Ceramide NanoLiposome in Patients With Advanced Solid Tumors

NCT02834611 | Completed Phase 1 DMC FDA Drug

• 2 other identifiers: KNAN1001R44CA195793
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 3

Brief Summary

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

Conditions

Cancer; Carcinoma; Solid Tumors; Tumor

Outcome Measures

Primary Outcomes (1)

• Maximum tolerated dose of Ceramide NanoLiposome in patients with advanced solid tumors.

  24 months

Secondary Outcomes (6)

• 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

Study Arms (1)

Ceramide NanoLiposome

EXPERIMENTAL

Dose escalation of Ceramide NanoLiposome

Drug: Ceramide NanoLiposome

Interventions

Ceramide NanoLiposome DRUG

Intravenous administration of Ceramide NanoLiposome

Ceramide NanoLiposome

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed informed consent/authorization is obtained prior to conducting any study-specific screening procedures.
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Keystone Nano, Inc: lead
• National Institutes of Health (NIH): collaborator
• National Cancer Institute (NCI): collaborator

Study Sites (3)

University of Maryland, Greenebaum Cancer Center

Baltimore, Maryland, 21201, United States

Location

Medical University of South Carolina, Hollings Cancer Center

Charleston, South Carolina, 29425, United States

Location

University of Virginia Cancer Center

Charlottesville, Virginia, 22908, United States

Location

Related Publications (1)

• 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.

  PMID: 37736793 DERIVED

MeSH Terms

Conditions

Neoplasms; Carcinoma

Condition Hierarchy (Ancestors)

Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Study Officials

• Edward Sausville, MD, PhD

  University of Maryland Greenebaum Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 11, 2016
• First Posted: July 15, 2016
• Study Start: March 15, 2017
• Primary Completion: August 3, 2023
• Study Completion: November 1, 2023
• Last Updated: May 29, 2024

Record last verified: 2024-05

Locations

US (3)