The purpose of this study is to determine the maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D) of TAK-659 and venetoclax when administered in combination in participants with non-Hodgkin lymphoma (NHL) relapsed and/or refractory after at least 1 prior line of therapy and to evaluate safety and tolerability of TAK-659 and venetoclax when administered in combination.
Name: TAK-659
Description: TAK-659 tablets.Type: DrugDose Escalation: TAK-659 + Venetoclax Safety Expansion: Diffuse Large B-cell Lymphoma (DLBCL) Cohort Safety Expansion: Follicular Lymphoma (FL) Cohort
Name: Venetoclax
Description: Venetoclax tablets.Type: DrugDose Escalation: TAK-659 + Venetoclax Safety Expansion: Diffuse Large B-cell Lymphoma (DLBCL) Cohort Safety Expansion: Follicular Lymphoma (FL) Cohort
Description: Toxicity will be evaluated according to National Cancer Institute Common Terminology Criteria for Adverse Event (NCI CTCAE), Version 5.0 DLT will be defined as any of the events specified in the protocol that are considered by the investigator to be at least possibly related to therapy with study medications and that occur within the first cycle.
Measure: Number of Participants with a Dose Limiting Toxicity (DLT) Time: Baseline up to 5 weeksDescription: AE Grades will be evaluated as per NCI CTCAE, version 5.0.
Measure: Percentage of Participants Reporting one or More Treatment-emergent Adverse Events (TEAEs), Grade 3 or Higher Adverse Events (AEs), Serious Adverse Events (SAEs) and AEs Leading to Discontinuation Time: Baseline up to 13 monthsDescription: ORR is calculated as percentage of participants with complete response (CR) + percentage of participants with partial response (PR) as assessed by International Working Group (IWG) criteria for malignant lymphoma.
Measure: Overall Response Rate (ORR) Time: Up to 12 monthsDescription: CR rate is calculated as percentage of participants with CR as assessed by IWG criteria for malignant lymphoma.
Measure: CR Rate Time: Up to 12 monthsDescription: TTP will be measured as the time in months from the first dose of study treatment to the date of the first documented disease progression as assessed using IWG criteria.
Measure: Time to Progression (TTP) Time: Up to 13 monthsDescription: PFS is defined as the time from date of first study drug administration to the day of first documented disease progression or death due to any cause, whichever occurs first.
Measure: Progression-free Survival (PFS) Time: Up to 18 monthsAllocation: Non-Randomized
Sequential Assignment
There is one SNP
Use or consumption of: - Medications or supplements that are known to be strong or moderate Cytochrome P4503A (CYP3A) inhibitors or strong or moderate CYP3A inducers and/or P-glycoprotein (P-gp) inhibitors or inducers within 7 days or within 5 times the inhibitor or inducer half-life (whichever is longer) before the first dose of study drugs. --- P4503A ---