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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT02715804
Other study ID # HALO-109-301
Secondary ID 2015-004068-13
Status Terminated
Phase Phase 3
First received
Last updated
Start date March 14, 2016
Est. completion date November 4, 2019

Study information

Verified date June 2020
Source Halozyme Therapeutics
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to compare the efficacy and safety of PEGylated Recombinant Human Hyaluronidase (PEGPH20) combined with nab-paclitaxel plus gemcitabine (PAG treatment), compared with placebo combined with nab-paclitaxel plus gemcitabine (AG treatment), in participants with hyaluronan (HA)-high Stage IV previously untreated pancreatic ductal adenocarcinoma (PDA).


Description:

Participants will be randomized in a 2:1 ratio to PAG or AG treatment.


Recruitment information / eligibility

Status Terminated
Enrollment 492
Est. completion date November 4, 2019
Est. primary completion date November 4, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion criteria:

Participants must satisfy all the following inclusion criteria to be enrolled in the study:

1. Signed, written Institutional Review Board/Ethics Committee-approved Informed Consent Form (ICF).

2. Stage IV PDA with histological or cytological confirmation of PDA.

3. Participants must be determined to be HA-high based on archived or fresh tumor core biopsy or sample obtained after the participant has documented metastatic disease. Biopsies/samples must meet the following requirements:

1. Pancreas tumor biopsies/samples obtained on or after the date that metastatic disease is documented or tumor biopsies/samples from a metastatic lesion are acceptable.

2. Tumor biopsies or samples must meet the requirements provided in the Study Laboratory Manual with regard to tumor tissue architecture. Note: cytology samples from fine needle aspirates without maintained tissue architecture or brushing biopsies are not acceptable.

3. Tumor tissue (formalin-fixed paraffin-embedded [FFPE] block preferred) must include enough tumor to make a minimum of 5-10 unstained, consecutive FFPE slides (10 slides are preferred) of 1 archival block that meet specific tissue sample requirements.

4. Radiographic confirmation of Stage IV PDA with at least 1 tumor metastasis measurable on computed tomography (CT) scan or magnetic resonance imaging (MRI) per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria, excluding the primary pancreatic lesion.

5. If a participant has had adjuvant/neoadjuvant therapy and/or therapy for locally advanced disease (chemotherapy for non-metastatic pancreatic cancer in combination with or without radiation therapy), tumor recurrence or disease progression must have occurred no sooner than 6 months after completing the last dose of the aforementioned therapies, provided all toxicities have returned to baseline or less than or equal to (=) Grade 1.

6. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.

7. Life expectancy greater than or equal to (=) 3 months.

8. Age =18 years.

9. A negative urine or serum pregnancy test within 7 days before Cycle 1, Day 1 (C1D1; first dose of study medication) if female participant is of childbearing potential.

10. Screening clinical laboratory values as follows:

1. Total bilirubin =1.5 times upper limit of normal (ULN) (participants with Gilbert syndrome are eligible independent of bilirubin levels).

2. Aspartate aminotransferase (serum glutamic oxaloacetic transaminase) and alanine aminotransferase (serum glutamic pyruvate transaminase) =2.5 times ULN, (if liver metastases are present, then =5 times ULN is allowed).

3. Serum creatinine =2.0 milligrams/deciliter (mg/dL) or calculated creatinine clearance =40 milliliters/minute (mL/min).

4. Serum albumin =2.5 grams/deciliter (g/dL).

5. Prothrombin time or international normalized ratio (INR) within normal limits (±15%), unless participant takes warfarin, in which case prothrombin time or INR result must be within therapeutic range.

6. Partial thromboplastin time (PTT) within normal limits (±15%).

7. Hemoglobin =9 g/dL (transfusion and erythropoietic agents allowed).

8. Absolute neutrophil count =1,500 cells/cubic millimeter (cells/mm^3).

9. Platelet count =100,000/mm^3.

11. For women of childbearing potential (WOCBP) and for men, agreement to use a highly effective contraceptive method from the time of screening throughout the study until 1 month (WOCBP) or 6 months (men) after administration of the last dose of any study medication. Highly effective contraceptive methods consist of prior sterilization, intrauterine device (IUD), intrauterine hormone-releasing system (IUS), oral or injectable contraceptives, barrier methods, and/or true sexual abstinence.

Exclusion criteria:

Participants are ineligible for enrollment if they meet any of the following exclusion criteria:

1. Clinical evidence of deep vein thrombosis (DVT), pulmonary embolism (PE) or other known thromboembolic (TE) event present during the screening period.

1. Participants with superficial vein thrombosis are eligible.

2. Participants with visceral/splanchnic vein thrombosis are still eligible if, in the opinion of the Investigator, the visceral/splanchnic vein thrombosis is primarily associated with the anatomic location of the underlying disease of metastatic pancreatic cancer (there must be primary or metastatic disease in reasonable proximity to the thrombosis, and the Investigator determines that the thrombosis is due to a local tumor event and not a coagulation issue).

2. Previous radiotherapy, surgery, chemotherapy, or investigational therapy for the treatment of metastatic disease.

a. Palliative radiotherapy for pain control of metastatic bone lesions is allowed.

3. Known central nervous system involvement or brain metastases.

4. New York Heart Association Class III or IV cardiac disease or myocardial infarction within the past 12 months.

5. History of cerebrovascular accident or transient ischemic attack.

6. Clinically significant pre-existing carotid artery disease.

7. Known infection with human immunodeficiency virus, or active infection with hepatitis B or hepatitis C within the past 12 months.

8. Known allergy to hyaluronidase.

9. Current use of megestrol acetate or megestrol acetate-containing drugs (use within 10 days of Day 1).

10. Contraindication to heparin as per institutional guidelines.

11. Women currently pregnant or breastfeeding.

12. Intolerance to dexamethasone.

13. History of another primary cancer within the last 3 years with the exception of non-melanoma skin cancer, early-stage prostate cancer, or curatively treated cervical carcinoma in-situ.

14. Any other disease, active, uncontrolled bacterial, viral or fungal infection requiring systemic therapy, metabolic dysfunction, physical examination finding or clinical laboratory finding that leads to reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug, or that may affect the interpretation of the results, or that may render the participant at high risk for treatment complications.

15. Immunization with a live vaccine up to 2 weeks prior to Day 1.

16. Hypersensitivity to the active substance or ingredients of PEGPH20, gemcitabine, and nab-paclitaxel.

17. Inability to comply with study and follow-up procedures as judged by the Investigator.

Study Design


Intervention

Other:
Biological: PEGylated Recombinant Human Hyaluronidase (PEGPH20)
PEGPH20 will be administered as per the dose and schedule specified in the respective arms.
Drug:
Placebo
Matching placebo for PEGPH20
nab-Paclitaxel
Nab-paclitaxel will be administered as per the dose and schedule specified in the respective arms.
Gemcitabine
Gemcitabine will be administered as per the dose and schedule specified in the respective arms.

Locations

Country Name City State
Australia Bankstown-Lidcombe Hospital Bankstown New South Wales
Australia Flinders Medical Centre Bedford South Australia
Australia Bendigo Health Care Group Bendigo Victoria
Australia Monash Health Bentleigh East Victoria
Australia Chris O'Brien Lifehouse Camperdown New South Wales
Australia St Vincent's Hospital Darlinghurst New South Wales
Australia Peninsula & South Eastern Haematology and Oncology Group Frankston Victoria
Australia Royal North Shore Hospital St Leonards New South Wales
Belgium Imelda Ziekenhuis Bonheiden Antwerpen
Belgium Cliniques Universitaires Saint-Luc Brussels Brussels Capital Region
Belgium Hôpital Erasme Bruxelles Brussels Capital Region
Belgium UZA Edegem Antwerpen
Belgium AZ Maria Middelares - Campus Maria Middelares Gent Oost-Vlaanderen
Belgium UZ Leuven - Campus Gasthuisberg Leuven Vlaams Brabant
Belgium Centre Hospitalier Universitaire (CHU) de Liege - Domaine Un Liege
Brazil Fundacao Pio XII Hospital De Câncer de Barretos Barretos
Brazil CENANTRON - Centro Avançado de Tratamento Oncologico Belo Horizonte Minas Gerais
Brazil Occ -Oncologia Clínica De Campinas Campinas São Paulo
Brazil Fundação Amaral Cravalho / Hospital Amaral Carvalho Jaú São Paulo
Brazil Hospital da Cidade de Passo Fundo Passo Fundo Rio Grande Do Sul
Brazil Hospital de Clinicas de Porto Alegre - UFRGS Porto Alegre Rio Grande Do Sul
Brazil Hospital São Lucas da PUCRS Porto Alegre Rio Grande Do Sul
Brazil Instituto COI Rio de Janeiro
Brazil Instituto Nacional de Câncer - INCA Rio de Janeiro
Brazil Fm Abc/ Cepho Santo Andre São Paulo
Brazil Faculdade de Medicina da Universidade de Sao Paulo Sao Paulo São Paulo
Canada Royal Victoria Regional Health Centre Barrie Ontario
Canada Princess Margaret Hospital Toronto Ontario
Croatia Klinicki bolnicki centar Sestre milosrdnice Zagreb
Croatia Klinicki bolnicki centar Zagreb Zagreb Grad Zagreb
Czechia Masarykuv onkologicky ustav Brno Brno-mesto
Czechia FN Hradec Kralove Hradec Kralove Královéhradecký Kraj
Czechia Fakultni nemocnice Olomouc Olomouc Olomoucký Kraj
Czechia Nemocnice Na Bulovce (Hospital Na Bulovce) Prague
Czechia Fakultni nemocnice v Motole Praha 5
Denmark Odense Universitetshospital Odense South Denmark
Estonia East Tallinn Central Hospital Oncology Center Tallinn Harjumaa
Estonia North Estonian Medical Centre Foundation Clinic of Oncology Tallinn Harjumaa
France Institut de Cancérologie de l'Ouest - Site Paul Papin Angers Cedex 02
France Hospitalier Jean Minjoz Besançon cedex Franche-Comté
France Hôpital Haut-Leveque Bordeaux
France CHU Estaing Clermont-Ferrand Puy-de-Dôme
France Hôpital Beaujon Clichy Cedex Île-de-France
France Henri Mondor - Albert Chevenier Créteil
France Hopital Privé Jean Mermoz Lyon
France Centre Lyon Berard Lyon Cedex
France Hopital Edouard Herriot Lyon Cedex 03 Rhône
France ICM Val d'Aurelle Saint Eloi - Departement Oncologie Montpellier Hérault
France Institut Mutualiste Montsouris Paris
France Pitié Salpetriere Hospital Paris
France Centre Eugene Marquis Rennes Cedex Bretagne
France ICO - Site Ren Gauducheau Saint Herblain Loire-Atlantique
France Institut De Cancerologie Gustave Roussy Villejuif Val-de-Marne
Germany Charité - Universitätsmedizin Berlin Berlin
Germany Universitätsklinikum Bonn Bonn Nordrhein-Westfalen
Germany Universitätsklinik Carl-Gustav-Carus Dresden Dresden Sachsen
Germany Kliniken Essen-Mitte Evang. Huyssens-Stiftung Essen
Germany Universitätsklinikum Halle-Universitätsklinik und Poliklinik Halle
Germany Facharztzentrum Eppendorf Hamburg
Germany Universitätskllinikum Heidelberg Heidelberg
Germany Uniklinik Köln-Klinik für Gastroenterologie und Hepatologie am Abdominalzentrum Koeln Nordrhein-Westfalen
Germany Universitätsklinikum Leipzig AöR Leipzig Sachsen
Germany Klinikum der Universität München - Campus Grosshadern München Bayern
Germany Universitätsklinikum Ulm Ulm Baden-Württemberg
Hungary Egyesített Szent István és Szent László Kórház-Rendelointéze Budapest
Hungary Magyar Honvédség Egészségügyi Központ Budapest
Hungary Országos Onkológiai Intézet Budapest
Hungary Semmelweis Egyetem - Isz. Bel, Onkológiai Részleg Budapest
Hungary Semmelweis Egyetem - Onkohaematológiai Osztály Budapest
Hungary Szent Margit Kórház Budapest
Hungary Debreceni Egyetem Klinikai Központ Debrecen Hajdú-Bihar
Hungary Petz Aladár Megyei Oktató Kórház Gyor Gyor-Moson-Sopron
Hungary Somogy Megyei Kaposi Mór Oktató Kórház Kaposvár
Hungary Pécsi Tudományegyetem Klinikai Központ Pécs Baranya
Hungary Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpo Szeged Csongrád
Israel Ha'Emek Medical Center Afula
Israel Assaf Harofeh Medical Center Be'er Ya'aqov HaMerkaz
Israel Soroka Medical Center [Oncology] Beer Sheva
Israel Hillel Yaffe Medical Center Hadera
Israel Rambam Health Care Campus Haifa
Israel Hadassah Medical Organisation Jerusalem Yerushalayim
Israel Shaare Zedek Medical Center Jerusalem
Israel Meir Medical Center Kfar-Saba HaMerkaz
Israel Rabin Medical Center - Beilinson Hospital Petah Tikva HaMerkaz
Israel Tel Aviv Sourasky Medical Center Tel Aviv Tel-Aviv
Israel The Chaim Sheba Medical Center [Oncology] Tel Hashomer
Italy PO di Cremona, ASST di Cremona Cremona
Italy AO S. Martino, IRCCS, IST-Istituto Nazionale Ricerca Sul Cancro Genova
Italy Ieo, Irccs Milan
Italy IRCCS Ospedale S.Raffaele Milano
Italy Istituto Oncologico Veneto IOV-IRCCS Padova
Italy Regina Elena, Istituto Nazionale dei Tumori, IFO, IRCCS Roma
Italy Istituto Clinico Humanitas Rozzano, IRCCS Rozzano Milano
Italy U.O. di Oncologia San Giovanni Rotondo Foggia
Italy Borgo Roma, Policlinico G.Rossi, AOU Integrata Verona Verona
Korea, Republic of Dong-A University Hospital Busan Busan Gwang'yeogsi
Korea, Republic of Keimyung University Dongsan Medical Center Daegu Daegu Gwang'yeogsi
Korea, Republic of Gachon University Gil Medical Center Incheon
Korea, Republic of Seoul National University Bundang Hospital Seongnam Gyeonggido
Korea, Republic of Asan Medical Center Seoul Seoul Teugbyeolsi
Korea, Republic of Korea University Anam Hospital Seoul Seoul Teugbyeolsi
Korea, Republic of Korea University Guro Hospital Seoul
Korea, Republic of Samsung Medical Center Seoul Seoul Teugbyeolsi
Korea, Republic of Seoul National University Hospital Seoul
Korea, Republic of Severance Hospital, Yonsei University Health System Seoul Seoul Teugbyeolsi
Korea, Republic of The Catholic University of Korea, Seoul St.Mary's Hospital Seoul Seoul Teugbyeolsi
Latvia Daugavpils Regional Hospital Daugavpils
Latvia P.Stradins Clinical University Riga
Latvia SIA "Rigas Austrumu Kliniska Universitates Slimnica" Riga
Lithuania National Cancer Institute Vilnius Vilniaus Apskritis
Lithuania Vilniaus Universiteto ligonines Santariskiu Klinikos Vilnius Vilniaus Apskritis
Netherlands Academisch Medisch Centrum Universiteit van Amsterdam Amsterdam
Netherlands Spaarne Gasthuis Hoofddorp
Netherlands Maastricht University Medical Centre Maastricht Limburg
Netherlands Radboud Universiteit Nijmegen Nijmegen
Poland Szpital Specjalistyczny w Brzozowie Podkarpacki Osrodek Onko Brzozow Podkarpackie
Poland Samodzielny Publiczny Szpital Kliniczny nr 1 w Lublinie Lublin
Poland Centrum Onkologii Instytut im. M. Sklodowskiej-Curie Warszawa
Spain Institut Català d'Oncologia-Hospital Germans Trias i Pujol Badalona Barcelona
Spain H.del Mar Barcelona
Spain H.Sta.Creu i St.Pau Barcelona
Spain H.U.Vall d'Hebrón Barcelona
Spain H.U. de Fuenlabrada Fuenlabrada Madrid
Spain Institut Catalá d´Oncología (I.C.O.) L'Hospitalet De Llobregat Barcelona
Spain H.C. S.Carlos Madrid
Spain H.G.U. G. Marañón Madrid
Spain H.U. F. Jiménez Díaz Madrid
Spain H.U. R. y Cajal Madrid
Spain Hospital Madrid Norte Sanchinarro Madrid
Spain Clínica Universidad de Navarra Pamplona Navarra
Spain F.I. Valenciano de Oncología Valencia
Spain Hospital Universitari i Politècnic La Fe Valencia
Spain H.U. Miguel Servet Zaragoza
Taiwan Changhua Christian Hospital Changhua
Taiwan China Medical University Hospital Taichung Taichung Municipality
Taiwan National Cheng Kung University Hospital Tainan
Taiwan National Taiwan University Hospital Taipei
Taiwan Veterans General Hospital- Taipei Taipei
United Kingdom The Clatterbridge Cancer Centre NHS Foundation Trust Birkenhead Wirral
United Kingdom Queen Elizabeth Hospital Birmingham Birmingham
United Kingdom Addenbrooke's Hospital, Cambridge Cambridge Cambridgeshire
United Kingdom Castle Hill Hospital Cottingham
United Kingdom Coventry Hospital Coventry
United Kingdom Edinburgh Cancer Centre Western General Hospital Edinburgh Midlothian
United Kingdom Beatson West of Scotland Cancer Centre Glasgow Glasgow City
United Kingdom Hammersmith Hospital London
United Kingdom Sarah Cannon Research Institute UK (SCRI UK) London London, City Of
United Kingdom The Royal Marsden NHS Foundation - Sutton London
United Kingdom The Royal Marsden NHS Foundation Trust - Chelsea London
United Kingdom Peterborough And Stamford Hospitals Peterborough Cambridgeshire
United Kingdom North Wales Cancer Treatment Centre Rhyl
United Kingdom The Clatterbridge Cancer Centre NHS Foundation Trust Wirral
United Kingdom The Christie NHS Foundation Trust Withington
United States University of Michigan Medical Center Ann Arbor Michigan
United States The Sidney Kimmel Comprehensive Cancer Center Baltimore Maryland
United States Ochsner Health Center Baton Rouge Louisiana
United States Beth Israel Deaconess Medical Center Boston Massachusetts
United States Gabrail Cancer Center Research Canton Ohio
United States Saint Joseph's Ambulatory Clinic Clifton New Jersey
United States Kaiser Permanente Franklin Medical Offices - Denver Denver Colorado
United States US Oncology - Rocky Mountain Cancer Centers - Midtown Denver Colorado
United States Karmanos Cancer Institute Detroit Michigan
United States Inova Dwight and Martha Schar Cancer Institute Fairfax Virginia
United States Highlands Oncology Group Fayetteville Arkansas
United States Fort Belvoir Community Hospital Fort Belvoir Virginia
United States Fort Wayne Medical Oncology/Hematology, INC. Fort Wayne Indiana
United States St. Jude Hospital Yorba DBA Linda St. Joseph Heritage Health Fullerton California
United States Banner MD Anderson Cancer Center Gilbert Arizona
United States St. Mary's Medical Center Grand Junction Colorado
United States Penn State Milton S. Hershey Medical Center Hershey Pennsylvania
United States Memorial Healthcare System - Memorial Cancer Institute Hollywood Florida
United States Baylor College of Medicine - Baylor Clinic Houston Texas
United States 21st Century Oncology Jacksonville Florida
United States The University Of Kansas Cancer Center Kansas City Kansas
United States Scripps Clinical Research Services La Jolla California
United States Northwell Health/Monter Cancer Center Lake Success New York
United States Comprehensive Cancer Centers of Nevada Las Vegas Nevada
United States Dartmouth Hitchcock Medical Center Lebanon New Hampshire
United States David Geffen School of Medicine (DGSOM) at UCLA Los Angeles California
United States Samuel Oschin Comprehensive Cancer Institute Los Angeles California
United States University of Louisville Louisville Kentucky
United States University of Wisconsin Health - UW Carbone Cancer Center Madison Wisconsin
United States Virginia Cancer Institute Mechanicsville Virginia
United States Columbia St. Marys Milwaukee Wisconsin
United States Medical College of Wisconsin Milwaukee Wisconsin
United States University of Minnesota Medical School Minneapolis Minnesota
United States Virginia Piper Cancer Institute Minneapolis Minnesota
United States University of South Alabama Mobile Alabama
United States Jersey Shore University Medical Center Neptune New Jersey
United States Yale Cancer Center New Haven Connecticut
United States NYU Langone Medical Center - NYU Langone Arena Oncology New Hyde Park New York
United States Ochsner Clinic CCOP New Orleans Louisiana
United States Columbia University Medical Center New York New York
United States Mount Sinai School of Medicine - The Tisch Cancer Institute New York New York
United States The University of Oklahoma Health Sciences Center Oklahoma City Oklahoma
United States Chao Family Comprehensive Cancer Center Orange California
United States St. Joseph Hospital Orange California
United States MD Anderson Cancer Center Orlando Orlando Florida
United States Allegheny General Hospital Pittsburgh Pennsylvania
United States Univ of Pittsburgh Cancer institute Pittsburgh Pennsylvania
United States Rex Cancer Center Raleigh North Carolina
United States Desert Hematology Oncology Medical Group, Inc. Rancho Mirage California
United States Cancer Care Associates Medical Group, Inc. Redondo Beach California
United States Renown Regional Medical Center Reno Nevada
United States University of Rochester Medical Center Rochester New York
United States University of Utah - Huntsman Cancer Institute Salt Lake City Utah
United States Pacific Hematology Oncology Associates San Francisco California
United States UCSF Helen Diller Family Comprehensive Cancer Center San Francisco California
United States Pacific Central Coast Health Centers: San Luis Obispo Oncology and Hematology Health Center San Luis Obispo California
United States St Joseph Heritage Healthcare Santa Rosa California
United States Swedish Cancer Institute/ Swedish Health Services Seattle Washington
United States University of Washington (UW) - Seattle Cancer Care Alliance Seattle Washington
United States Northwest Medical Specialties PLLC Tacoma Washington
United States Scott and White Temple Texas
United States MedStar Georgetown University Hospital Washington District of Columbia
United States Innovative Clinical Research Institution Whittier California
United States UMass Memorial Medical Center Worcester Massachusetts

Sponsors (1)

Lead Sponsor Collaborator
Halozyme Therapeutics

Countries where clinical trial is conducted

United States,  Australia,  Belgium,  Brazil,  Canada,  Croatia,  Czechia,  Denmark,  Estonia,  France,  Germany,  Hungary,  Israel,  Italy,  Korea, Republic of,  Latvia,  Lithuania,  Netherlands,  Poland,  Spain,  Taiwan,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Overall Survival Overall survival was defined as the time from randomization until death from any cause. Overall survival was analyzed using Kaplan-Meier methods. From randomization until death from any cause (maximum exposure: 150.1 weeks for PAG, and 83.9 weeks for AG)
Secondary Progression-Free Survival (PFS) PFS was defined as the time from randomization until the first occurrence of radiological disease progression, as determined by the blinded Central Imaging Vendor (CIV) based on Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1, or death from any cause during the treatment period. Disease progression was defined as at least a 20 percent (%) increase in sum of diameters of target lesions, taking as reference the smallest sum on study thus far, nadir (this included baseline sum if that was the smallest on study); Sum must also demonstrate an absolute increase of at least 5 millimeters (mm); Appearance of one or more new lesions; Unequivocal progression of existing non-target lesions. Surviving participants without disease progression were censored for PFS analysis at the date of last evaluable post-baseline tumor assessment. Surviving participants without any post-baseline disease assessment were censored on Day 1. PFS was estimated using Kaplan-Meier method. From the date of randomization until disease progression or death from any cause (maximum exposure: 150.1 weeks for PAG, and 83.9 weeks for AG)
Secondary Objective Response Rate (ORR): Percentage of Participants With Objective Response ORR was defined as percentage of participants who achieved either a complete response (CR) or partial response (PR) as determined by the blinded CIV based on RECIST version 1.1. CR was defined as disappearance of all target and non-target lesions; Any pathological or non-pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (<) 10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. From the date of randomization until CR or PR (maximum exposure: 150.1 weeks for PAG, and 83.9 weeks for AG)
Secondary Duration of Response (DOR) DOR was defined as the time from the first objective response of CR or PR until disease progression (as determined by the blinded CIV based on RECIST version 1.1) or death within 14 days of last dose of study treatment or randomization. CR was defined as disappearance of all target and non-target lesions; Any pathological or non-pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Disease progression was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study thus far, the sum must also demonstrate an absolute increase of at least 5 mm, or the appearance of one or more new lesions; and unequivocal progression of existing non-target lesions. DOR was analyzed using Kaplan-Meier methods. From date of first objective response (CR or PR) until date of first disease progression (maximum exposure: 150.1 weeks for PAG, and 83.9 weeks for AG)
Secondary Number of Participants With Treatment-Emergent Adverse Events (AEs) An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent AEs were defined as AEs that begin or worsen in severity during or after the participant's first dose of study treatment and no later than 30 days after the date of the last dose of study treatment and/or any treatment-related AE regardless of the onset date. AEs included both SAEs and non-serious AEs. A summary of other non-serious AEs and all SAEs, regardless of causality is located in the 'Reported AE section'. From administration of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 150.1 weeks for PAG, and 83.9 weeks for AG)
Secondary Number of Participants With Worst Post-Baseline Hematology and Chemistry (Clinical Laboratory Parameters) Severity Grade During the Study Severity grade associated with a laboratory parameter value was determined using Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03. Grade 1=mild, Grade 2=moderate, Grade 3=severe, Grade 4=life-threatening. Grade 0 indicates evaluable lab records but not fall into any CTCAE grade for certain CTCAE term. A worst post-baseline grade shift was defined as the worst change that occurred at any measured timepoint during study. Hematology abnormalities: anemia(hemoglobin decreased), lymphocyte count decreased, lymphocyte count increased, neutropenia(neutrophil count decreased), thrombocytopenia(platelet count decreased), and leukopenia(white blood cell decreased). Chemistry abnormalities: hypoalbuminemia, alkaline phosphatase increased, alanine aminotransferase increased, aspartate aminotransferase increased, hyperbilirubinemia, hypo- and hypercalcemia, creatinine increased, hypo- and hyperglycaemia, hypo- and hyperkalemia, hypo- and hypermagnesemia, hypo- and hypernatremia. From administration of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 150.1 weeks for PAG, and 83.9 weeks for AG)
Secondary Number of Participants With Clinically Significant Abnormalities in Electrocardiogram (ECG) ECGs including clinical significance was evaluated by the Investigator. Criteria for clinical significance were as per investigator's discretion. From administration of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 150.1 weeks for PAG, and 83.9 weeks for AG)
Secondary Number of Participants With Clinically Significant Abnormalities in Vital Signs Vital signs included measurement of blood pressure (systolic blood pressure [SBP] and diastolic blood pressure [DBP]), heart rate, and body weight. Criteria for clinical significance abnormalities were: Heart rate: <50 beats per minute (bpm), >120 bpm, >=30 bpm increase from baseline, >=30 bpm decrease from baseline. SBP: >140 millimeters of mercury (mmHg) and increase from baseline >20 mmHg, >180 mmHg, <90 mmHg and decrease from baseline >10 mmHg. DBP: >90 mmHg and increase from baseline >20 mmHg, >105 mmHg, <60 mmHg and decrease from baseline >10 mmHg. Change in weight: >=5% increase from baseline, >=5% decrease from baseline. From administration of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 150.1 weeks for PAG, and 83.9 weeks for AG)
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