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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02227251
Other study ID # KCP-330-009
Secondary ID 2014-001977-15
Status Recruiting
Phase Phase 2
First received
Last updated
Start date November 2014
Est. completion date November 2027

Study information

Verified date June 2024
Source Karyopharm Therapeutics Inc
Contact Karyopharm Medical Information
Phone (888) 209-9326
Email clinicaltrials@karyopharm.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

A multicenter, open-label Phase 2b study of selinexor (KPT-330) in participants with relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL) who have no therapeutic options of demonstrated clinical benefit.


Description:

This is a multicenter, open label, Phase 2b study of the selective inhibitor of nuclear export (SINE) selinexor (40 or 60 milligrams [mg]) given orally (PO) to participants with R/R DLBCL). The study is being conducted in 2 parts (Part 1 and Part 2). For Part 1, a fixed 60 mg dose of selinexor is given orally to 130 participants with R/R DLBCL who have no therapeutic options of demonstrated clinical benefit and who meet eligibility criteria and have none of the exclusion criteria will be enrolled to receive selinexor until either disease progression or intolerance has occurred. For Part 2, approximately 110 participants (55 in each arm) are planned to be enrolled. Participants will be randomized (open label) in a 1:1 ratio to either Arm A (40 mg) or Arm B (60 mg) and will be stratified based on history of prior autologous stem cell transplantation (ASCT) versus no prior ASCT. All the participants will be followed until disease progression and/or death.


Recruitment information / eligibility

Status Recruiting
Enrollment 244
Est. completion date November 2027
Est. primary completion date April 2027
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria (Parts 1 and 2): - Written informed consent in accordance with federal, local, and institutional guidelines. The participant must provide informed consent prior to the first screening procedure. - Age greater than or equal to (=) 18 years. - ECOG performance status of less than or equal to (=) 2. - Participants should have estimated life expectancy of greater than (>) 3 months at study entry. - Previously treated, pathologically confirmed de novo DLBCL, or DLBCL transformed from previously diagnosed indolent lymphoma (e.g., follicular lymphoma). - Participants must have received at least 2 but no more than 5 previous systemic regimens for the treatment of their de novo or transformed DLBCL including (i) at least 1 course of anthracycline-based chemotherapy (unless absolutely contraindicated due to cardiac dysfunction, in which case other active agents such as etoposide, bendamustine, or gemcitabine must have been given) and (ii) at least 1 course of anti-CD20 immunotherapy (e.g., rituximab), unless contraindicated due to severe toxicity. Participants who were considered ineligible for standard multi-agent immunochemotherapy must have received at least 2 and no more than 5 prior treatment regimens including at least 1 course of anti-CD20 antibodies and must be approved by the Medical Monitor. Prior stem cell transplantation is allowed; induction, consolidation, stem cell collection, preparative regimen and transplantation ± maintenance are considered a single line of therapy. - Female participants of child-bearing potential must have a negative serum pregnancy test at screening and agree to use reliable methods of contraception for 3 months after their last dose of medication. Male participants must use a reliable method of contraception if sexually active with a female of child-bearing potential. For both male and female participants, effective methods of contraception must be used throughout the study and for 3 months following the last dose. Part 1 additional inclusion criteria: - For participants whose most recent systemic anti-DLBCL therapy induced a PR or CR, at least 60 days must have elapsed since the end of that therapy. For all other participants, at least 14 weeks (98 days) must have elapsed since the end of their most recent systemic anti-DLBCL therapy. . Palliative localized radiation within the therapy-free interval is allowed. Non-chemotherapy maintenance will not be considered anti DLBCL therapy, and therefore is allowed during the therapy-free interval. - Documented clinical or radiographic evidence of progressive DLBCL prior to dosing. - Participants must have measurable disease per the revised criteria for response assessment of lymphoma. Lymph nodes should be considered abnormal if the long axis is >1.5 centimeter (cm), regardless of the short axis. If a lymph node has a long axis of 1.1 to 1.5 cm, it should only be considered abnormal if its short axis is >1.0. Lymph nodes =1.0 by =1.0 will not be considered abnormal for relapse or PD. Part 2 additional inclusion criteria: • At least 3 weeks (21 days) must have elapsed since the end of participant's most recent systemic anti-DLBCL therapy (prior to Cycle 1 Day 1). Palliative localized radiation within the therapy-free interval is allowed.Non-chemotherapy maintenance will not be considered anti-DLBCL therapy, and therefore is allowed during the therapy-free interval. • Adequate hematopoietic function: (i) Hemoglobin =10.0 grams per deciliters (g/dL) within 14 days of starting therapy (participant may receive red blood cell [RBC] transfusion within 14 days). (ii) Absolute neutrophil count =1000 cells/millimeter (mm^3) (use of granulocyte growth factors prior to and during the study is acceptable). (iii) Platelet count =100,000/mm^3 within 14 days of starting therapy (use of platelet growth factors prior to and during the study is acceptable). - Participants must have measurable disease per the revised criteria for response assessment of lymphoma. Lymph nodes should be considered abnormal if the long axis is >1.5 cm, regardless of the short axis. Extranodal lesion should be considered abnormal if the long axis is >1.0 cm. Exclusion Criteria (Parts 1 and 2): - Participants who are pregnant or lactating. - Primary mediastinal (thymic) large B-cell lymphoma (PMBL) - Participants must not be eligible for high-dose chemotherapy with autologous stem cell transplantation rescue (Investigator must provide detailed documentation for ineligibility). - Participants who have not recovered to Grade =1 clinically significant adverse events, or to their baseline, from their most recent systemic anti-DLBCL therapy. - Major surgery within 2 weeks of first dose of study treatment. - Participants with active hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency virus (HIV) infections. - Psychiatric illness or substance use that would prevent the participant from giving informed consent or being compliant with the study procedures. - Any of the following laboratory abnormalities: (i) A circulating lymphocyte count of >50,000/L. (ii) Hepatic dysfunction: bilirubin >2.0 times the upper limit of normal (ULN) (except participants with Gilbert's syndrome: total bilirubin of >3*ULN) and alanine aminotransferase (ALT) and aspartate aminotransferase (AST) >2.5 times ULN. In participants with known liver involvement of their DLBCL, AST and ALT >5*ULN. (iii) Severe renal dysfunction: estimated creatinine clearance of <30 mL/min, measured in 24-hour urine or calculated using the formula of Cockroft and Gault [(140-Age)*Mass (kg)/(72*creatinine mg/dL); multiply by 0.85 if female]. - Any life-threatening illness, medical condition, or organ system dysfunction which, in the Investigator's opinion, could compromise the participant's safety. - Participants with active graft-versus-host disease after allogeneic stem cell transplantation. At least 4 months must have elapsed since completion of allogeneic stem cell transplantation. - Uncontrolled (i.e., clinically unstable) infection requiring parenteral antibiotics, antivirals, or antifungals on Cycle 1 Day 1; however, prophylactic use of these agents is acceptable even if parenteral. - Participants unable to swallow tablets, participants with malabsorption syndrome, or any other gastrointestinal disease or gastrointestinal dysfunction that could interfere with absorption of study treatment. Part 1 additional exclusion criteria: - For participants whose most recent systemic anti-DLBCL therapy induced a PR or CR: Radiation, chemotherapy, immunotherapy, radio-immunotherapy, or any other anticancer therapy other than glucocorticoids <60 days or <14 weeks prior to Cycle 1 Day 1. - Known central nervous system lymphoma or meningeal involvement. - DLBCL with mucosa-associated lymphoid tissue [MALT] lymphoma, composite lymphoma (Hodgkin's lymphoma+NHL), or DLBCL transformed from diseases other than indolent NHL. - Unstable cardiovascular function: (i) Symptomatic ischemia, or (ii) Uncontrolled clinically significant conduction abnormalities (i.e., ventricular tachycardia on anti-arrhythmia are excluded; 1st degree atrioventricular block or asymptomatic left anterior fascicular block /right bundle branch block will not be excluded), or (iii) Congestive heart failure of New York Heart Association Class =3, or (iv) Myocardial infarction within 3 months. - Participants with a BSA <1.4 m^2 as calculated per Dubois 1916 or Mosteller 1987. - Any of the following laboratory abnormalities: (i) Absolute neutrophil count (ANC) <1000 cells/mm^3 or platelet count <75,000/mm^3 during screening and on Cycle 1 Day 1. Use of granulocyte-stimulating factors and platelet growth factors prior to and during the study is acceptable. (ii) Hematopoietic dysfunction: hemoglobin < 10.0 g/dL within 14 days of and including Cycle 1 Day 1 and/or patients receiving red blood cell (RBC) transfusion within 14 days of and including Cycle 1 Day 1. - Participants who have been committed to an institution by official or judicial order. - Participants with dependency on the Sponsor, Investigator or study site. Part 2 additional exclusion criteria: - Participants with active HBV, HVC, or HIV infections. Participants with active HBV are allowed if antiviral therapy for hepatitis B has been given for >8 weeks and viral load is <100 International units per milliliters (IU/mL) prior to first dose of study treatment. Participants with known history of HCV or found to be HCV antibody positive on screening, are allowed if there is documentation of negative viral load per institutional standard. Participants with HIV who have CD4+T-cell counts =350 cells/microliter (mcL), negative viral load per institutional standard, and no history of acquired immune deficiency syndrome (AIDS)-defining opportunistic infections in the last year are allowed. - Known active central nervous system lymphoma or meningeal involvement. Participants with a history of CNS disease treated into remission may be enrolled. - DLBCL with MALT lymphoma, composite lymphoma (Hodgkin's lymphoma + NHL), DLBCL arising from CLL (Richter's transformation), or high-grade B-cell lymphoma. - Received strong cytochrome P450 3A (CYP3A) inhibitors =7 days prior to Day 1 dosing or strong CYP3A inducers =14 days prior to Day 1 dosing.

Study Design


Intervention

Drug:
Selinexor
Dose: 60 mg (BIW); Dosage form: film-coated (20 mg each) immediate release tablets; Route of administration: Oral
Selinexor
Dose: 40 mg (BIW); Dosage form: film-coated (20 mg each) immediate release tablets; Route of administration: Oral
Selinexor
Dose: 60 mg (BIW) and 60 mg (QW); Dosage form: film-coated (20 mg each) immediate release tablets; Route of administration: Oral

Locations

Country Name City State
Australia Royal Adelaide Hospital Adelaide South Australia
Australia Monash Medical Centre Clayton Victoria
Australia St. Vincent's Hospital Sydney Darlinghurst New South Wales
Australia Epworth Hospital East Melbourne Victoria
Australia St. Vincent's Melbourne Fitzroy Victoria
Australia Ashford Cancer Centre Kurralta Park South Australia
Australia Liverpool Hospital, Ingham Institute of Medical Research Liverpool New South Wales
Australia The Alfred Hospital Melbourne Victoria
Australia Fiona Stanley Hospital Murdoch Western Australia
Australia Icon Cancer Care South Brisbane Queensland
Australia Calvary Mater Newcastle Hospital Waratah New South Wales
Austria Medical University of Graz Graz
Austria Medizinische Universität Innsbruck für Innere Medizin Innsbruck
Austria LKH Leoben Department for Haemato-Oncology Leoben
Austria Akh Linz Innere Med III - Zentrum für Hämatologie und med. Onkologie Linz
Austria Krankenhaus Barmherzigen Schwestern Linz Linz
Austria Krankenhaus der Elisabethinen Linz GmbH Linz
Austria Uni. Klinik für Innere Medizin III Universitätsklinikum der PMU LKH Salzburg Salzburg
Austria Medical University of Vienna (MUW) Department of Medicine I Vienna
Austria Univ. General Hospital Hietzing Vienna
Belgium Ziekenhuis Netwerk Antwerpen Antwerpen
Belgium AZ Sint-Jan Bruges
Belgium Cliniques Universitaires Saint-Luc Brussels
Belgium Institut Jules Bordet Brussels
Belgium UZ Gent Gent
Belgium CH Jolimont La Louviere
Belgium AZ Delta Roeselare
Belgium H-Hartziekenhuis Roeselare-Menen Roeselare
Bulgaria University Hospital for Active Treatment Dr. Georgi Stranski Pleven
Bulgaria Specialized Hospital for Active Treatment of Haematological Diseases EAD Sofia
Bulgaria University Multiprofile Hospital for Active Treatment Sveti Ivan Rilski EAD Sofia
Canada Sir Mortimer B Davis Jewish General Hospital/McGill University Montreal Quebec
Canada Princess Margaret Cancer Centre Toronto Ontario
France Centre Hospitalier Universitaire Henri Mondor Créteil
France Unite Hemopathies Lymphoides Chu Henri Mondor Créteil
France Chu Dijon-Bourgogne - Hematologie Clinique Dijon
France Hospitalier de la Rochelle-Ré-Aunis La Rochelle
France CHRU de Lille - Hopital Claude-Huriez Lille
France Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes Marseille
France CHU Montpellier Montpellier
France Hôpital Necker Service d'Hématologie Adult Paris
France Hostpial Saint Louis - CIRCO (Centre d'Investigations et de Recherche Clinique en Oncologie) Paris
France Pitié-Salpêtrière Hospital Paris
France CHU Lyon Sud Pierre-Bénite Lyon
France Centre Henri Becquerel Rouen
Germany Uniklinik Aachen Klinik für Hämatologie, Onkologie, Hämostaseologie und Stammzelltransplantation Aachen
Germany HELIOS Klinikum Bad Saarow Bad Saarow
Germany Charite Universitatsmedizin Berlin (Benjamin Franklin Campus) Berlin
Germany Charite Universitatsmedizin Berlin (Virchow Campus) Berlin
Germany Ev. Diakonie-Krankenhaus gGmbH Bremen
Germany Gemeinschaftspraxis Haematologie and Onkologie-Dresden Dresden
Germany Martin-Luther-University Halle-Wittenberg Department of Oncology Halle
Germany Medizinische Hochschule Hannover
Germany Universität Heidelberg Medizinische Klinik V Hämatologie, Onkologie und Rheumatologie Heidelberg
Germany Klinikum Kempten Klinik für Innere Medizin III - Hämatologie, Onkologie und Palliativmedizin Koln
Germany Klinikum Leverkusen Leverkusen
Germany Klinikum Ludwigshafen Ludwigshafen
Germany Rotkreuzklinikum München Muenchen
Germany Klinikum Nürnberg Nord Nuernberg
Greece Hematology Clinic,General Hospital of Athens,G. Gennimatos Athens
Greece Hematology Department Laiko General Hospital Athens
Greece National & Kapodistrian University of Athens, Laiko General Hospital Athens
Greece Second Depth of Internal Medicine, Attiko University Hospital Athens
Greece National & Kapodistrian University of Athens, Attiko University Hospital Chaidari
Greece Haematology Department and HCT Unit G.Papanicolaou Hospital Exochi Thessaloniki
Greece Department of clinical hematology ,university hospital Ioannina Ioánnina
Greece University of Patras Medical School Patras
Hungary Országos Onkológiai Intézet "A" Belgyógyászati Onkológiai Osztály Budapest
Hungary Semmelweis Egyetem Általános Orvosi Kar Budapest
Hungary Semmelweis University Department of Medicine and Oncology Budapest
Hungary Somogy Megyei Kaposi Mór Oktató Kórház Kaposvár
Hungary Pécsi Tudományegyetem, ÁOK, I. számú Belgyógyászati Klinika Pécs
Hungary CSolnoky ferenc Hospital Veszprém
Hungary Veszprém Megyei Csolnoky Ferenc Kórház Veszprém
India Institute of Medical Sciences & SUM Hospital Bhubaneswar Odisha
India Cancer Institute (WIA) Chennai Tamil Nadu
India Saveetha Medical College Hospital Chennai Tamil Nadu
India G. Kuppu Swamy Naidu Hospital Coimbatore Tamil Nadu
India IRCH, All India Institute of Medical Sciences Delhi
India Netaji Subhas Chandra Bose Cancer Research Hospital Kolkata West Bengal
India Netaji Subhas Chandra Bose Cancer Research Institute Kolkata West Bengal
India Nil Ratan Sircar Medical College and Hospital Kolkata West Bengal
India TATA Memorial Centre Kolkata West Bengal
India King George's Medical University (KGMU) Lucknow Uttar Pradesh
India Dayanand Medical College and Hospital Ludhiana Punjab
India Meenakshi Mission Hospital & Research Centre Madurai Tamil Nadu
India Jaslok Hospital and Research Centre Mumbai Maharashtra
India Prince Aly Khan Hospital Mumbai Maharashtra
India Dr. B.R.A. Institute Rotary Cancer Hospital All India Institute of Medical Sciences New Delhi
India Rajiv Gandhi Cancer Hospital New Delhi Delhi
India Regional Cancer Centre, IGIMS Patna Bihar
India Deenanath Mangeshkar Hospital Pune Maharashtra
India Regional Cancer Centre Thiruvananthapuram Kerala
India SRM Institutes for Medical Science Vadapalani Chennai
Israel Hematology-Soroka Beer Sheva
Israel Rambam Healthcare Campus Haifa
Israel Wolfson MC Holon
Israel Hadassah Medical Center Jerusalem
Israel Rabin Medical Center Petach Tikva
Israel Assuta Medical Center Tel Aviv
Israel TLV Sorasky Medical Center Tel Aviv
Israel Sheba Medical Center Tel Hashomer
Italy Instituto di Ematologia Seragnoli Pad 8 Universita di Bologna Bologna
Italy AOU Maggiore della Carità SCDU Ematologia Florence
Italy SODc Ematologica ,AOU Careggi Florence
Italy Hematology-Oncology & Stem Cell Transplantation Unit, National Cancer Institute, Fondazione 'G. Pascale', IRCCS Naples
Italy SCDU Ematologia, Division of Hematology, Dept. of Translational Medicine, Universita del Piemonte Orientale Novara
Italy Fondazione Policlinico Universitario A. Gemelli Rome
Italy Azienda Ospedaliero-Universitaria Senese Siena
Italy Città della Salute e della Scienza di Torino Torino
Netherlands VUMc (Vrije Universiteit Amsterdam) Amsterdam
Netherlands LUMC (leidse universitair medisch centrum) Leiden
New Zealand North Shore Hospital Auckland
New Zealand Christchurch Hospital Christchurch
Poland Szpitale Wojewódzkie w Gdyni, Gdynskie Centrum onkologii Gdynia
Poland MCM (Malopolskie Centrum Medyczne) Krakow
Poland Wojewodzki Szpital Specjalistyczny w Legnicy Legnica
Poland Memorial Provincial Specialist Hospital in Lodz Lódz
Poland Hematology Department St John's Cancer Centre Lublin
Poland Samodzielny Publiczny Szpital Kliniczny nr 1 w Lublinie Lublin
Poland Samodzielny Publiczny Zaklad Opieki Zdrowotnej Ministerstwa Olsztyn
Poland Centrum Onkologii- Insytut Im. Marii Sklodowskiej-Curie Klinika Nowotworow Ukladu Chlonnego Warszawa
Poland Instytut Hematologii i Transfuzjologii Warszawa
Poland Maria Sklodowska Curie National Research Institute Warszawa
Poland Uniwersytecki Szpital Kliniczny im. Jana Mikulicza Wroclaw Radeckiego
Serbia Institut za onkologiju i radiologiju Srbije Belgrade
Serbia Klinicki centar Srbije Klinika za hematologiju Belgrade
Serbia Klinicko Bolnick Centar Zemun Odeljenje hematologije Belgrade
Serbia Klinicko bolnicki centar Zvezdara Belgrade
Serbia Klinicki centar Niš Klinika za hematologiju Nis
Serbia Institut za onkologiju Vojvodine Sremska Kamenica
Spain Hospitla Universitari Germans Trias i Pujol - ICO Badalona
Spain Hospital Clinic i Provincial de Barcelona Barcelona
Spain Hospital University Vall d'Hebron Barcelona
Spain Hospital Universitario La Paz Madrid
Spain Hospital de Son Llàtzer Palma de Mallorca
Spain Clínica Universidad De Navarra Pamplona
Spain Hospital Universitario de Salamanca Salamanca
Spain Hospital Universitario Virgen del Rocio Sevilla
United Kingdom Addenbrooke's Hospital Cambridge Cambridge
United Kingdom Gloucestershire Royal Hospital Gloucester Gloucestershire
United Kingdom Northwick Park Hospital Harrow Middlesex
United Kingdom Leeds Teaching Hospitals NHS Trust Leeds Yorkshire
United Kingdom Royal Liverpool University Hospital Liverpool
United Kingdom The Clatterbridge Cancer Centre NHS Foundation Trust Liverpool
United Kingdom Guy's and St Thomas' NHS Foundation Trust London
United Kingdom King's College Hospital London
United Kingdom Princess Royal University Hospital (PRUH) London
United Kingdom The Christie NHS Foundation Trust Manchester
United Kingdom Oxford University Hospitals NHS Trust Oxford Cancer and Haematology Centre, Churchill Hospital Oxford
United Kingdom Derriford Hospital Plymouth
United Kingdom Southampton University Hospital Southampton Hampshire
United Kingdom Royal Marsden Hospital Sutton London
United States Dana Farber Cancer Institute Boston Massachusetts
United States Tufts Medical Center Boston Massachusetts
United States Lahey Clinic Burlington Massachusetts
United States Gabrail Cancer Center Canton Ohio
United States Robert H. Lurie Comprehensive Cancer Center/Northwestern University Chicago Illinois
United States University of Chicago Chicago Illinois
United States Cleveland Clinic Foundation Cleveland Ohio
United States University Hospitals Seidman Cancer Center Cleveland Ohio
United States Greenville Hospital System Greenville South Carolina
United States John Theurer Cancer Center at Hackensack University Medical Center Hackensack New Jersey
United States MD Anderson Houston Texas
United States Clinical Research Alliance Lake Success New York
United States Norton Cancer Institute Louisville Kentucky
United States New York Presbyterian Hospital/ Cornell Medical College New York New York
United States University of Oklahoma Oklahoma City Oklahoma
United States Boca Raton Cancer Research Medical Center Plantation Florida
United States University of California San Francisco San Francisco California
United States University of California Los Angeles (UCLA) Santa Monica California
United States Swedish Cancer Institute Seattle Washington
United States Virginia Mason Hospital & Medical Center Seattle Washington
United States Stony Brook University Hospital Stony Brook New York
United States UACC Arizona Tucson Arizona
United States University of Massachusetts Medical School Worcester Massachusetts

Sponsors (1)

Lead Sponsor Collaborator
Karyopharm Therapeutics Inc

Countries where clinical trial is conducted

United States,  Australia,  Austria,  Belgium,  Bulgaria,  Canada,  France,  Germany,  Greece,  Hungary,  India,  Israel,  Italy,  Netherlands,  New Zealand,  Poland,  Serbia,  Spain,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Part 1: Overall Response Rate (ORR) Assessed according to the revised response criteria based on the Guidelines of the International Working Group (IWG). One year
Primary Part 2: Overall Response Rate (ORR) Based on Lugano Criteria Assessed according to the response assessment of lymphoma based on Lugano classification. From initial randomization until date of disease progression or death (maximum of 1 year from Part 2 randomization)
Secondary Part 1: Duration of Response (DOR) From time of first response until disease progression or death (maximum of 1 year from Part 1 randomization)
Secondary Part 1: Disease Control Rate (DCR) From initial response until disease progression or death (maximum of 1 year from Part 1 randomization)
Secondary Part 1: Number of Participants with Treatment-emergent Adverse Events (TEAEs) From Baseline up to 30 days after last dose (maximum of 1 year from Part 1 randomization)
Secondary Part 1: Number of Participants with Eastern Cooperative Oncology Group (ECOG) Performance Status From Baseline up to 30 days after last dose (maximum of 1 year from Part 1 randomization)
Secondary Part 2: Duration of response (DOR) From time of first response (Part 2) until disease progression or death (maximum of 1 year from Part 2 randomization)
Secondary Part 2: Disease control rate (DCR) From initial response (Part 2) until disease progression or death (maximum of 1 year from Part 2 randomization)
Secondary Part 2: Overall Response Rate (ORR) Based on Modified Lugano Criteria From initial randomization until date of disease progression or death (maximum of 1 year from Part 2 randomization)
Secondary Part 2: Number of Participants with Treatment-emergent Adverse Events From Baseline up to 30 days after last dose (maximum of 1 year from Part 2 randomization)
Secondary Part 2: Number of Participants with Eastern Cooperative Oncology Group (ECOG) Performance Status From Baseline up to 30 days after last dose (maximum of 1 year from Part 2 randomization)
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