Study of ME-401 in Subjects With Relapsed or Refractory Indolent B-cell Non-Hodgkin's Lymphoma

NCT03985189 | Completed Phase 1

• 1 other identifier: ME-401-K01
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 9

Brief Summary

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

Relapsed or Refractory Indolent B-cell Non-Hodgkin's Lymphoma

Outcome Measures

Primary Outcomes (1)

• Number of participants with treatment-emergent adverse events (TEAEs)

  Up to approximately 1 year

Secondary Outcomes (8)

• [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

• [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

Study Arms (1)

ME-401

EXPERIMENTAL

ME-401 administered orally

Drug: ME-401

Interventions

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.

ME-401

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \[Phase 1 study (DLT evaluation)\]
• 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.

You may not qualify if:

• \[Phase 1 study (DLT evaluation)\]
• 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.

Sponsors & Collaborators

• Kyowa Kirin Co., Ltd.: lead

Study Sites (9)

National Hospital Organization Nagoya Medical Center

Nagoya, Aichi-ken, 460-0001, Japan

Location

Japanese Red Cross Aichi Medical Center Nagoya Daini Hospital

Nagoya, Aichi-ken, 466-8650, Japan

Location

Hokkaido University Hospital

Sapporo, Hokkaido, 060-0814, Japan

Location

Tokyo Metropolitan Komagome Hospital

Bunkyo-ku, Tokyo, 113-8677, Japan

Location

National Cancer Center Hospital

Chuo-ku, Tokyo, 104-0045, Japan

Location

The Cancer Institute Hospital of JFCR

Koto-ku, Tokyo, 135-8550, Japan

Location

Aomori Prefectural Central Hospital

Aomori, 030-8553, Japan

Location

Kyushu University Hospital

Fukuoka, 812-8582, Japan

Location

Okayama University Hospital

Okayama, 700-8558, Japan

Location

Related Publications (1)

• 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.

  PMID: 36107394 DERIVED

Related Links

• 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.

MeSH Terms

Conditions

Recurrence

Interventions

ME-401

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 5, 2019
• First Posted: June 13, 2019
• Study Start: April 29, 2019
• Primary Completion: January 15, 2025
• Study Completion: January 15, 2025
• Last Updated: December 19, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

JP (9)