Spots Global Cancer Trial Database for A Study of Mitoxantrone Hydrochloride Liposome Infusion
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Trial Identification
Brief Title: A Study of Mitoxantrone Hydrochloride Liposome Infusion
Official Title: A Phase 1/2 Study of Mitoxantrone Hydrochloride Liposome Infusion in Patients With Non-Hodgkin's Lymphoma
Study ID: NCT02856685
Conditions
Interventions
Study Description
Brief Summary: This is a Phase 1/2, open-label, multicenter study.
Detailed Description: The Phase 1 part of this study is designed to identify the MTD and RP2D, and to characterize the safety, tolerability, and PK. The Phase 1 part of the study will include 2 parts: dose escalation and dose expansion. After confirmation of the RP2D in the expansion part of Phase 1, enrolment into the Phase 2 part of the study will begin. The primary objective of the Phase 2 part of the study is to evaluate the efficacy of the investigational drug when administered to patients with relapsed or refractory NHL.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Gabrail Cancer Center Research, Canton, Ohio, United States
Contact Details
Name: Nashat Y Gabrail, M.D.
Affiliation: Gabrail Cancer Center Research
Role: PRINCIPAL_INVESTIGATOR
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