Ceramide NanoLiposome in Patients With Advanced Solid Tumors
Phase I Study of C6 Ceramide NanoLiposome in Patients With Advanced Solid Tumors
Sponsor study identifier
Secondary identifiers
NIH
interventional
14
1 country
3
Study Start
March 15, 2017
Actual (reported)Primary Completion
August 3, 2023
Actual (reported)Study Completion
November 1, 2023
Actual (reported)This study is a dose escalation study of Ceramide NanoLiposome in patients with advanced solid tumors.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
November 1, 2023
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 11, 2016
Actual (reported)July 15, 2016
Actual (reported)March 15, 2017
Actual (reported)August 3, 2023
Actual (reported)November 1, 2023
Actual (reported)Maximum tolerated dose of Ceramide NanoLiposome in patients with advanced solid tumors.
24 months
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
Dose escalation of Ceramide NanoLiposome
Intravenous administration of Ceramide NanoLiposome
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
University of Maryland, Greenebaum Cancer Center
Baltimore, Maryland, 21201, United States
Medical University of South Carolina, Hollings Cancer Center
Charleston, South Carolina, 29425, United States
University of Virginia Cancer Center
Charlottesville, Virginia, 22908, United States
Ciner A, Gourdin T, Davidson J, Parette M, Walker SJ, Fox TE, Jiang Y. A phase I study of the ceramide nanoliposome in patients with advanced solid tumors. Cancer Chemother Pharmacol. 2024 Jan;93(1):23-29. doi: 10.1007/s00280-023-04588-7. Epub 2023 Sep 22.
Edward Sausville, MD, PhD
University of Maryland Greenebaum Cancer Center
14 participants (actual enrollment reported by the registry).
First Submitted
July 11, 2016
First Posted
July 15, 2016
Study Start
March 15, 2017
Actual (reported)Primary Completion
Phase I Trial of 4'-Thio-2'-Deoxycytidine (TdCyd) in Patients With Advanced Solid Tumors
Contact the study team to confirm eligibility.
August 3, 2023
Actual (reported)Study Completion
November 1, 2023
Actual (reported)Last Updated
May 29, 2024
Record last verified: 2024-05
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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