Ceramide NanoLiposome in Patients With Advanced Solid Tumors

• Sponsor: Keystone Nano, Inc (Industry)
• Overall Status: Unknown status
• CT.gov ID: NCT02834611
• Collaborator: National Institutes of Health (NIH) (NIH), National Cancer Institute (NCI) (NIH)
• Enrollment: 24
• Locations: 3
• Arm: 1
• Anticipated Duration (Months): 28.6
• Patients Per Site: 8
• Patients Per Site Per Month: 0.3

Study Details

Study Description

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 24 participants
• Allocation: N/A
• 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: Mar 15, 2017
• Anticipated Primary Completion Date: Aug 1, 2019
• Anticipated Study Completion Date: Aug 1, 2019

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Maximum tolerated dose of Ceramide NanoLiposome in patients with advanced solid tumors. [24 months]

Secondary Outcome Measures

1. Recommended phase II dose [24 months]

2. Incidence of treatment-related adverse events as assessed by CTCAE v4.0 [24 months]

3. Peak plasma concentration (Cmax) [24 months]

4. Time to maximum plasma concentration (Tmax) [24 months]

5. Ceramide NanoLiposome half-life (t1/2) [24 months]

6. Objective response rate per RECIST v1.1 [24 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• 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.

• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Maryland, Greenebaum Cancer Center	Baltimore	Maryland	United States	21201
2	Medical University of South Carolina, Hollings Cancer Center	Charleston	South Carolina	United States	29425
3	University of Virginia Cancer Center	Charlottesville	Virginia	United States	22908

Sponsors and Collaborators

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

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Keystone Nano, Inc
• ClinicalTrials.gov Identifier: NCT02834611
• Other Study ID Numbers: KNAN1001; R44CA195793
• First Posted: Jul 15, 2016
• Last Update Posted: Feb 27, 2019
• Last Verified: Feb 1, 2019

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Neoplasms

Study Results

No Results Posted as of Feb 27, 2019