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Phase I and Pharmacokinetic Study of Mitoxantrone Hydrochloride Liposome Injection

Information source: CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Neoplasms

Intervention: Mitoxantrone Hydrochloride Liposome (Drug); Mitoxantrone (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

Official(s) and/or principal investigator(s):
Yuankai Shi, Ph.D, Principal Investigator, Affiliation: Cancer Hospital ,Chinese Academy of Mddical Sciences 010-87788701
Jianliang Yang, Ph.D, Study Director, Affiliation: Cancer Hospital ,Chinese Academy of Mddical Sciences 010-87788121
Xiaohong Han, Ph.D, Study Director, Affiliation: Cancer Hospital ,Chinese Academy of Mddical Sciences 010-87788701

Summary

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

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Primary outcome: To determination the maximal tolerance dose and dose-limiting toxicity of Mitoxantrone Hydrochloride Liposome

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

Minimum age: 18 Years. Maximum age: 70 Years. Gender(s): Both.

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

Locations and Contacts

Additional Information

Starting date: August 2011
Last updated: January 21, 2014

Page last updated: August 23, 2015

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