Phase I and Pharmacokinetic Study of Mitoxantrone Hydrochloride Liposome Injection

NCT ID: NCT02043756

Last Updated: 2014-01-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-08-31
• Study Completion Date: 2013-08-31

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.

Conditions

Neoplasms

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Mitoxantrone Hydrochloride Liposome

Dose escalation will begin at 6mg/m2 to 16mg/m2,4 weeks apart

Group Type: EXPERIMENTAL

Mitoxantrone Hydrochloride Liposome

Intervention Type: DRUG

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

Mitoxantrone ,injection

When the dose of experiment drup up 10mg/m2,10mg/m2 of Mitoxantrone as active comparator

Group Type: ACTIVE_COMPARATOR

Mitoxantrone

Intervention Type: DRUG

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

Interventions

Mitoxantrone Hydrochloride Liposome

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

Intervention Type: DRUG

Mitoxantrone

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

Intervention Type: DRUG

Other Intervention Names

2010L04017; Novantrone

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yuankai Shi, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Cancer Hospital ,Chinese Academy of Mddical Sciences 010-87788701

Jianliang Yang, Ph.D

Role: STUDY_DIRECTOR

Cancer Hospital ,Chinese Academy of Mddical Sciences 010-87788121

Xiaohong Han, Ph.D

Role: STUDY_DIRECTOR

Cancer Hospital ,Chinese Academy of Mddical Sciences 010-87788701

References

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.

Reference Type: DERIVED

PMID: 25034977 (View on PubMed)

Other Identifiers

cspcmitlip

Identifier Type: -

Identifier Source: org_study_id