Ceramide NanoLiposome in Patients With Advanced Solid Tumors
- Registration Number
- NCT02834611
- Lead Sponsor
- Keystone Nano, Inc
- Brief Summary
This study is a dose escalation study of Ceramide NanoLiposome in patients with advanced solid tumors.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 14
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Signed informed consent/authorization is obtained prior to conducting any study-specific screening procedures.
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18 years of age or order
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Histologic or cytologic diagnosis of cancer
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Patients without a curative therapy or whose tumor does not have standard chemotherapy
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At least 4 weeks after the last dose of chemotherapy or radiation therapy; 6 weeks for mitoxantrone or mitomycin therapy
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Eastern Cooperative Oncology Group (ECOG) performance status must be ≤2 (Appendix A).
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Adequate hepatic, renal, and bone marrow function:
- Absolute neutrophil count ≥ 1,000/microliter (uL)
- Platelets ≥ 100,000/uL
- Total bilirubin ≤2.0
- AST(SGOT)/ALT(SGPT) ≤ 2.5 X institutional ULN
- Creatinine ≤1.2 mg/dL or clearance ≥50ml/min (Cockcroft-Gault)
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All participants (male and female) with reproductive potential must practice an effective method of contraception while on this study in order to minimize risks to fetuses.
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Radiographic evidence of measurable disease tumor lesion (≥ 1cm in greatest dimension) or nodal disease (>1.5cm in greatest dimension)
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Men and women of all ethnic groups are eligible for this trial.
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Females at reproductive age must have a negative urine pregnancy test prior to entry to this study
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Life expectancy is greater than 12 weeks.
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Patients with controlled CNS disease and off steroids are eligible.
- Uncontrolled intercurrent illness including, but not limited to, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmias not well controlled with medication, myocardial infarction within the previous 6 months, or psychiatric illness/social situations that would limit compliance with study requirements.
- Patients may not be receiving any other concurrent investigational agents, or have received any investigational agent within four weeks of commencing this protocol.
- Since the teratogenic potential of this combination is currently unknown, females who are pregnant or lactating are excluded. Males and females should perform abstinence or use barrier to prevent pregnancy.
- History of any other malignancies in the last 2 years except in-situ cancer, non-muscle invasive bladder cancer, basal or squamous cell skin cancer are eligible
- Patients known to be HIV(+), Hep BsAg(+), or Hep C(+) are excluded as the effect of the agent on immune system has not been assessed
- Patients with history of hypersensitivity to liposomal products
- Patients with primary CNS malignancies or leptomeningeal disease are excluded
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Ceramide NanoLiposome Ceramide NanoLiposome Dose escalation of Ceramide NanoLiposome
- Primary Outcome Measures
Name Time Method Maximum tolerated dose of Ceramide NanoLiposome in patients with advanced solid tumors. 24 months
- Secondary Outcome Measures
Name Time Method Recommended phase II dose 24 months Peak plasma concentration (Cmax) 24 months Ceramide NanoLiposome half-life (t1/2) 24 months Incidence of treatment-related adverse events as assessed by CTCAE v4.0 24 months Time to maximum plasma concentration (Tmax) 24 months Objective response rate per RECIST v1.1 24 months
Trial Locations
- Locations (3)
University of Maryland, Greenebaum Cancer Center
🇺🇸Baltimore, Maryland, United States
Medical University of South Carolina, Hollings Cancer Center
🇺🇸Charleston, South Carolina, United States
University of Virginia Cancer Center
🇺🇸Charlottesville, Virginia, United States