Safety Study of Camptothecin-20-O-Propionate Hydrate (CZ48)
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ClinicalTrials.gov Identifier: NCT02575638 |
Recruitment Status :
Recruiting
First Posted : October 15, 2015
Last Update Posted : July 23, 2019
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Condition or disease | Intervention/treatment | Phase |
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Malignant Lymphoma of Extranodal and/or Solid Organ Site Solid Tumor | Drug: CZ48 | Phase 1 |
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.
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 65 participants |
Allocation: | N/A |
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 |

Arm | Intervention/treatment |
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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.
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Drug: CZ48
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.

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patients must have a Performance Status (Zubrod) performance status of 0-1
- Patients must sign an informed consent document
- Patients should have adequate bone marrow function defined by an absolute peripheral granulocyte count of > 1,500 /mm3 and platelet count >100,000/mm3 along with an absence of a red blood cell transfusion in the two weeks prior to their participation in the trial
- Patients should have adequate hepatic function with a total bilirubin within normal range and serum glutamate oxaloacetate transaminase (SGOT) or serum glutamate pyruvate transaminase (SGPT) < two times the upper limit of normal (ULN) for patients without liver metastasis and SGOT or SGPT < five times ULN for those with liver metastasis, and adequate renal function as defined by a serum creatinine within 1.5 times the upper limit of normal.
- Patients may receive no other concurrent anticancer treatments such as chemotherapy, hormone therapy (except for prostate cancer patients on luteinizing hormone-releasing hormone ((LHRH)) agonists), immunotherapy, biological agents, investigational agents, or radiation therapy during this trial, and should be off these treatments for at least 2 weeks, or until they have completely recovered from the side effects of these treatments, whichever is longest, except for persistent grade 1 neuropathy in patients who received prior platinum or taxanes.
Exclusion Criteria:
- Patients with symptomatic brain metastases are excluded from this study.
- Patients with brain metastasis that have been treated, asymptomatic and off any steroid use are permitted for study
- Pregnant women or nursing mothers are not eligible for this trial. Patients of child bearing potential must use adequate contraception (contraceptive pill, or intrauterine device ((IUD)), or two mechanical barriers).
- Patients with severe uncontrolled medical problems are not eligible for this trial.
- Patients who have too much esterase as determined by a pre-screen dose, with a conversion rate yielding concentration of CPT > 100 ng/ml in vitro.

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, BS | 832-283-7705 | dougc@caopharmaceuticals.com | |
Contact: Zhisong Cao, Ph.D. | 832-715-1039 | zhisongc@caopharmaceuticals.com |
United States, Texas | |
University of Texas Health Science Center | Recruiting |
San Antonio, Texas, United States, 78229 | |
Contact: CTRCReferral@uthscsa.edu | |
Principal Investigator: John Sarantopoulos, M.D. |
Principal Investigator: | Zhisong Cao, Ph. D. | Cao Pharmaeuticals Inc. |
Responsible Party: | Cao Pharmaceuticals Inc. |
ClinicalTrials.gov Identifier: | NCT02575638 |
Other Study ID Numbers: |
CZ48-01 |
First Posted: | October 15, 2015 Key Record Dates |
Last Update Posted: | July 23, 2019 |
Last Verified: | July 2019 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Lymphoma Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases |
Camptothecin Antineoplastic Agents, Phytogenic Antineoplastic Agents Topoisomerase I Inhibitors Topoisomerase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |