A Phase 1b Study of TAK-659 in Combination With Venetoclax for Adult Patients With Previously Treated Non-Hodgkin Lymphoma

Status
Active
Cancer Type
Lymphoma
Trial Phase
Phase I
Eligibility
18 Years and older, Male and Female
Study Type
Other
NCD ID
NCT03357627
Protocol IDs
C34008 (primary)
NCI-2018-00464
2017-002872-14
U1111-1203-9951
Study Sponsor
Millennium Pharmaceuticals, Inc.

Summary

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.

Objectives

The drug being tested in this study is called TAK-659. TAK-659 in combination with venetoclax is being tested to treat people who have advanced NHL after at least 1 prior line of therapy. This study will look at the safety data, pharmacokinetic (PK) data and any early anti tumor activity observed. The study will enroll approximately 53 participants. • TAK-659 and venetoclax doses will be escalated according to a Bayesian logistic regression model (BLRM) with overdose control escalation schema. TAK-659 60 mg + Venetoclax 400 mg is the starting dose. Participants could also receive 20 mg, 40 mg, 80 mg or 100 mg TAK-659 during dose escalation. Following dose escalation the safety and tolerability of the MTD/RP2D of the TAK-659+venetoclax combination will be further explored in two dose-safety expansion cohorts, Cohort 1 in participants with DLBCL and Cohort 2 in participants with FL. All participants will be asked to take one tablet of TAK-659 on an empty stomach at least 1 hour before and no sooner than 2 hours after eating food and/or drinking fluids other than water. Venetoclax will be taken with a meal and water 2 hours after TAK-659 has been taken. No food or drink (except water) are allowed between TAK-659 and venetoclax. TAK-659 and venetoclax should be taken at the same time each day throughout the study. This multi-center trial will be conducted in the United States, Canada and Europe. The overall time to participate in this study is 6 months or until disease progression, unacceptable toxicities, or withdrawal from study by participant. Participants will make multiple visits to the clinic, and will be followed for 28 days (+10) days after the last dose of TAK-659 or venetoclax or the start of subsequent alternative anticancer therapy to permit the detection of any delayed treatment-related AEs. For participants enrolled in either the dose escalation or safety expansion phases, the maximum duration of treatment will be 12 months unless, in the opinion of the investigator and with the agreement of the sponsor, the participant would derive benefit from continued therapy beyond 12 months. Participants enrolled in the safety expansion part who stop treatment for any reason other than disease progression (PD) will continue progression free survival (PFS) follow-up every 2 months after the last dose of study drug for up to 6 months or until PD or the start of alternative therapy, whichever occurs first.