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

Completed · Phase 1

Conditions studied: Lymphoma, Non-Hodgkin, Lymphoma, Large B-cell, Diffuse, Lymphoma, Follicular

In brief

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 facts

Study ID

NCT03357627

Run by

Calithera Biosciences, Inc

People needed

43

Starts

2018-02-16

Expected to finish

2021-08-03

Last updated by the study team

2023-02-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• For the Dose Escalation phase, participants must have histologically confirmed diagnosis of advanced NHL of any histology (with the exception of participants with mantle cell lymphoma [MCL] or chronic lymphoma leukemia [CLL]).
• For the Safety Expansion phase, participants must have histologically confirmed diagnosis of advanced DLBCL or FL.
• Radiographically or clinically measurable disease with greater than or equal to (>=) 1 target lesion per IWG criteria for malignant lymphoma.
• Refractory or relapsed after at least 1 prior line of therapy for whom no effective standard therapy is available per investigator's assessment.
• o Participants who are either treatment-naive to, relapsed after, or refractory to ibrutinib, idelalisib, or any other investigational B cell receptor (BCR) pathway inhibitors not directly targeting spleen tyrosine kinase (SYK) are allowed.
• Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
• Life expectancy of greater than 3 months.
• Suitable venous access for the study-required blood sampling that is, including PK and pharmacodynamic sampling.
• Recovered (that is, less than or equal to [<=] Grade 1 toxicity) from the reversible effects of prior anticancer therapy.

You may not qualify if…

• Central nervous system (CNS) lymphoma; active brain or leptomeningeal metastases, as indicated by positive cytology from lumbar puncture or computed tomography (CT) scan/magnetic resonance imaging (MRI).
• History of drug-induced pneumonitis requiring treatment with steroids; history of idiopathic pulmonary fibrosis, organizing pneumonia, or evidence of active pneumonitis on screening chest CT scan; history of radiation pneumonitis in the radiation field (fibrosis) is permitted.
• Participants requires the use of warfarin (use in prophylactic doses [example, deep vein thrombosis prophylaxis]) is allowed.
• Prior exposure to targeted SYK inhibitors.
• History of a prior intolerable toxicity, in the opinion of the investigator from another B-cell lymphoma (BCL)-2 family protein inhibitor study.
• Participants who are relapsed after or refractory to regimens containing venetoclax or other BCL2 inhibitors.
• Systemic anticancer treatment (including investigational agents) or radiotherapy less than 2 weeks before the first dose of study treatment (<=4 weeks for large molecule agents; <=8 weeks for cell-based therapy or anti-tumor vaccine), or not recovered from the reversible effects of prior anticancer therapy.
• Prior autologous stem cell transplant (ASCT) within 6 months preceding Cycle 1 Day 1.
• Prior allogeneic stem cell transplant and/or chimeric antigen receptor T-cell therapy at any time.
• Major surgery within 14 days before the first dose of study drug and not recovered fully from any complications from surgery.
• Known human immunodeficiency virus (HIV) positive or HIV-related malignancy.
• Received a live viral vaccine within 6 months prior to the first dose of study drug.
• 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. In general, the use of these agents is not permitted during the study except in cases in which an adverse event (AE) must be managed during interruption of study drug dosing.
• Food or beverages containing grapefruit, Seville oranges, or Star fruit within 5 days before the first dose of study drugs. Note that food and beverages containing grapefruit, Seville orange, or Star fruit are not permitted during the study.
• Preparations containing St. John's wort within 7 days before the first dose of study drugs. Note that preparations containing St. John's wort are not permitted during the study.

Where it is running

• University of Alabama at Birmingham — Birmingham, Alabama, United States
• Emory University — Atlanta, Georgia, United States
• NorthShore Medical Group - Evanston — Evanston, Illinois, United States
• Ingalls Memorial Hospital — Harvey, Illinois, United States
• Norton Cancer Institute - Shelbyville — Shelbyville, Kentucky, United States
• Dana Farber Cancer Institute — Boston, Massachusetts, United States
• Icahn School of Medicine at Mount Sinai — New York, New York, United States
• Baylor Scott & White Research Institute — Dallas, Texas, United States
• Hopital Maisonneuve-Rosemont — Montreal, Quebec, Canada
• Jewish General Hospital — Montreal, Quebec, Canada
• Universitatsklinikum Heidelberg — Heidelberg, Baden-Wurttemberg, Germany
• Universitatsklinikum Ulm — Ulm, Baden-Wurttemberg, Germany
• Universitatklinikum der Ludwig-Maximilians-Universitat Munchen — München, Bavaria, Germany
• Universitatsklinikum Frankfurt — Frankfurt am Main, Hesse, Germany
• Universitatsmedizin der Johannes Gutenberg Universitat — Mainz, Rhineland-Palatinate, Germany

Full record on ClinicalTrials.gov

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