Ceramide NanoLiposome in Patients With Advanced Solid Tumors

Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02834611
• Other study ID #: KNAN1001
• Secondary ID: R44CA195793
• Status: Completed
• Phase: Phase 1
• Start date: March 15, 2017
• Est. completion date: November 1, 2023

Study information

• Verified date: May 2024
• Source: Keystone Nano, Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: November 1, 2023
• Est. primary completion date: August 3, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer
• Carcinoma
• Neoplasms
• Solid Tumors
• Tumor

Intervention

Drug:
• Ceramide NanoLiposome
Intravenous administration of Ceramide NanoLiposome

Locations

Country	Name	City	State
United States	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

Sponsors (3)

Lead Sponsor	Collaborator
Keystone Nano, Inc	National Cancer Institute (NCI), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum tolerated dose of Ceramide NanoLiposome in patients with advanced solid tumors.		24 months
Secondary	Recommended phase II dose		24 months
Secondary	Incidence of treatment-related adverse events as assessed by CTCAE v4.0		24 months
Secondary	Peak plasma concentration (Cmax)		24 months
Secondary	Time to maximum plasma concentration (Tmax)		24 months
Secondary	Ceramide NanoLiposome half-life (t1/2)		24 months
Secondary	Objective response rate per RECIST v1.1		24 months