Safety Study of Camptothecin-20-O-Propionate Hydrate (CZ48)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02575638|
Recruitment Status : Recruiting
First Posted : October 15, 2015
Last Update Posted : July 23, 2019
|Condition or disease||Intervention/treatment||Phase|
|Malignant Lymphoma of Extranodal and/or Solid Organ Site Solid Tumor||Drug: CZ48||Phase 1|
• 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).
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||65 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||Phase I Clinical Trial of Camptothecin-20-O-Propionate Hydrate (CZ48)|
|Study Start Date :||July 2008|
|Estimated Primary Completion Date :||October 1, 2019|
|Estimated Study Completion Date :||February 1, 2020|
Experimental: Treatment population
The study drug, CZ48, is administered orally in capsule form t.i.d. Capsules in 30mg and 50mg of drug are available for dosing. This is a dose escalation study so dosage has not yet been determined. Study drug is take on day 1 - 5 and then no drug on day 6 and 7. This is repeated for 4 weeks, or one course.
CZ48 is an analog of the topoisomerase I inhibitor Camptothecin (CPT). CPT is a natural extract from the tree Camptotheca acuminata
Other Name: Camptothecin-20-O-Propionate hydrate
- To describe the dose limiting toxicities as a measure of the adverse event profile [ Time Frame: 4 weeks ]To describe the dose limiting toxicities and adverse event profile of Camptothecin-20-O-Propionate hydrate (CZ48) administered orally for 1 course of treatment.
- Determine the Maximum Tolerated Dose (MTD) [ Time Frame: 4 weeks ]Using the adverse event profile, the MTD will be established.
- Measure the Maximum Concentration (Cmax) level of drug in the blood plasma [ Time Frame: 4 weeks ]To measure the blood plasma levels of study drug at various time points to determine Cmax.
- Measure the Area Under the Curve (AUC) level of drug in the blood plasma [ Time Frame: 4 weeks ]To measure the blood plasma levels of study drug at various time points to determine AUC.
- Objective response [ Time Frame: 3 months ]To assess responses by RECIST criteria when applicable
- Survival [ Time Frame: 18 months (measured) ]To follow patients for survival.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02575638
|Contact: Doug Coil, BSemail@example.com|
|Contact: Zhisong Cao, Ph.D.||firstname.lastname@example.org|
|United States, Texas|
|University of Texas Health Science Center||Recruiting|
|San Antonio, Texas, United States, 78229|
|Principal Investigator: John Sarantopoulos, M.D.|
|Principal Investigator:||Zhisong Cao, Ph. D.||Cao Pharmaeuticals Inc.|