Ceramide NanoLiposome in Patients With Advanced Solid Tumors

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

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

Study Overview

• Status: Completed
• Conditions: Carcinoma; Cancer; Solid Tumors; Tumor
• Intervention / Treatment: Drug: Ceramide NanoLiposome

• Study Type: Interventional
• Enrollment (Actual): 14
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • University of Maryland, Greenebaum Cancer Center
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Medical University of South Carolina, Hollings Cancer Center
  • Virginia
    • Charlottesville, Virginia, United States, 22908
      • University of Virginia Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ceramide NanoLiposome; Dose escalation of Ceramide NanoLiposome	Drug: Ceramide NanoLiposome; Intravenous administration of Ceramide NanoLiposome

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Keystone Nano, Inc
• Collaborators: National Cancer Institute (NCI); National Institutes of Health (NIH)
• Investigators: Principal Investigator: Edward Sausville, MD, PhD, University of Maryland Greenebaum Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): March 15, 2017
• Primary Completion (Actual): August 3, 2023
• Study Completion (Actual): November 1, 2023

Study Registration Dates

• First Submitted: July 11, 2016
• First Submitted That Met QC Criteria: July 12, 2016
• First Posted (Estimated): July 15, 2016

Study Record Updates

• Last Update Posted (Actual): May 29, 2024
• Last Update Submitted That Met QC Criteria: May 27, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: KNAN1001; R44CA195793 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No