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

6 de febrero de 2023 actualizado por: Calithera Biosciences, Inc

Phase 2 Study of TAK-659 in Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma After at Least 2 Prior Lines of Chemotherapy

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.

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Descripción detallada

The drug being tested is TAK-659. This study will evaluate overall response rate (ORR) in participants with relapsed or refractory DLBCL who take TAK-659.

The study will enroll approximately 122 participants. Participants will be assigned to:

• TAK-659 60 mg to 100 mg

All participants will be asked to take the tablets of TAK-659 at the same time each day throughout the study in a 28-day cycle.

This multi-center trial will be conducted in the United States, United Kingdom, Spain, Italy, France, Canada, Germany. The overall time to participate in this study is approximately 48 months. Participants will be assessed for disease response and progression during the PFS follow-up every 3 months after end of treatment (for participants who discontinue due to reasons other than disease progression) and OS follow-up every 3 months from the last dose of study drug until death or conclusion of the study, whichever occurs first.

Tipo de estudio

Intervencionista

Inscripción (Actual)

49

Fase

  • Fase 2

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

  • Canadá
      • Quebec, Canadá, G1J 1Z4
        • CHU de Quebec -Universite Laval-Hopital de L'Enfant Jesus
    • Ontario
      • Toronto, Ontario, Canadá, M5G2M9
        • Princess Margaret Cancer Center
    • Quebec
      • Rimouski, Quebec, Canadá, G5L 5T1
        • Centre Hospitalier Regional De Rimouski
  • España
      • Barcelona, España, 08036
        • Hospital Clínic de Barcelona
      • Barcelona, España, 08035
        • Hospital Universitari Vall d'Hebron
      • Madrid, España, 28046
        • Hospital Universitario La Paz
      • Madrid, España, 28009
        • Hospital General Universitario Gregorio Marañon
      • Salamanca, España, 37007
        • Hospital Universitario de Salamanca
      • Santander, España, 39008
        • Hospital Universitario Marqués de Valdecilla
      • Valencia, España, 46026
        • Hospital Universitario la Fe
  • Estados Unidos
    • Kansas
      • Westwood, Kansas, Estados Unidos, 66205
        • University of Kansas Medical Center
    • Michigan
      • Ann Arbor, Michigan, Estados Unidos, 48109-1274
        • University of Michigan
    • New York
      • Buffalo, New York, Estados Unidos, 14263
        • Roswell Park Cancer Institute
      • New York, New York, Estados Unidos, 10016
        • New York University Langone Medical Center
    • Pennsylvania
      • Philadelphia, Pennsylvania, Estados Unidos, 19104
        • Perelman Center for Advanced Medicine
    • Washington
      • Edmonds, Washington, Estados Unidos, 98026
        • Swedish Medical Oncology - Edmonds
      • Issaquah, Washington, Estados Unidos, 98029
        • Swedish Cancer Institute - Issaquah
      • Seattle, Washington, Estados Unidos, 98104
        • Swedish Health Services
      • Seattle, Washington, Estados Unidos, 98109
        • University of Washington, Hutchinson Cancer Research Center
      • Seattle, Washington, Estados Unidos, 98122
        • Swedish First Hill Campus
  • Francia
    • Aquitaine
      • Pessac Cedex, Aquitaine, Francia, 33604
        • Hôpital Haut-Lévêque
    • Auvergne
      • Clermont-Ferrand, Auvergne, Francia, 63000
        • CHRU Clermont- Ferrand CHU Estaing
    • Haute-normandie
      • Rouen Cedex 1, Haute-normandie, Francia, 76038
        • Centre Henri-Becquerel
    • Ile-de-france
      • Paris, Ile-de-france, Francia, 75015
        • Hôpital Necker-Enfants Malades
      • Paris Cedex 10, Ile-de-france, Francia, 75475
        • Hopital saint Louis
      • Paris Cedex 13, Ile-de-france, Francia, 75651
        • Groupe Hospitalier - Hopitaux Universitaires Pitie-Salpetriere - Charles-Foix - Pitie-Salpetriere
      • Villejuif Cedex, Ile-de-france, Francia, 94805
        • Institut Gustave Roussy
    • Limousin, Lorraine
      • Limoges Cedex, Limousin, Lorraine, Francia, 87042
        • Hôpital Dupuytren
    • Provence Alpes COTE D'azur
      • Marseille, Provence Alpes COTE D'azur, Francia, 13009
        • Institut Paoli Calmettes Departement de Recherche Clinique et de l'Innovation
    • Rhone-alpes
      • Pierre Benite Cedex, Rhone-alpes, Francia, 69495
        • Centre Hospitalier Lyon Sud
  • Italia
      • Bergamo, Italia, 24127
        • Azienda Ospedaliera Papa Giovanni XXIII
      • Milano, Italia, 20162
        • Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda
      • Novara, Italia, 28100
        • Azienda Ospedaliero-Universitaria "Maggiore della Carità"
      • Udine, Italia, 33100
        • Azienda Ospedaliero Universitaria Santa Maria della Misericordia di Udine
    • Foggia
      • San Giovanni Rotondo, Foggia, Italia, 71013
        • Ospedale Casa Sollievo della Sofferenza
    • Piemonte
      • Torino, Piemonte, Italia, 10126
        • Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino
  • Reino Unido
    • England
      • Birmingham, England, Reino Unido, B15 2GW
        • University Hospitals Birmingham NHS Foundation Trust, Queen Elizabeth Hospital
      • Harrow, England, Reino Unido, HA1 3UJ
        • London North West Healthcare NHS Trust, Imperial College London
      • London, England, Reino Unido, NW1 2BU
        • University College London Hospitals NHS Foundation Trust
      • Manchester, England, Reino Unido, M20 4BX
        • The Christie NHS Foundation Trust
      • Newcastle upon Tyne, England, Reino Unido, NE7 7DN
        • Newcastle Hospitals NHS Foundation Trust

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años y mayores (ADULTO, MAYOR_ADULTO)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  1. 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.

  2. Local pathology review for histological confirmation; A formalin-fixed, paraffin-embedded (FFPE) tumor block or appropriately stained slides from a fresh biopsy is required.
  3. 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.
  4. Documented investigator-assessed relapse or progression after the last treatment is required if the participant responded and then progressed on the prior treatment.
  5. Measurable disease per IWG 2007 criteria.
  6. Eastern Cooperative Oncology Group (ECOG) performance status less than (<) 2.
  7. Life expectancy of greater than (>) 3 months.

  8. Adequate organ function, including the following:

    1. 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).
    2. 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.
    3. Renal: creatinine clearance >=60 milliliter per minute (mL/min).

    4. 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).

Exclusion Criteria:

  1. Central nervous system (CNS) lymphoma; active brain or leptomeningeal metastases.
  2. Known human immunodeficiency virus (HIV)-related malignancy.
  3. 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).
  4. 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.
  5. Known HIV positive, hepatitis B surface antigen positive or known or suspected active hepatitis C infection.
  6. 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.
  7. Participants with certain cardiovascular conditions are excluded.
  8. Major surgery within 14 days before the first dose of study drug or incomplete recovery from any complications from surgery.
  9. Systemic infection requiring parenteral antibiotic therapy or other serious infection (bacterial, fungal, or viral) within 21 days before the first dose of study drug.
  10. Treatment with high-dose corticosteroids for anticancer purposes within 7 days before the first dose of TAK-659.
  11. 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.
  12. Known gastrointestinal (GI) disease or GI procedure that could interfere with the oral absorption or tolerance of TAK-659.
  13. 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.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: TRATAMIENTO
  • Asignación: ALEATORIZADO
  • Modelo Intervencionista: PARALELO
  • Enmascaramiento: NINGUNO

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
EXPERIMENTAL: Cohort A: TAK-659 100 mg
TAK-659 100 mg tablet, orally, once daily (QD), during each 28-days cycle (median exposure was 41 days).
Droga: TAK-659
TAK-659 Tabletas
EXPERIMENTAL: Cohort B: TAK-659 Ramp-up Dosing
TAK-659 60-100 mg tablet, orally, QD, dose based on safety and tolerability during each 28-days cycle (median exposure was 28 days).
Droga: TAK-659
TAK-659 Tabletas

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Stage 2: ORR as Assessed by Independent Radiologic Review Committee (IRRC) Based on Modified 2007 International Working Group (IWG) Criteria
Periodo de tiempo: Up to 12 months
ORR was defined as the percentage of participants with complete response (CR), or partial response (PR) as assessed by IRRC according to the modified 2007 IWG criteria for malignant lymphoma. CR was defined as disappearance of all evidence of disease. PR was defined as regression of measurable disease and no new sites.
Up to 12 months

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Stage 2: CR Rate as Assessed by IRC Based on Modified 2007 IWG Criteria
Periodo de tiempo: Up to 12 months
CR rate was defined as percentage of participants with complete response as assessed by IRC according to the modified 2007 IWG. CR was defined as disappearance of all evidence of disease.
Up to 12 months
Stage 2: ORR as Assessed by IRRC Based on 2014 IWG-Lugano Criteria
Periodo de tiempo: Up to 12 months
ORR was defined as the percentage of participants with CR or PR as assessed by IRRC according to the 2014 Lugano classification, IWG criteria for malignant lymphoma. CR was defined as disappearance of all evidence of disease. PR was defined as regression of measurable disease and no new sites.
Up to 12 months
Stage 2: CR Rate as Assessed by IRRC Based on 2014 IWG-Lugano Criteria
Periodo de tiempo: Up to 12 months
CR rate was defined as percentage of participants with complete response as assessed by IRC according to the 2014 Lugano classification, IWG criteria. CR was defined as disappearance of all evidence of disease.
Up to 12 months
Stage 2: Duration of Response (DOR)
Periodo de tiempo: Up to 12 months
DOR was defined as the time from the date of first documentation of a CR/PR to the date of first documentation of tumor progression or progressive disease (PD) per IRRC assessment according to IWG criteria. CR was defined as disappearance of all evidence of disease. PR was defined as regression of measurable disease and no new sites. PD was defined as presence of any new lesion or increase by >=50% of previously involved sites from nadir.
Up to 12 months
Stage 2: Duration of CR
Periodo de tiempo: Up to 12 months
Duration of CR was defined as the time from the date of first documentation of a CR/PR to the date of first documentation of tumor progression or PD per IRRC assessment according to IWG criteria. CR was defined as disappearance of all evidence of disease. PR was defined as regression of measurable disease and no new sites. PD was defined as presence of any new lesion or increase by >=50% of previously involved sites from nadir.
Up to 12 months
Stage 2: ORR as Assessed by IRRC in Participants With Germinal Center B-cell (GCB) DLBCL
Periodo de tiempo: Hasta 12 meses
ORR was defined as the percentage of participants with CR or PR as assessed by IRRC according to the modified 2007 IWG criteria for malignant lymphoma. CR was defined as disappearance of all evidence of disease. PR was defined as regression of measurable disease and no new sites.
Hasta 12 meses
Stage 2: ORR as Assessed by IRC in Participants With DLBCL Transformed From Indolent Non-Hodgkin's Lymphoma (NHL)
Periodo de tiempo: Up to 12 months
ORR was defined as the percentage of participants with CR or PR as assessed by IRC according to the modified 2007 IWG criteria for malignant lymphoma. CR was defined as disappearance of all evidence of disease. PR was defined as regression of measurable disease and no new sites.
Up to 12 months
Stage 2: Progression Free Survival (PFS) as Assessed by IRC
Periodo de tiempo: Up to 18 months
PFS was defined as time from start of study treatment to first documentation of PD per IRC assessment or up to death due to any cause, whichever occurs first based on IWG criteria. PD was defined as presence of any new lesion or increase by >=50% of previously involved sites from nadir.
Up to 18 months
Stage 2: Overall Survival (OS)
Periodo de tiempo: Up to 24 months
OS was defined as the time from start of study treatment to date of death due to any cause.
Up to 24 months
Stage 1: ORR as Assessed by IRRC to Select Stage 2 Dose Regimen of TAK-659 From the Lead-in Dose Exploration Phase
Periodo de tiempo: Up to 12 months
ORR was defined as the percentage of participants with CR or PR as assessed by IRC. CR was defined as disappearance of all evidence of disease. PR was defined as regression of measurable disease and no new sites.
Up to 12 months
Stage 2: ORR as Assessed by IRC at 3, 6, and 9 Cycles in Participants With DLBCL
Periodo de tiempo: At Cycles 3, 6 and 9 (Up to 12 months) (Each cycle of 28 days)
ORR was defined as the percentage of participants with CR or PR as assessed by IRC according to the modified 2007 IWG criteria for malignant lymphoma. CR was defined as disappearance of all evidence of disease. PR was defined as regression of measurable disease and no new sites.
At Cycles 3, 6 and 9 (Up to 12 months) (Each cycle of 28 days)

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Calithera Biosciences, Inc

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (ACTUAL)

10 de octubre de 2017

Finalización primaria (ACTUAL)

17 de diciembre de 2019

Finalización del estudio (ACTUAL)

17 de diciembre de 2019

Fechas de registro del estudio

Enviado por primera vez

17 de abril de 2017

Primero enviado que cumplió con los criterios de control de calidad

20 de abril de 2017

Publicado por primera vez (ACTUAL)

21 de abril de 2017

Actualizaciones de registros de estudio

Última actualización publicada (ACTUAL)

8 de febrero de 2023

Última actualización enviada que cumplió con los criterios de control de calidad

6 de febrero de 2023

Última verificación

1 de febrero de 2023

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • C34004
  • U1111-1187-6208 (OTRO: WHO)
  • 2016-003716-12 (EUDRACT_NUMBER)
  • 17/YH/0181 (REGISTRO: NRES)

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

SÍ

Descripción del plan IPD

Takeda makes patient-level, de-identified data sets and associated documents available for all interventional studies after applicable marketing approvals and commercial availability have been received (or program is completely terminated), an opportunity for the primary publication of the research and final report development has been allowed, and other criteria have been met as set forth in Takeda's Data Sharing Policy (see www.TakedaClinicalTrials.com for details). To obtain access, researchers must submit a legitimate academic research proposal for adjudication by an independent review panel, who will review the scientific merit of the research and the requestor's qualifications and conflict of interest that can result in potential bias. Once approved, qualified researchers who sign a data sharing agreement are provided access to these data in a secure research environment.

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

Sí

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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