MedTrace Logo

Phase I Clinical Study for Evaluation of Pharmacokinetic, Safety, Tolerance of Norcantharidin Lipid Microsphere for Injection in Patients With Solid Tumor

NCT04673396 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2020-12-21

No results posted yet for this study

Summary

This study was designed as a single-center, open, non-randomized trial.

Conditions

Interventions

DRUG

Norcantharidin Lipid Microsphere for Injection

The test drug was added to 5% glucose injection to a final volume of 250 mL，and administered by instillation at a rate of 200 mL/h. This product can be used alone or in combination with chemotherapy, and the dosage and time of administration vary with the chemotherapy regimen.

DRUG

Sodium Demethylcantharidate Injection

Dissolve the reference drug with appropriate amount of sterile water for injection, and add 250 mL of 5% glucose injection for slow dripping.

Sponsors & Collaborators

  • Beijing Nuokangda Pharmaceutical Technology Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Yunpeng Liu, Ph.D · The First Affiliated Hospital, China Medical University

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-22
Primary Completion
2021-12-31
Completion
2022-07-01

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04673396 on ClinicalTrials.gov