Phase I and Pharmacokinetic Study of Mitoxantrone Hydrochloride Liposome Injection

Phase I and Pharmacokinetic Study of Mitoxantrone Hydrochloride Liposome Injection in Patients With Solid Tumor

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02043756

Enrollment

Registered

2014-01-23

Start date

2011-08-31

Completion date

2013-08-31

Last updated

2014-01-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neoplasms

Keywords

Mitoxantrone Hydrochloride Liposome Injection

Brief summary

The purpose of the study is to examine the toxicity profile, maximum tolerated dose (MTD), and pharmacokinetics of Mitoxantrone Hydrochloride Liposome Injection.

Detailed description

The trial of the dose escalation method is from the minimum dose until the maximum tolerated dose and every 3 patient is a dose group.

Interventions

DRUGMitoxantrone Hydrochloride Liposome

6-16mg/m2, IV ,one time of each 28 day cycle,3 cycles

DRUGMitoxantrone

10mg/m2, IV ,on day 1 of each 28 day,3 cycles

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

Inclusion criteria

* Patients must compliance with the requirements and restrictions listed in the consent form * Patients with Pathology and / or cytologically proven malignant solid tumor * Patients must be 18-70 years old ,both male and female * Failure of standard chemotherapy * Patients have no better choice and may be benefit from the use of anthracyclines * Patients must have Eastern Cooperative Oncology Group (ECOG)Performance Status of 0-2 * Objective tumor from the last chemotherapy, biological therapy or other experimental interval treatment least 4 weeks * Expected survival time ≥ 3 months * Patients agreed to take effective contraceptive measures during the trial * Blood routine, liver and kidney function, cardiac function examination in accordance with the following requirements.

Exclusion criteria

* Pregnancy and breast-feeding women * Multiple sclerosis * Patients that have histories of ischemic heart disease and heart congestive,arrhythmia that need to be a treatment and significant valvular disease * Patients with heart disease induced by anthracycline * Patients requiring other antineoplastic treatment * Patients with temperature above 38 degrees or active infection that may effects in clinical tests * Patients are allergic to anthracycline and liposomal drugs * Patients are allergic to eggs,egg products,soybean and soybean products * Patients with uncontrolled primary or metastatic brain tumors

Design outcomes

Primary

Measure	Time frame
To determination the maximal tolerance dose and dose-limiting toxicity of Mitoxantrone Hydrochloride Liposome	3 Weeks

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 8, 2026