- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02834611
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
Conditions
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
- Name: Keystone Nano, Inc. Clinical Trials Information
- Phone Number: 8144665080
- Email: clinicaltrials@keystonenano.com
Study Locations
-
-
Maryland
-
Baltimore, Maryland, United States, 21201
- Recruiting
- University of Maryland, Greenebaum Cancer Center
-
Contact:
- Joann Alimurong
- Email: joann.alimurong@umm.edu
-
-
South Carolina
-
Charleston, South Carolina, United States, 29425
- Recruiting
- Medical University of South Carolina, Hollings Cancer Center
-
Contact:
- Alan Brisendine
- Phone Number: 843-792-9007
- Email: brisend@musc.edu
-
-
Virginia
-
Charlottesville, Virginia, United States, 22908
- Recruiting
- University of Virginia Cancer Center
-
Contact:
- Sue Jones
- Phone Number: 434-924-9199
- Email: syt8a@virginia.edu
-
-
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.
Sponsor
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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