Ceramide NanoLiposome in Patients With Advanced Solid Tumors

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

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

Lead Organization
Keystone Nano, Inc

Primary ID KNAN1001
Secondary IDs NCI-2016-02016, R44CA195793
Clinicaltrials.gov ID NCT02834611