A Study of TAK-659 in Combination With Venetoclax for Adult Participants With Previously Treated Non-Hodgkin Lymphoma

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Calithera Biosciences, Inc
Study ID
NCT03357627
Phase
PHASE1
Status
Completed

Conditions

  • Lymphoma, Follicular
  • Lymphoma, Large B-cell, Diffuse
  • Lymphoma, Non-Hodgkin

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • TAK-659 — DRUG
    TAK-659 tablets.
  • Venetoclax — DRUG
    Venetoclax tablets.

Study Details

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.

Key Dates

Start date
Feb 16, 2018
Status verified
Feb 2023
Primary completion
Aug 3, 2021
Completion
Aug 3, 2021

Study Design

Enrollment
43 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
OTHER

Arms

  • Experimental: Dose Escalation: TAK-659 + Venetoclax
    TAK-659 40, 60, 80, or 100 milligram (mg) (tablet, orally, once daily, up to 35 days in Cycle 1 or in different intermittent schedules \[7 days dosing followed by 7 days off or 14 days dosing followed by 7 days off or other intermittent dosing schedules\]) along with venetoclax 200, 400, 800 or 1200 mg (tablet, orally, once daily, up to 35 days in Cycle 1). After Cycle 1, TAK-659 and venetoclax will be administered once daily in a 28-day treatment cycle until disease progression, unacceptable toxicities, or discontinuation by participant.
  • Experimental: Safety Expansion: Diffuse Large B-cell Lymphoma (DLBCL) Cohort
    TAK-659 tablet, orally, once daily along with venetoclax tablet, orally, once daily in a 28-day treatment cycle until disease progression, unacceptable toxicities, or discontinuation by participant. TAK-659 and venetoclax MTD/RP2D will be determined from the dose escalation phase.
  • Experimental: Safety Expansion: Follicular Lymphoma (FL) Cohort
    TAK-659 tablet, orally, once daily along with venetoclax tablet, orally, once daily in a 28-day treatment cycle until disease progression, unacceptable toxicities, or discontinuation by participant. TAK-659 and venetoclax MTD/RP2D will be determined from the dose escalation phase.

Primary Outcome Measure

Number of Participants with a Dose Limiting Toxicity (DLT) [ Time Frame: Baseline up to 5 weeks ]

Locations (8)

FacilityCityStateZIPSite coordinators
University of Alabama at BirminghamBirminghamAlabama35249-
Emory UniversityAtlantaGeorgia30322-
NorthShore Medical Group - EvanstonEvanstonIllinois60201-
Ingalls Memorial HospitalHarveyIllinois60426-
Norton Cancer Institute - ShelbyvilleShelbyvilleKentucky40065-
Dana Farber Cancer InstituteBostonMassachusetts02215-
Icahn School of Medicine at Mount SinaiNew YorkNew York10029-
Baylor Scott & White Research InstituteDallasTexas75246-

Find similar trials in Birmingham, AL

By research site
University of Alabama at Birmingham· Birmingham, ALEmory University· Atlanta, GANorthShore Medical Group - Evanston· Evanston, ILIngalls Memorial Hospital· Harvey, ILNorton Cancer Institute - Shelbyville· Shelbyville, KYDana Farber Cancer Institute· Boston, MA

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