Clinical trial · Interventional
Study of ME-401 in Subjects With Relapsed or Refractory Indolent B-cell Non-Hodgkin's Lymphoma
A Japanese Phase 1 Study of ME-401 in Subjects With Relapsed or Refractory Indolent B-cell Non-Hodgkin's Lymphoma and Roll Over Study for Subjects Who Have Participated in ME-401-004 Study
NCT03985189CI-TRIAL-00099307completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Relapsed or Refractory Indolent B-cell Non-Hodgkin's Lymphoma | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ME-401 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- ME-401
- description
- ME-401 administered orally
- interventionNames
- Drug: ME-401
Primary outcomes (1)
- measure
- Number of participants with treatment-emergent adverse events (TEAEs)
- timeFrame
- Up to approximately 1 year
Secondary outcomes (8)
- measure
- [Phase 1 study (DLT evaluation)] Plasma concentration level of ME-401
- timeFrame
- Up to approximately 2 years
- measure
- [Phase 1 study (DLT evaluation)] Maximum plasma drug concentration (Cmax)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
Show eligibility criteria text
Inclusion Criteria: \[Phase 1 study (DLT evaluation)\] * Patients aged 20 years or older at the submission of the written informed consent form * Patients with relapsed or refractory B-cell NHL * Patients who have not undergone phosphatidylinositol 3-kinase inhibitor (PI3K) to date. * Patients who have undergone Bruton's tyrosine kinase (BTK) inhibitors and have had no exacerbation during the use of BTK inhibitors. * Patients with ECOG PS 0 or 1. Exclusion Criteria: \[Phase 1 study (DLT evaluation)\] * Patients who underwent any major surgical treatment within 4 weeks prior to the initiation of the investigational product. * Patients with poorly controlled diseases. The followings are the examples but the diseases will not be limited to those. * Patients in whom any of HBV antigen/antibody, HCV antibody, HIV antibody or HTLV-1 antibody will be positive at screening test. * Patients with active interstitial lung disease or a history thereof. * Patients who have received the investigational products other than ME-401, systemic chemotherapy or radiotherapy within 4 weeks prior to the initiation of ME-401.
References
Publications (1)
- DERIVEDGoto 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. PMID 36107394