Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of ME-401 in the treatment of Japanese participants with Relapsed or Refractory indolent B-Cell Non-Hodgkin's Lymphoma and to continue administraion of ME-401 to patients with relapsed or refractory B-cell NHL with collecting safety information
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ME-401 | Experimental | ME-401 administered orally |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ME-401 | Drug | [Phase 1 study (DLT evaluation)] ME-401 will be administered at 2 dosages as 45 mg (Cohort 1) or 60 mg (Cohort 2), daily oral administration, QD, and the trial will be initiated at Cohort 1, and medical specialists and the Efficacy and Safety Assessment Committee as needed will decide whether the Cohort will be shifted to the next stage based on their assessment of the safety and tolerability. [Roll over study] 60 mg ME-401 will be administrated on intermittent schedule (1 week on and 3 week off in every 4-week cycle)and will continue until the prescribed mediation in ME-401-004 study is completed or discontinuation criteria are met. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with treatment-emergent adverse events (TEAEs) | Up to approximately 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| [Phase 1 study (DLT evaluation)] Plasma concentration level of ME-401 | Up to approximately 2 years | |
| [Phase 1 study (DLT evaluation)] Maximum plasma drug concentration (Cmax) | Up to approximately 2 years |
Not provided
Inclusion Criteria:
[Phase 1 study (DLT evaluation)]
Exclusion Criteria:
[Phase 1 study (DLT evaluation)]
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Hospital Organization Nagoya Medical Center | Nagoya | Aichi-ken | 460-0001 | Japan | ||
| Japanese Red Cross Aichi Medical Center Nagoya Daini Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36107394 | Derived | Goto H, Izutsu K, Ennishi D, Mishima Y, Makita S, Kato K, Hanaya M, Hirano S, Narushima K, Teshima T, Nagai H, Ishizawa K. Zandelisib (ME-401) in Japanese patients with relapsed or refractory indolent non-Hodgkin's lymphoma: an open-label, multicenter, dose-escalation phase 1 study. Int J Hematol. 2022 Dec;116(6):911-921. doi: 10.1007/s12185-022-03450-5. Epub 2022 Sep 15. |
| Label | URL |
|---|---|
| Goto H, Izutsu K, Ennishi D, et al. Zandelisib (ME-401) in Japanese patients with relapsed or refractory indolent non-Hodgkin's lymphoma: an open-label, multicenter, dose-escalation phase 1 study. Int J Hematol. 2022 Dec;116(6):911-921. | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D012008 | Recurrence |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| C000654193 | ME-401 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| [Phase 1 study (DLT evaluation)] Area under the plasma drug concentration time curve (AUC) | Up to approximately 2 years |
| [Phase 1 study (DLT evaluation)] Terminal half-life (t1/2) | Up to approximately 2 years |
| [Phase 1 study (DLT evaluation)] Efficacy of ME-401 as assessed by the objective response rate (ORR) | Up to approximately 2 years |
| [Phase 1 study (DLT evaluation)] Efficacy of ME-401 will be assessed by the duration of response (DOR) | Up to approximately 2 years |
| [Phase 1 study (DLT evaluation)] Efficacy of ME-401 will be assessed by the progression-free survival (PFS) | Up to approximately 2 years |
| [Phase 1 study (DLT evaluation)] Efficacy of ME-401 will be assessed by the time to response (TTR) | Up to approximately 2 years |
| Nagoya |
| Aichi-ken |
| 466-8650 |
| Japan |
| Hokkaido University Hospital | Sapporo | Hokkaido | 060-0814 | Japan |
| Tokyo Metropolitan Komagome Hospital | Bunkyo-ku | Tokyo | 113-8677 | Japan |
| National Cancer Center Hospital | Chuo-ku | Tokyo | 104-0045 | Japan |
| The Cancer Institute Hospital of JFCR | Koto-ku | Tokyo | 135-8550 | Japan |
| Aomori Prefectural Central Hospital | Aomori | 030-8553 | Japan |
| Kyushu University Hospital | Fukuoka | 812-8582 | Japan |
| Okayama University Hospital | Okayama | 700-8558 | Japan |