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Ceramide NanoLiposome in Patients With Advanced Solid Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02834611
Recruitment Status : Recruiting
First Posted : July 15, 2016
Last Update Posted : September 12, 2017
National Institutes of Health (NIH)
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Keystone Nano, Inc

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

Condition or disease Intervention/treatment Phase
Cancer Carcinoma Solid Tumors Tumor Drug: Ceramide NanoLiposome Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I Study of C6 Ceramide NanoLiposome in Patients With Advanced Solid Tumors
Actual Study Start Date : March 15, 2017
Estimated Primary Completion Date : March 2019
Estimated Study Completion Date : March 2019

Arm Intervention/treatment
Experimental: Ceramide NanoLiposome
Dose escalation of Ceramide NanoLiposome
Drug: Ceramide NanoLiposome
Intravenous administration of Ceramide NanoLiposome

Primary Outcome Measures :
  1. Maximum tolerated dose of Ceramide NanoLiposome in patients with advanced solid tumors. [ Time Frame: 24 months ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02834611

Contact: Keystone Nano, Inc. Clinical Trials Information

United States, Maryland
University of Maryland, Greenebaum Cancer Center Recruiting
Baltimore, Maryland, United States, 21201
Contact: Cheryl Young    410-328-8611   
United States, South Carolina
Medical University of South Carolina, Hollings Cancer Center Recruiting
Charleston, South Carolina, United States, 29425
Contact: Alan Brisendine    843-792-9007   
United States, Virginia
University of Virginia Cancer Center Recruiting
Charlottesville, Virginia, United States, 22908
Contact: Sue Jones    434-924-9199   
Sponsors and Collaborators
Keystone Nano, Inc
National Institutes of Health (NIH)
National Cancer Institute (NCI)
Principal Investigator: Edward Sausville, MD, PhD University of Maryland Greenebaum Cancer Center

Responsible Party: Keystone Nano, Inc Identifier: NCT02834611     History of Changes
Other Study ID Numbers: KNAN1001
R44CA195793 ( U.S. NIH Grant/Contract )
First Posted: July 15, 2016    Key Record Dates
Last Update Posted: September 12, 2017
Last Verified: September 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms: