Clinical trial NCT03985189: Study of ME-401 in Subjects With Relapsed or Refractory Indolent B-cell Non-Hodgkin's Lymphoma
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
Conditions: Relapsed or Refractory Indolent B-cell Non-Hodgkin's Lymphoma
Lead sponsor: Kyowa Kirin Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2019-06-13
Enrollment: 14
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


Eligibility criteria: 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.

Primary outcomes:
measure: Number of participants with treatment-emergent adverse events (TEAEs)
timeFrame: Up to approximately 1 year
Secondary outcomes:
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)
timeFrame: Up to approximately 2 years
measure: [Phase 1 study (DLT evaluation)] Area under the plasma drug concentration time curve (AUC)
timeFrame: Up to approximately 2 years
measure: [Phase 1 study (DLT evaluation)] Terminal half-life (t1/2)
timeFrame: Up to approximately 2 years
measure: [Phase 1 study (DLT evaluation)] Efficacy of ME-401 as assessed by the objective response rate (ORR)
timeFrame: Up to approximately 2 years
measure: [Phase 1 study (DLT evaluation)] Efficacy of ME-401 will be assessed by the duration of response (DOR)
timeFrame: Up to approximately 2 years
measure: [Phase 1 study (DLT evaluation)] Efficacy of ME-401 will be assessed by the progression-free survival (PFS)
timeFrame: Up to approximately 2 years
measure: [Phase 1 study (DLT evaluation)] Efficacy of ME-401 will be assessed by the time to response (TTR)
timeFrame: Up to approximately 2 years
Other outcomes:
Locations:
city: Nagoya
country: Japan
facility: National Hospital Organization Nagoya Medical Center
state: Aichi
city: Nagoya
country: Japan
facility: Japanese Red Cross Aichi Medical Center Nagoya Daini Hospital
state: Aichi
city: Sapporo
country: Japan
facility: Hokkaido University Hospital
state: Hokkaido
city: Bunkyo-ku
country: Japan
facility: Tokyo Metropolitan Komagome Hospital
state: Tokyo
city: Chuo-ku
country: Japan
facility: National Cancer Center Hospital
state: Tokyo
city: Koto-ku
country: Japan
facility: The Cancer Institute Hospital of JFCR
state: Tokyo
city: Aomori
country: Japan
facility: Aomori Prefectural Central Hospital
city: Fukuoka
country: Japan
facility: Kyushu University Hospital
city: Okayama
country: Japan
facility: Okayama University Hospital
Study officials:
References:
citation: 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.