Phase I Study of Mitoxantrone Hydrochloride Liposome Injection

NCT02131688 | Unknown Phase 1

• 1 other identifier: CSPC-HE14Ⅰ
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine the maximum tolerated dose,the safety and effectiveness of Mitoxantrone Hydrochloride Liposome Injection.

Conditions

Malignant Lymphoma

Keywords

safety;malignant lymphoma;

Outcome Measures

Primary Outcomes (1)

• Maximum Tolerated Dose (MTD) of Mitoxantrone Hydrochloride Liposome Injection

  4 months

Secondary Outcomes (1)

• Objective Response Rate

  4 months

Study Arms (1)

Mitoxantrone Hydrochloride Liposome

EXPERIMENTAL

Drug: Mitoxantrone Hydrochloride Liposome

Interventions

Mitoxantrone Hydrochloride Liposome DRUG

Mitoxantrone Hydrochloride Liposome

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must compliance with the requirements and restrictions listed in the consent form
• Patients with Pathology and / or cytologically proven malignant lymphoma
• 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 with 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.

You may not qualify if:

• 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 tumorsMultiple 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

Sponsors & Collaborators

• CSPC ZhongQi Pharmaceutical Technology Co., Ltd.: lead

Study Sites (1)

Cancer Hospital ,Chinese Academy of Mddical Sciences

Beijing, China

RECRUITING

MeSH Terms

Conditions

Lymphoma

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Yuankai Shi, Ph.D

  Cancer Hospital ,Chinese Academy of Mddical Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 4, 2014
• First Posted: May 6, 2014
• Study Start: May 1, 2013
• Primary Completion: August 1, 2015
• Study Completion: October 1, 2015
• Last Updated: May 6, 2014

Record last verified: 2014-03

Locations

CN (1)