Ceramide NanoLiposome in Patients With Advanced Solid Tumors

Study Overview
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Brief Summary
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This study is a dose escalation study of Ceramide NanoLiposome in patients with advanced solid tumors.

Official Title
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Phase I Study of C6 Ceramide NanoLiposome in Patients With Advanced Solid Tumors

Conditions
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Cancer, Carcinoma, Solid Tumors, Tumor

Intervention / Treatment
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* Drug: Ceramide NanoLiposome


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Signed informed consent/authorization is obtained prior to conducting any study-specific screening procedures. 18 years of age or order Histologic or cytologic diagnosis of cancer Patients without a curative therapy or whose tumor does not have standard chemotherapy At least 4 weeks after the last dose of chemotherapy or radiation therapy; 6 weeks for mitoxantrone or mitomycin therapy Eastern Cooperative Oncology Group (ECOG) performance status must be ≤2 (Appendix A). 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) 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. Radiographic evidence of measurable disease tumor lesion (≥ 1cm in greatest dimension) or nodal disease (>1.5cm in greatest dimension) Men and women of all ethnic groups are eligible for this trial. Females at reproductive age must have a negative urine pregnancy test prior to entry to this study Life expectancy is greater than 12 weeks. Patients with controlled CNS disease and off steroids are eligible. Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ceramide NanoLiposome<br>Dose escalation of Ceramide NanoLiposome | Drug: Ceramide NanoLiposome<br>* Intravenous administration of Ceramide NanoLiposome<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum tolerated dose of Ceramide NanoLiposome in patients with advanced solid tumors. |  | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recommended phase II dose |  | 24 months | 
| Incidence of treatment-related adverse events as assessed by CTCAE v4.0 |  | 24 months | 
| Peak plasma concentration (Cmax) |  | 24 months | 
| Time to maximum plasma concentration (Tmax) |  | 24 months | 
| Ceramide NanoLiposome half-life (t1/2) |  | 24 months | 
| Objective response rate per RECIST v1.1 |  | 24 months |