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Safety Study of Camptothecin-20-O-Propionate Hydrate (CZ48)

NCT02575638 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 65

Last updated 2019-07-23

No results posted yet for this study

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)

Conditions

  • Malignant Lymphoma of Extranodal and/or Solid Organ Site
  • Solid Tumor

Interventions

DRUG

CZ48

CZ48 is an analog of the topoisomerase I inhibitor Camptothecin (CPT). CPT is a natural extract from the tree Camptotheca acuminata

Sponsors & Collaborators

  • The University of Texas Health Science Center at San Antonio

    collaborator OTHER

  • Cao Pharmaceuticals Inc.

    lead INDUSTRY

Principal Investigators

  • Zhisong Cao, Ph. D. · Cao Pharmaeuticals Inc.

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-07-31
Primary Completion
2019-10-01
Completion
2020-02-01

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02575638 on ClinicalTrials.gov