Ceramide NanoLiposome in Patients With Advanced Solid Tumors

February 26, 2019 updated by: Keystone Nano, Inc

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

Unknown

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

24

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ceramide NanoLiposome
Dose escalation of 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.
Time Frame: 24 months
24 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Edward Sausville, MD, PhD, University of Maryland Greenebaum Cancer Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 15, 2017

Primary Completion (Anticipated)

August 1, 2019

Study Completion (Anticipated)

August 1, 2019

Study Registration Dates

First Submitted

July 11, 2016

First Submitted That Met QC Criteria

July 12, 2016

First Posted (Estimate)

July 15, 2016

Study Record Updates

Last Update Posted (Actual)

February 27, 2019

Last Update Submitted That Met QC Criteria

February 26, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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