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A Study of Mitoxantrone Hydrochloride Liposome Injection Combination Therapy in Chinese Patients With Advanced Solid Tumors

NCT05344742 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 116

Last updated 2022-04-25

No results posted yet for this study

Summary

The purpose of this study is to evaluate the tolerability, safety, pharmacokinetics (PK) and efficacy of mitoxantrone hydrochloride liposome injection combination therapy in Chinese patients with advanced solid tumors.

Conditions

  • Advanced Solid Tumor

Interventions

DRUG

Mitoxantrone Hydrochloride Liposome injection

Mitoxantrone hydrochloride liposome injection will be administered intravenously once every 3 weeks (a cycle)

DRUG

Capecitabine

The fixed dose of oral capecitabine will be administered 1000mg/m\^2, twice daily, from day 1 to day 14.

DRUG

Albumin-paclitaxel

The fixed dose of albumin-paclitaxel will be set as 260 mg/m\^2, once every three weeks.

Sponsors & Collaborators

  • CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2022-04-30
Primary Completion
2024-03-31
Completion
2025-03-31

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Drugs

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 NCT05344742 on ClinicalTrials.gov