The purpose of this study is to assess the efficacy of TAK-659 measured by independent radiologic review committee (IRC)-assessed overall response rate (ORR) in participants with relapsed or refractory DLBCL.
The drug being tested is TAK-659. This study will evaluate overall response rate (ORR) in participants with relapsed or refractory DLBCL who take TAK-659. The study will enroll approximately 122 participants. Participants will be assigned to: • TAK-659 60 mg to 100 mg All participants will be asked to take the tablets of TAK-659 at the same time each day throughout the study in a 28-day cycle. This multi-center trial will be conducted in the United States, United Kingdom, Spain, Italy, France, Canada, Germany. The overall time to participate in this study is approximately 48 months. Participants will be assessed for disease response and progression during the PFS follow-up every 3 months after end of treatment (for participants who discontinue due to reasons other than disease progression) and OS follow-up every 3 months from the last dose of study drug until death or conclusion of the study, whichever occurs first.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
49
TAK-659 Tablets
Stage 2: ORR as Assessed by Independent Radiologic Review Committee (IRRC) Based on Modified 2007 International Working Group (IWG) Criteria
ORR was defined as the percentage of participants with complete response (CR), or partial response (PR) as assessed by IRRC according to the modified 2007 IWG criteria for malignant lymphoma. CR was defined as disappearance of all evidence of disease. PR was defined as regression of measurable disease and no new sites.
Time frame: Up to 12 months
Stage 2: CR Rate as Assessed by IRC Based on Modified 2007 IWG Criteria
CR rate was defined as percentage of participants with complete response as assessed by IRC according to the modified 2007 IWG. CR was defined as disappearance of all evidence of disease.
Time frame: Up to 12 months
Stage 2: ORR as Assessed by IRRC Based on 2014 IWG-Lugano Criteria
ORR was defined as the percentage of participants with CR or PR as assessed by IRRC according to the 2014 Lugano classification, IWG criteria for malignant lymphoma. CR was defined as disappearance of all evidence of disease. PR was defined as regression of measurable disease and no new sites.
Time frame: Up to 12 months
Stage 2: CR Rate as Assessed by IRRC Based on 2014 IWG-Lugano Criteria
CR rate was defined as percentage of participants with complete response as assessed by IRC according to the 2014 Lugano classification, IWG criteria. CR was defined as disappearance of all evidence of disease.
Time frame: Up to 12 months
Stage 2: Duration of Response (DOR)
DOR was defined as the time from the date of first documentation of a CR/PR to the date of first documentation of tumor progression or progressive disease (PD) per IRRC assessment according to IWG criteria. CR was defined as disappearance of all evidence of disease. PR was defined as regression of measurable disease and no new sites. PD was defined as presence of any new lesion or increase by \>=50% of previously involved sites from nadir.
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University of Kansas Medical Center
Westwood, Kansas, United States
University of Michigan
Ann Arbor, Michigan, United States
Roswell Park Cancer Institute
Buffalo, New York, United States
New York University Langone Medical Center
New York, New York, United States
Perelman Center for Advanced Medicine
Philadelphia, Pennsylvania, United States
Swedish Medical Oncology - Edmonds
Edmonds, Washington, United States
Swedish Cancer Institute - Issaquah
Issaquah, Washington, United States
Swedish Health Services
Seattle, Washington, United States
University of Washington, Hutchinson Cancer Research Center
Seattle, Washington, United States
Swedish First Hill Campus
Seattle, Washington, United States
...and 31 more locations
Time frame: Up to 12 months
Stage 2: Duration of CR
Duration of CR was defined as the time from the date of first documentation of a CR/PR to the date of first documentation of tumor progression or PD per IRRC assessment according to IWG criteria. CR was defined as disappearance of all evidence of disease. PR was defined as regression of measurable disease and no new sites. PD was defined as presence of any new lesion or increase by \>=50% of previously involved sites from nadir.
Time frame: Up to 12 months
Stage 2: ORR as Assessed by IRRC in Participants With Germinal Center B-cell (GCB) DLBCL
ORR was defined as the percentage of participants with CR or PR as assessed by IRRC according to the modified 2007 IWG criteria for malignant lymphoma. CR was defined as disappearance of all evidence of disease. PR was defined as regression of measurable disease and no new sites.
Time frame: Up to 12 months
Stage 2: ORR as Assessed by IRC in Participants With DLBCL Transformed From Indolent Non-Hodgkin's Lymphoma (NHL)
ORR was defined as the percentage of participants with CR or PR as assessed by IRC according to the modified 2007 IWG criteria for malignant lymphoma. CR was defined as disappearance of all evidence of disease. PR was defined as regression of measurable disease and no new sites.
Time frame: Up to 12 months
Stage 2: Progression Free Survival (PFS) as Assessed by IRC
PFS was defined as time from start of study treatment to first documentation of PD per IRC assessment or up to death due to any cause, whichever occurs first based on IWG criteria. PD was defined as presence of any new lesion or increase by \>=50% of previously involved sites from nadir.
Time frame: Up to 18 months
Stage 2: Overall Survival (OS)
OS was defined as the time from start of study treatment to date of death due to any cause.
Time frame: Up to 24 months
Stage 1: ORR as Assessed by IRRC to Select Stage 2 Dose Regimen of TAK-659 From the Lead-in Dose Exploration Phase
ORR was defined as the percentage of participants with CR or PR as assessed by IRC. CR was defined as disappearance of all evidence of disease. PR was defined as regression of measurable disease and no new sites.
Time frame: Up to 12 months
Stage 2: ORR as Assessed by IRC at 3, 6, and 9 Cycles in Participants With DLBCL
ORR was defined as the percentage of participants with CR or PR as assessed by IRC according to the modified 2007 IWG criteria for malignant lymphoma. CR was defined as disappearance of all evidence of disease. PR was defined as regression of measurable disease and no new sites.
Time frame: At Cycles 3, 6 and 9 (Up to 12 months) (Each cycle of 28 days)