NeoplasmsPhase 1NCT02043756

Phase I and Pharmacokinetic Study of Mitoxantrone Hydrochloride Liposome Injection

A Phase 1 study testing Mitoxantrone Hydrochloride Liposome and Mitoxantrone in people with Neoplasms, run by CSPC ZhongQi Pharmaceutical Technology Co., Ltd..

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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

Who is it for?: Ages 18 to 70 years
Conditions the study is for: Neoplasms
What is being tested?: Mitoxantrone Hydrochloride Liposome and Mitoxantrone
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 20 participants
Where: No sites listed yet
Study dates: Aug 2011to Aug 2013
Phase: Phase 1
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

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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.

Who cannot join

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

Show all 9Show fewer

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

About this study

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

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

Read the 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
Being tested: Mitoxantrone Hydrochloride Liposome, Mitoxantrone
Keywords: Mitoxantrone Hydrochloride Liposome Injection
Medical subject headings: Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Mitoxantrone Hydrochloride LiposomeDrug
Also called 2010L04017
6-16mg/m2, IV ,one time of each 28 day cycle,3 cycles
MitoxantroneDrug
Also called Novantrone
10mg/m2, IV ,on day 1 of each 28 day,3 cycles

Study groups in NCT02043756
Study group	Role	What they receive
Mitoxantrone Hydrochloride Liposome	Experimental	Dose escalation will begin at 6mg/m2 to 16mg/m2,4 weeks apart Receives: Drug: Mitoxantrone Hydrochloride Liposome
Mitoxantrone ,injection	Active comparator	When the dose of experiment drup up 10mg/m2,10mg/m2 of Mitoxantrone as active comparator Receives: Drug: Mitoxantrone

What is being measured

The primary outcome is the main question the study is designed to answer.

To determination the maximal tolerance dose and dose-limiting toxicity of Mitoxantrone Hydrochloride Liposome
Measured: 3 Weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Aug 2011Aug 2013

First posted23 Jan 2014 (estimated)
Study startAug 2011
Primary completionJun 2013
Study completionAug 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for NeoplasmsStudies of the same condition, open and under way.
More trials run by CSPC ZhongQi Pharmaceutical Technology Co., Ltd.The sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 20 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02043756
Sponsor's protocol ID: cspcmitlip
Status last verified: Jan 2014
First submitted: 16 Jan 2014
Last updated: 23 Jan 2014
Results posted: No
Data monitoring committee: No

Publications

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.
PubMed 25034977

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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All Neoplasms trials

Study at a glance

From the registry record, last updated by the sponsor on 23 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase I and Pharmacokinetic Study of Mitoxantrone Hydrochloride Liposome Injection in Patients With Solid Tumor
ClinicalTrials.gov ID: NCT02043756
Acronym / sponsor ID: cspcmitlip
Conditions: Neoplasms
Keywords: Mitoxantrone Hydrochloride Liposome Injection
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 20 participants (actual)
Lead sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd.Industry (pharma, biotech, devices)
Study start: Aug 2011
Primary completion: Jun 2013 (actual)
Study completion: Aug 2013 (actual)
First posted: 23 Jan 2014 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
Mitoxantrone Hydrochloride Liposome	Experimental	Drug: Mitoxantrone Hydrochloride LiposomeDose escalation will begin at 6mg/m2 to 16mg/m2,4 weeks apart
Mitoxantrone ,injection	Active comparator	Drug: MitoxantroneWhen the dose of experiment drup up 10mg/m2,10mg/m2 of Mitoxantrone as active comparator

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (10 listed)

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

Key exclusion criteria (9 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Mitoxantrone Hydrochloride LiposomeAlso: 2010L040176-16mg/m2, IV ,one time of each 28 day cycle,3 cycles	Drug	Mitoxantrone Hydrochloride Liposome
MitoxantroneAlso: Novantrone10mg/m2, IV ,on day 1 of each 28 day,3 cycles	Drug	Mitoxantrone ,injection

Primary outcome

To determination the maximal tolerance dose and dose-limiting toxicity of Mitoxantrone Hydrochloride Liposome
Time frame: 3 Weeks

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2014.
Derived from this study: PubMed 25034977Yang 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.

Related trials for Neoplasms

Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
RecruitingPhase 2
Tafasitamab With Acalabrutinib and Venetoclax for the Treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Chronic Lymphocytic Leukemia, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Active, not recruitingPhase 1/2
Selumetinib in Treating Young Patients With Recurrent or Refractory Low Grade Glioma
Low Grade Glioma, Recurrent Childhood Pilocytic Astrocytoma
Enrolling by invitationPhase 2
A Single-Arm Study of Nimotuzumab Combined With NALIRIFOX as First-Line Treatment for Pancreatic Cancer
Pancreatic Cancer Metastatic
Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian Cancer

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Yuankai Shi, Ph.D principal investigator

Cancer Hospital ,Chinese Academy of Mddical Sciences 010-87788701

Jianliang Yang, Ph.D study director

Cancer Hospital ,Chinese Academy of Mddical Sciences 010-87788121

Xiaohong Han, Ph.D study director

Cancer Hospital ,Chinese Academy of Mddical Sciences 010-87788701

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Mitoxantrone Hydrochloride Liposome and Mitoxantrone in people with Neoplasms, run by CSPC ZhongQi Pharmaceutical Technology Co., Ltd..

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To determination the maximal tolerance dose and dose-limiting toxicity of Mitoxantrone Hydrochloride Liposome (time frame: 3 Weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02043756, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2014.