A Study of Mitoxantrone Hydrochloride Liposome Infusion
|Non-Hodgkin's Lymphoma||Drug: Mitoxantrone Hydrochloride Liposome||Phase 1 Phase 2|
|Study Design:||Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||A Phase 1/2 Study of Mitoxantrone Hydrochloride Liposome Infusion in Patients With Non-Hodgkin's Lymphoma|
- Maximum Tolerated Dose (MTD)(Phase 1) [ Time Frame: 28 day cycle of therapy ]Phase 1 -MTD defined as the highest dose level in which 6 patients have been treated with less than 2 instances of dose limiting toxicity (DLT). Dose limiting toxicity is based on adverse events and includes unacceptable hematologic toxicity, unacceptable non-hematologic toxicity, and laboratory abnormalities of Grade 4 or higher.
- Objective response rate (ORR; complete response + partial response [CR + PR])(Phase 2) [ Time Frame: Approximately 2 years ]Tumor response and progression will be evaluated every 8 weeks according to the Lugano Classification (Cheson et al 2014).
- Maximum serum concentration (Cmax) of PLM60 [ Time Frame: Approximately 1 years ]
- Area under the plasma concentration-time curve (AUC) from time zero to the time point of t (AUC0-t) [ Time Frame: Approximately 1 years ]
- Area under the plasma concentration-time curve (AUC) from time zero to infinity (AUC0-∞) [ Time Frame: Approximately 1 years ]
- Apparent terminal phase elimination rate constant (λz) [ Time Frame: Approximately 1 years ]
- Apparent terminal elimination half-life (T½β) [ Time Frame: Approximately 1 years ]
- Apparent volume of distribution (V) [ Time Frame: Approximately 1 years ]
- Total clearance (CL/F) [ Time Frame: Approximately 1 years ]
- Distribution volume (Vd/F) [ Time Frame: Approximately 1 years ]
|Study Start Date:||August 2016|
|Estimated Study Completion Date:||May 2018|
|Estimated Primary Completion Date:||July 2017 (Final data collection date for primary outcome measure)|
Mitoxantrone Hydrochloride Liposome
Drug: Mitoxantrone Hydrochloride Liposome
Mitoxantrone Hydrochloride Liposome will be administered via IV infusion over 60 minutes once at the beginning (Day 1) of each 28-day cycle
Other Name: PLM60
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02856685
|Contact: Nashat Y Gabrail, M.D.||(330) 492-3345|
|United States, Ohio|
|Gabrail Cancer Center Research||Recruiting|
|Canton, Ohio, United States|
|Contact: Nashat Y Gabrail, MD|
|Principal Investigator:||Nashat Y Gabrail, M.D.||Gabrail Cancer Center Research|