Spots Global Cancer Trial Database for A Study of Mitoxantrone Hydrochloride Liposome Injection in the Treatment of Advanced Solid Tumor
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Trial Identification
Brief Title: A Study of Mitoxantrone Hydrochloride Liposome Injection in the Treatment of Advanced Solid Tumor
Official Title: A Multicenter, Randomized, Open-label, Phase Ib Study to Evaluate the Safety, Efficacy and Pharmacokinetic Characteristics of Mitoxantrone Hydrochloride Liposome Injection in Subjects With Advanced Solid Tumor
Study ID: NCT04719065
Conditions
Study Description
Brief Summary: This is a multicenter, randomized, open-label, phase Ib study to evaluate the safety, efficacy and pharmacokinetic characteristics of Mitoxantrone Hydrochloride Liposome in subjects with advanced solid tumor.
Detailed Description: This is a multicenter, randomized, open-label, phase Ib study to evaluate the safety, efficacy and pharmacokinetic characteristics of Mitoxantrone Hydrochloride Liposome in subjects with advanced solid tumor. 90 subjects will be recruited. The first 60 subjects will be randomly assigned into 2 groups, group A and group B. The 30 subjects in group A will receive the Mitoxantrone Hydrochloride Liposome 20 mg/m2 by an intravenous infusion (IV), every 28 days (q4w, 1 cycle). The 30 subjects in group B will receive Mitoxantrone Hydrochloride Liposome 20 mg/m2, IV, every 21 days (q3w, 1 cycle). After this, the last 30 subjects will be assigned into group B. All subjects will receive the treatment until disease progression, intolerable toxic reaction, death, or withdrawal by investigator or subject decision (a maximum of 8 cycles). Delays in drug administration is allowed from cycle 2, however, the delays should be no more than 3 weeks. Dose adjustments after cycle 2 is permitted, and the minimum dose is 12 mg/m2.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
The First Affiliated Hospital of Bengbu Medical College, Bengbu, Anhui, China
Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University, Guangzhou, Guangdong, China
The Affiliated Cancer Hospital of Guizhou Medical University, Guiyang, Guizhou, China
Affiliated Hospital of Hebei University, Baoding, Hebei, China
Renmin Hospital of Wuhan University, Wuhan, Hubei, China
Fudan University Shanghai Cancer Center, Shanghai, Shanghai, China
Yibin Second People's Hospital, Yibin, Sichuan, China
Tianjin Medical University Cancer Institute & Hospital, Tianjin, Tianjin, China
Contact Details
Name: Yehui Shi, MD
Affiliation: Tianjin Medical University Cancer Institute & Hospital
Role: PRINCIPAL_INVESTIGATOR
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