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This is a Phase 1/2, open-label, multicenter study.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PLM60 | Experimental | Mitoxantrone Hydrochloride Liposome |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mitoxantrone Hydrochloride Liposome | Drug | Mitoxantrone Hydrochloride Liposome will be administered via IV infusion over 60 minutes once at the beginning (Day 1) of each 28-day cycle |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Tolerated Dose (MTD)(Phase 1) | 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. | 28 day cycle of therapy |
| Objective response rate (ORR; complete response + partial response [CR + PR])(Phase 2) | Tumor response and progression will be evaluated every 8 weeks according to the Lugano Classification (Cheson et al 2014). | Approximately 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum serum concentration (Cmax) of PLM60 | Approximately 1 years |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the plasma concentration-time curve (AUC) from time zero to the time point of t (AUC0-t) | Approximately 1 years | |
| Area under the plasma concentration-time curve (AUC) from time zero to infinity (AUC0-∞) | Approximately 1 years |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nashat Y Gabrail, M.D. | Contact | (330) 492-3345 |
| Name | Affiliation | Role |
|---|---|---|
| Nashat Y Gabrail, M.D. | Gabrail Cancer Center Research | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gabrail Cancer Center Research | Recruiting | Canton | Ohio | United States |
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| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| ID | Term |
|---|---|
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
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|
| Apparent terminal phase elimination rate constant (λz) | Approximately 1 years |
| Apparent terminal elimination half-life (T½β) | Approximately 1 years |
| Apparent volume of distribution (V) | Approximately 1 years |
| Total clearance (CL/F) | Approximately 1 years |
| Distribution volume (Vd/F) | Approximately 1 years |
| D008206 |
| Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |