Clinical trial · Interventional
Phase I and Pharmacokinetic Study of Mitoxantrone Hydrochloride Liposome Injection
Phase I and Pharmacokinetic Study of Mitoxantrone Hydrochloride Liposome Injection in Patients With Solid Tumor
NCT02043756CI-TRIAL-00013542completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of the study is to examine the toxicity profile, maximum tolerated dose (MTD), and pharmacokinetics of Mitoxantrone Hydrochloride Liposome Injection.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Neoplasms | Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Mitoxantrone | Drug | Mitoxantrone | ALIAS |
| Mitoxantrone Hydrochloride Liposome | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Mitoxantrone Hydrochloride Liposome
- description
- Dose escalation will begin at 6mg/m2 to 16mg/m2,4 weeks apart
- interventionNames
- Drug: Mitoxantrone Hydrochloride Liposome
- type
- ACTIVE_COMPARATOR
- label
- Mitoxantrone ,injection
- description
- When the dose of experiment drup up 10mg/m2,10mg/m2 of Mitoxantrone as active comparator
- interventionNames
- Drug: Mitoxantrone
Primary outcomes (1)
- measure
- To determination the maximal tolerance dose and dose-limiting toxicity of Mitoxantrone Hydrochloride Liposome
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDYang 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 25034977