- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT03123393
TAK-659 in Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (DLBCL)
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
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Faktisk)
Fas
- Fas 2
Kontakter och platser
Studieorter
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Aquitaine
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Pessac Cedex, Aquitaine, Frankrike, 33604
- Hôpital Haut-Lévèque
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Auvergne
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Clermont-Ferrand, Auvergne, Frankrike, 63000
- CHRU Clermont- Ferrand CHU Estaing
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Haute-normandie
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Rouen Cedex 1, Haute-normandie, Frankrike, 76038
- Centre Henri-Becquerel
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Ile-de-france
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Paris, Ile-de-france, Frankrike, 75015
- Hôpital Necker-Enfants Malades
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Paris Cedex 10, Ile-de-france, Frankrike, 75475
- Hôpital Saint louis
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Paris Cedex 13, Ile-de-france, Frankrike, 75651
- Groupe Hospitalier - Hopitaux Universitaires Pitie-Salpetriere - Charles-Foix - Pitie-Salpetriere
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Villejuif Cedex, Ile-de-france, Frankrike, 94805
- Institut Gustave Roussy
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Limousin, Lorraine
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Limoges Cedex, Limousin, Lorraine, Frankrike, 87042
- Hôpital Dupuytren
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Provence Alpes COTE D'azur
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Marseille, Provence Alpes COTE D'azur, Frankrike, 13009
- Institut Paoli Calmettes Departement de Recherche Clinique et de l'Innovation
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Rhone-alpes
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Pierre Benite Cedex, Rhone-alpes, Frankrike, 69495
- Centre Hospitalier Lyon Sud
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Kansas
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Westwood, Kansas, Förenta staterna, 66205
- University of Kansas Medical Center
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Michigan
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Ann Arbor, Michigan, Förenta staterna, 48109-1274
- University of Michigan
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New York
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Buffalo, New York, Förenta staterna, 14263
- Roswell Park Cancer Institute
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New York, New York, Förenta staterna, 10016
- New York University Langone Medical Center
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Pennsylvania
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Philadelphia, Pennsylvania, Förenta staterna, 19104
- Perelman Center for Advanced Medicine
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Washington
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Edmonds, Washington, Förenta staterna, 98026
- Swedish Medical Oncology - Edmonds
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Issaquah, Washington, Förenta staterna, 98029
- Swedish Cancer Institute - Issaquah
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Seattle, Washington, Förenta staterna, 98104
- Swedish Health Services
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Seattle, Washington, Förenta staterna, 98109
- University of Washington, Hutchinson Cancer Research Center
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Seattle, Washington, Förenta staterna, 98122
- Swedish First Hill Campus
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Bergamo, Italien, 24127
- Azienda Ospedaliera Papa Giovanni XXIII
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Milano, Italien, 20162
- Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda
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Novara, Italien, 28100
- Azienda Ospedaliero-Universitaria "Maggiore della Carità"
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Udine, Italien, 33100
- Azienda Ospedaliero Universitaria Santa Maria della Misericordia di Udine
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Foggia
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San Giovanni Rotondo, Foggia, Italien, 71013
- Ospedale Casa Sollievo della Sofferenza
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Piemonte
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Torino, Piemonte, Italien, 10126
- Azienda Ospedaliera Universitaria Citta della Salute e della Scienza di Torino
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Quebec, Kanada, G1J 1Z4
- CHU de Quebec -Universite Laval-Hopital de L'Enfant Jesus
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Ontario
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Toronto, Ontario, Kanada, M5G2M9
- Princess Margaret Cancer Center
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Quebec
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Rimouski, Quebec, Kanada, G5L 5T1
- Centre Hospitalier Regional De Rimouski
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Barcelona, Spanien, 08036
- Hospital Clínic de Barcelona
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Barcelona, Spanien, 08035
- Hospital Universitari Vall d'Hebron
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Madrid, Spanien, 28046
- Hospital Universitario La Paz
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Madrid, Spanien, 28009
- Hospital General Universitario Gregorio Maranon
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Salamanca, Spanien, 37007
- Hospital Universitario de Salamanca
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Santander, Spanien, 39008
- Hospital Universitario Marques de Valdecilla
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Valencia, Spanien, 46026
- Hospital Universitario La Fe
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England
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Birmingham, England, Storbritannien, B15 2GW
- University Hospitals Birmingham NHS Foundation Trust, Queen Elizabeth Hospital
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Harrow, England, Storbritannien, HA1 3UJ
- London North West Healthcare NHS Trust, Imperial College London
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London, England, Storbritannien, NW1 2BU
- University College London Hospitals NHS Foundation Trust
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Manchester, England, Storbritannien, M20 4BX
- The Christie NHS Foundation Trust
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Newcastle upon Tyne, England, Storbritannien, NE7 7DN
- Newcastle Hospitals NHS Foundation Trust
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria:
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).
Exclusion Criteria:
- 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.
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: BEHANDLING
- Tilldelning: RANDOMISERAD
- Interventionsmodell: PARALLELL
- Maskning: INGEN
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
EXPERIMENTELL: 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).
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TAK-659 tabletter
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EXPERIMENTELL: 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).
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TAK-659 tabletter
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Stage 2: ORR as Assessed by Independent Radiologic Review Committee (IRRC) Based on Modified 2007 International Working Group (IWG) Criteria
Tidsram: 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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Stage 2: CR Rate as Assessed by IRC Based on Modified 2007 IWG Criteria
Tidsram: 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
Tidsram: 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
Tidsram: 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)
Tidsram: Up to 12 months
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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.
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Up to 12 months
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Stage 2: Duration of CR
Tidsram: Up to 12 months
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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.
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Up to 12 months
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Stage 2: ORR as Assessed by IRRC in Participants With Germinal Center B-cell (GCB) DLBCL
Tidsram: Upp till 12 månader
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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.
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Upp till 12 månader
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Stage 2: ORR as Assessed by IRC in Participants With DLBCL Transformed From Indolent Non-Hodgkin's Lymphoma (NHL)
Tidsram: Up to 12 months
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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.
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Up to 12 months
|
Stage 2: Progression Free Survival (PFS) as Assessed by IRC
Tidsram: Up to 18 months
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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.
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Up to 18 months
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Stage 2: Overall Survival (OS)
Tidsram: Up to 24 months
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OS was defined as the time from start of study treatment to date of death due to any cause.
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Up to 24 months
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Stage 1: ORR as Assessed by IRRC to Select Stage 2 Dose Regimen of TAK-659 From the Lead-in Dose Exploration Phase
Tidsram: Up to 12 months
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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
Tidsram: 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.
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At Cycles 3, 6 and 9 (Up to 12 months) (Each cycle of 28 days)
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Samarbetspartners och utredare
Sponsor
Studieavstämningsdatum
Studera stora datum
Studiestart (FAKTISK)
Primärt slutförande (FAKTISK)
Avslutad studie (FAKTISK)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (FAKTISK)
Uppdateringar av studier
Senaste uppdatering publicerad (FAKTISK)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- C34004
- U1111-1187-6208 (ÖVRIG: WHO)
- 2016-003716-12 (EUDRACT_NUMBER)
- 17/YH/0181 (REGISTER: NRES)
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
IPD-planbeskrivning
Läkemedels- och apparatinformation, studiedokument
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H Scott BoswellTakedaAvslutadAML | AML, vuxenFörenta staterna
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