Safety Study of Camptothecin-20-O-Propionate Hydrate (CZ48)
- 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.
- 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.
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.
Trial Phase Phase I
Trial Type Basic science
Cao Pharmaceuticals Inc.
- Primary ID CZ48-01
- Secondary IDs NCI-2015-01954
- Clinicaltrials.gov ID NCT02575638