NCT02043756

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Aug 2011

Typical duration for phase_1

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2011

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2013

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

January 16, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 23, 2014

Completed
Last Updated

January 23, 2014

Status Verified

January 1, 2014

Enrollment Period

1.8 years

First QC Date

January 16, 2014

Last Update Submit

January 21, 2014

Conditions

Neoplasms

Keywords

Mitoxantrone Hydrochloride Liposome Injection

Outcome Measures

Primary Outcomes (1)

  • To determination the maximal tolerance dose and dose-limiting toxicity of Mitoxantrone Hydrochloride Liposome

    3 Weeks

Study Arms (2)

Mitoxantrone Hydrochloride Liposome

EXPERIMENTAL

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

Drug: Mitoxantrone Hydrochloride Liposome

Mitoxantrone ,injection

ACTIVE COMPARATOR

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

Drug: Mitoxantrone

Interventions

Mitoxantrone Hydrochloride LiposomeDRUG

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

Also known as: 2010L04017
Mitoxantrone Hydrochloride Liposome
MitoxantroneDRUG

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

Also known as: Novantrone
Mitoxantrone ,injection

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (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 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.

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 tumors

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 25034977DERIVED

MeSH Terms

Conditions

Neoplasms

Interventions

Mitoxantrone

Intervention Hierarchy (Ancestors)

AnthraquinonesAnthronesAnthracenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsQuinonesPolycyclic Compounds

Study Officials

  • Yuankai Shi, Ph.D

    Cancer Hospital ,Chinese Academy of Mddical Sciences 010-87788701

    PRINCIPAL INVESTIGATOR

  • Jianliang Yang, Ph.D

    Cancer Hospital ,Chinese Academy of Mddical Sciences 010-87788121

    STUDY DIRECTOR

  • Xiaohong Han, Ph.D

    Cancer Hospital ,Chinese Academy of Mddical Sciences 010-87788701

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 16, 2014

First Posted

January 23, 2014

Study Start

August 1, 2011

Primary Completion

June 1, 2013

Study Completion

August 1, 2013

Last Updated

January 23, 2014

Record last verified: 2014-01