Clinical trial NCT02043756: Phase I and Pharmacokinetic Study of Mitoxantrone Hydrochloride Liposome Injection
Official title: Phase I and Pharmacokinetic Study of Mitoxantrone Hydrochloride Liposome Injection in Patients With Solid Tumor
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Neoplasms
Keywords: Mitoxantrone Hydrochloride Liposome Injection
Lead sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2014-01-23
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: To determination the maximal tolerance dose and dose-limiting toxicity of Mitoxantrone Hydrochloride Liposome
timeFrame: 3 Weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Cancer Hospital ,Chinese Academy of Mddical Sciences 010-87788701
name: Yuankai Shi, Ph.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Cancer Hospital ,Chinese Academy of Mddical Sciences 010-87788121
name: Jianliang Yang, Ph.D
role: STUDY_DIRECTOR
affiliation: Cancer Hospital ,Chinese Academy of Mddical Sciences 010-87788701
name: Xiaohong Han, Ph.D
role: STUDY_DIRECTOR
References:
citation: Yang J, Shi Y, Li C, Gui L, Zhao X, Liu P, Han X, Song Y, Li N, Du P, Zhang S. Phase I clinical trial of pegylated liposomal mitoxantrone plm60-s: pharmacokinetics, toxicity and preliminary efficacy. Cancer Chemother Pharmacol. 2014 Sep;74(3):637-46. doi: 10.1007/s00280-014-2523-8. Epub 2014 Jul 18.