmaceuticals Inc.
Collaborator:
The University of Texas Health Science Center at San Antonio