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

2023年2月6日 更新者：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.

調査の概要

状態

終了しました

条件

介入・治療

詳細な説明

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.

研究の種類

介入

入学 (実際)

49

段階

  • フェーズ2

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

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

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

18年歳以上 (アダルト、OLDER_ADULT)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

全て

説明

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.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 主な目的：処理
  • 割り当て：ランダム化
  • 介入モデル：平行
  • マスキング：なし

武器と介入

参加者グループ / アーム
介入・治療
実験的：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).
薬：TAK-659
TAK-659錠
実験的：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).
薬：TAK-659
TAK-659錠

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Stage 2: ORR as Assessed by Independent Radiologic Review Committee (IRRC) Based on Modified 2007 International Working Group (IWG) Criteria
時間枠：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

二次結果の測定

結果測定
メジャーの説明
時間枠
Stage 2: CR Rate as Assessed by IRC Based on Modified 2007 IWG Criteria
時間枠：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
時間枠：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
時間枠：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)
時間枠：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
時間枠：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
時間枠：12ヶ月まで
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.
12ヶ月まで
Stage 2: ORR as Assessed by IRC in Participants With DLBCL Transformed From Indolent Non-Hodgkin's Lymphoma (NHL)
時間枠：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
時間枠：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)
時間枠：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
時間枠：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
時間枠：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)

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Calithera Biosciences, Inc

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2017年10月10日

一次修了 (実際)

2019年12月17日

研究の完了 (実際)

2019年12月17日

試験登録日

最初に提出

2017年4月17日

QC基準を満たした最初の提出物

2017年4月20日

最初の投稿 (実際)

2017年4月21日

学習記録の更新

投稿された最後の更新 (実際)

2023年2月8日

QC基準を満たした最後の更新が送信されました

2023年2月6日

最終確認日

2023年2月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • C34004
  • U1111-1187-6208 (他の：WHO)
  • 2016-003716-12 (EUDRACT_NUMBER)
  • 17/YH/0181 (レジストリ：NRES)

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

はい

IPD プランの説明

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.

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

はい

米国FDA規制機器製品の研究

いいえ

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

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