TAK-659 in Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (DLBCL)

Stopped early · Phase 2

Conditions studied: Diffuse Large B-cell Lymphoma

In brief

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.

Key facts

Study ID

NCT03123393

Run by

Calithera Biosciences, Inc

People needed

49

Starts

2017-10-10

Expected to finish

2019-12-17

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…

• Must have histologically confirmed DLBCL, including de novo disease or transformed disease from indolent NHL.
• a. High-grade B-cell lymphoma (BCL) with MYC and BCL-2 and/or BCL-6 translocations (double-hit DLBCL under DLBCL, not otherwise specified [NOS], based on the 2008 World Health Organization [WHO] classification criteria) is not eligible for this study.
• Local pathology review for histological confirmation; A formalin-fixed, paraffin-embedded (FFPE) tumor block or appropriately stained slides from a fresh biopsy is required.
• Relapsed or refractory to greater than or equal to (>=) 2 prior lines of chemotherapy based on standard of care with certain requirements for prior therapy.
• Documented investigator-assessed relapse or progression after the last treatment is required if the participant responded and then progressed on the prior treatment.
• Measurable disease per IWG 2007 criteria.
• Eastern Cooperative Oncology Group (ECOG) performance status less than (<) 2.
• Life expectancy of greater than (>) 3 months.
• Adequate organ function, including the following:
• Bone marrow reserve: absolute neutrophil count (ANC) >=1000/microliter (μL), platelet count >=75,000/μL (>=50,000/μL for participants with bone marrow involvement), and hemoglobin >=8 gram per deciliter (g/dL).
• Hepatic: total bilirubin less than or equal to (<=) 1.5 times the upper limit of the normal range (ULN); alanine aminotransferase (ALT) and aspartate aminotransferase (AST) <=2.5*ULN.
• Renal: creatinine clearance >=60 milliliter per minute (mL/min).
• Others:
• Lipase <=1.5*ULN and amylase <=1.5*ULN with no clinical symptoms suggestive of pancreatitis or cholecystitis.
• Blood pressure <=Grade 1 (hypertensive participants are permitted if their blood pressure is controlled to <=Grade 1 by hypertensive medications.
• Glycosylated hemoglobin is <=6.5% hyperglycemic participants permitted if glucose is well controlled by antihyperglycemic medication).

You may not qualify if…

• Central nervous system (CNS) lymphoma; active brain or leptomeningeal metastases.
• Known human immunodeficiency virus (HIV)-related malignancy.
• Systemic anticancer treatment (including investigational agents) less than 3 weeks before the first dose of study treatment (<=4 weeks for antibody-based therapy including unconjugated antibody, antibody-drug conjugate, and bi-specific T-cell engager agents; <=8 weeks for cell-based therapy or anti-tumor vaccine).
• Radiotherapy less than 3 weeks before the first dose of study treatment. If prior radiotherapy occurred <4 to 6 weeks before study start, as radiated lesions cannot be reliably assessed by fluorodeoxyglucose-positron emission tomography (FDG-PET), nonradiated target lesions are required for eligibility, and prior radiotherapy information must be submitted to the IRC.
• Known HIV positive, hepatitis B surface antigen positive or known or suspected active hepatitis C infection.
• Prior autologous stem cell transplant (ASCT) within 6 months or prior ASCT at any time without full hematopoietic recovery before Cycle 1 Day 1, or allogeneic stem cell transplant any time.
• Participants with certain cardiovascular conditions are excluded.
• Major surgery within 14 days before the first dose of study drug or incomplete recovery from any complications from surgery.
• Systemic infection requiring parenteral antibiotic therapy or other serious infection (bacterial, fungal, or viral) within 21 days before the first dose of study drug.
• Treatment with high-dose corticosteroids for anticancer purposes within 7 days before the first dose of TAK-659.
• Participants with another malignancy within 2 years of study start. Participants with nonmelanoma skin cancer or carcinoma in situ of any type are not excluded if they have undergone complete resection and are considered disease-free at the time of study entry.
• Known gastrointestinal (GI) disease or GI procedure that could interfere with the oral absorption or tolerance of TAK-659.
• Received medications, supplements, or food/beverages that are P-glycoprotein (P-gp) inhibitors or inducers or strong cytochrome P450 (CYP) 3A inhibitors or inducers within a certain timeframe prior to the first dose of study drug. Depending on the substance, the washout period for P-gp inhibitors or inducers or strong CYP3A inhibitors or inducers will be either 7 days or 5 times the half-life (half-life is related to the time required for elimination from the body). The washout period for grapefruit containing food or beverages is 5 days.

Where it is running

• 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
• Princess Margaret Cancer Center — Toronto, Ontario, Canada
• CHU de Quebec -Universite Laval-Hopital de L'Enfant Jesus — Québec, Quebec, Canada
• Centre Hospitalier Regional de Rimouski — Rimouski, Quebec, Canada
• Hopital Haut-Leveque — Pessac, Aquitaine, France
• Centre Hospitalier Lyon Sud — Pierre-Bénite, Auvergne-Rhône-Alpes, France
• CHRU Clermont- Ferrand CHU Estaing — Clermont-Ferrand, Auvergne, France
• Centre Henri-Becquerel — Rouen, Haute-normandie, France
• Hopital Dupuytren — Limoges, Limousin, Lorraine, France
• Institut Paoli Calmettes Departement de Recherche Clinique et de l'Innovation — Marseille, Provence-Alpes-Côte d'Azur Region, France
• Hopital Necker-Enfants Malades — Paris, Île-de-France Region, France
• Hopital Saint Louis — Paris, Île-de-France Region, France
• Groupe Hospitalier - Hopitaux Universitaires Pitie-Salpetriere - Charles-Foix - Pitie-Salpetriere — Paris, Île-de-France Region, France
• Institut Gustave Roussy — Villejuif, Île-de-France Region, France
• Ospedale Casa Sollievo della Sofferenza — San Giovanni Rotondo, Foggia, Italy
• Azienda Ospedaliera Universitaria Citta della Salute e della Scienza di Torino — Turin, Piedmont, Italy

Full record on ClinicalTrials.gov

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