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

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

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03985189
• Other study ID #: ME-401-K01
• Status: Active, not recruiting
• Phase: Phase 1
• Start date: April 29, 2019
• Est. completion date: September 30, 2024

Study information

• Verified date: April 2023
• Source: Kyowa Kirin Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 14
• Est. completion date: September 30, 2024
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

Drug:
• ME-401
[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.

Locations

Country	Name	City	State
Japan	Aomori Prefectural Central Hospital	Aomori
Japan	Tokyo Metropolitan Komagome Hospital	Bunkyo-ku	Tokyo
Japan	National Cancer Center Hospital	Chuo-ku	Tokyo
Japan	Kyushu University Hospital	Fukuoka
Japan	The Cancer Institute Hospital of JFCR	Koto-ku	Tokyo
Japan	Japanese Red Cross Aichi Medical Center Nagoya Daini Hospital	Nagoya	Aichi
Japan	National Hospital Organization Nagoya Medical Center	Nagoya	Aichi
Japan	Okayama University Hospital	Okayama
Japan	Hokkaido University Hospital	Sapporo	Hokkaido

Sponsors (1)

Lead Sponsor	Collaborator
Kyowa Kirin Co., Ltd.

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with treatment-emergent adverse events (TEAEs)		Up to approximately 1 year
Secondary	[Phase 1 study (DLT evaluation)] Plasma concentration level of ME-401		Up to approximately 2 years
Secondary	[Phase 1 study (DLT evaluation)] Maximum plasma drug concentration (Cmax)		Up to approximately 2 years
Secondary	[Phase 1 study (DLT evaluation)] Area under the plasma drug concentration time curve (AUC)		Up to approximately 2 years
Secondary	[Phase 1 study (DLT evaluation)] Terminal half-life (t1/2)		Up to approximately 2 years
Secondary	[Phase 1 study (DLT evaluation)] Efficacy of ME-401 as assessed by the objective response rate (ORR)		Up to approximately 2 years
Secondary	[Phase 1 study (DLT evaluation)] Efficacy of ME-401 will be assessed by the duration of response (DOR)		Up to approximately 2 years
Secondary	[Phase 1 study (DLT evaluation)] Efficacy of ME-401 will be assessed by the progression-free survival (PFS)		Up to approximately 2 years
Secondary	[Phase 1 study (DLT evaluation)] Efficacy of ME-401 will be assessed by the time to response (TTR)		Up to approximately 2 years

External 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.