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| Name | Class |
|---|---|
| The University of Texas Health Science Center at San Antonio | OTHER |
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment population | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CZ48 | Drug | CZ48 is an analog of the topoisomerase I inhibitor Camptothecin (CPT). CPT is a natural extract from the tree Camptotheca acuminata |
|
| Measure | Description | Time Frame |
|---|---|---|
| To describe the dose limiting toxicities as a measure of the adverse event profile | To describe the dose limiting toxicities and adverse event profile of Camptothecin-20-O-Propionate hydrate (CZ48) administered orally for 1 course of treatment. | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Determine the Maximum Tolerated Dose (MTD) | Using the adverse event profile, the MTD will be established. | 4 weeks |
| Measure the Maximum Concentration (Cmax) level of drug in the blood plasma | To measure the blood plasma levels of study drug at various time points to determine Cmax. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Doug Coil, BS | Contact | 832-283-7705 | dougc@caopharmaceuticals.com | |
| Zhisong Cao, Ph.D. | Contact | 832-715-1039 | zhisongc@caopharmaceuticals.com |
| Name | Affiliation | Role |
|---|---|---|
| Zhisong Cao, Ph. D. | Cao Pharmaeuticals Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Texas Health Science Center | Recruiting | San Antonio | Texas | 78229 | United States |
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| Label | URL |
|---|---|
| A study of 9-nitrocamptothecin (RFS-2000) in patients with advanced pancreatic cancer | View source |
| Structure-Activity Relationship of Alkyl 9-Nitrocamptothecin Esters | View source |
| Sulfuric Acid Catalyzed Preparation of Alkyl and Alkenyl Camptothecin Ester Derivatives and Antitumor Activity against Human Xenografts Grown in Nude Mice |
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|
| 4 weeks |
| Measure the Area Under the Curve (AUC) level of drug in the blood plasma | To measure the blood plasma levels of study drug at various time points to determine AUC. | 4 weeks |
| Objective response | To assess responses by RECIST criteria when applicable | 3 months |
| Survival | To follow patients for survival. | 18 months (measured) |
| View source |
| Metabolic Difference of CZ48 in Human and Mouse Liver Microsomes | View source |
| Antitumor activity of new haloalkyl camptothecin esters against human cancer cell lines and human xenografts grown in nude mice | View source |
| Enhanced Lactone Stability of CZ48 in Blood Correlates to its Lack of Toxicity in Mice | View source |