Study of ME-401 in Subjects With Relapsed or Refractory Indolent B-cell Non-Hodgkin's Lymphoma (NCT03985189) | Clinical Trial Compass
CompletedPhase 1
Study of ME-401 in Subjects With Relapsed or Refractory Indolent B-cell Non-Hodgkin's Lymphoma
Japan14 participantsStarted 2019-04-29
Plain-language 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
Who can participate
Age range20 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
What they're measuring
1
Number of participants with treatment-emergent adverse events (TEAEs)