Clinical trial NCT03504397: A Study to Compare Zolbetuximab (IMAB362) and Chemotherapy With Placebo and Chemotherapy in Adults With Gastric Cancer.
Official title: A Phase 3, Global, Multi-Center, Double-Blind, Randomized, Efficacy Study of Zolbetuximab (IMAB362) Plus mFOLFOX6 Compared With Placebo Plus mFOLFOX6 as First-line Treatment of Subjects With Claudin (CLDN)18.2-Positive, HER2-Negative, Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Locally Advanced Unresectable Gastroesophageal Junction (GEJ) Adenocarcinoma or Cancer
Locally Advanced Unresectable Gastric Adenocarcinoma or Cancer
Metastatic Gastric Adenocarcinoma or Cancer
Metastatic Gastroesophageal Junction (GEJ) Adenocarcinoma
Keywords: HER2
IMAB362
leucovorin
fluorouracil
Gastric cancer
claudiximab
zolbetuximab
oxaliplatin
adenocarcinoma
Gastro-Esophageal Junction cancer
HER2 Negative mFOLFOX6
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2018-04-20
Enrollment: 565
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Zolbetuximab is being studied in people with cancer in and around the stomach or where the food pipe (esophagus) joins the stomach, called gastroesophageal junction (GEJ) cancer. Most people with this type of cancer have a protein called Claudin 18.2 in their tumor. Zolbetuximab is thought to work by attaching to the Claudin 18.2 protein in their tumor, which switches on the body's immune system to attack the tumor. There is an unmet medical need to treat people with advanced stomach cancer or GEJ cancer. This study will give more information about how well zolbetuximab works when given with chemotherapy in adults with advanced stomach cancer or GEJ cancer. In this study, adults with advanced stomach cancer or GEJ cancer will either be given zolbetuximab with chemotherapy or a placebo with chemotherapy. A placebo looks like zolbetuximab but doesn't have any medicine in it. Zolbetuximab with chemotherapy has already been approved to treat gastric cancer and GEJ cancer in some countries. This study is being done in countries where zolbetuximab has not yet been approved for use. If zolbetuximab becomes approved for use in those countries taking part in this study, the study doctor will switch study treatment in those countries to the licensed zolbetuximab. If this happens, people taking part in those countries will leave this study and receive licensed zolbetuximab.

The main aim of the study is to check if zolbetuximab and chemotherapy can prevent or delay the worsening of people's gastric cancer and GEJ cancer compared to placebo and chemotherapy.

Adults with advanced stomach cancer or GEJ cancer can take part. Locally advanced means the cancer has spread to nearby tissue. Unresectable means the cancer cannot be removed by surgery. Metastatic means the cancer has spread to other parts of the body. A tumor sample of their cancer will also have the Claudin 18.2 protein. They may have been previously treated with certain standard therapies, but have not been treated with chemotherapy for their cancer. People cannot take part if they need to take medicines to suppress their immune system, have blockages or bleeding in their gut, have specific uncontrollable cancers such as symptomatic or untreated cancers in the nervous system, or have a specific heart condition, or infections.

The study treatments are either zolbetuximab with chemotherapy, or placebo with chemotherapy. People who take part will receive just 1 of the study treatments by chance. Study treatment will be double-blinded. That means that the people in the study and the study doctors will not know who takes which of the study treatments. Study treatment will be given in cycles. The study treatment is given to people slowly through a tube into a vein. This is called an infusion. People will have 4 infusions in 6-week (42-day) cycles as follows:

* Zolbetuximab or placebo - 2 infusions in a cycle.
* Chemotherapy (called modified FOLFOX6 or mFOLFOX6) - 3 infusions in a cycle. The first infusion is combined with zolbetuximab or placebo on day 1 of each cycle. People may receive zolbetuximab or placebo until their cancer worsens, they cannot tolerate the study treatment, or they need to start another cancer treatment. People will receive mFOLFOX6 for up to 6 months (4 study treatment cycles). After the 6 months people may receive chemotherapy containing folinic acid and fluorouracil instead of mFOLFOX6. People may receive folinic acid and fluorouracil chemotherapy for more than 6 months, or until their cancer worsens, they cannot tolerate the study treatment, or they need to start another cancer treatment. People will visit the clinic on certain days during their study treatment. The study doctors will check if people had any medical problems from taking zolbetuximab or the other study treatments. Also, people in the study will have health checks. On some visits they will have scans to check for any changes in their cancer. People will have the option of giving a tumor sample after their study treatment has finished. People will visit the clinic after they stop their study treatment. People who start treatment with licensed zolbetuximab or mFOLFOX6 outside of this study will not need to visit the clinic. People will be asked about any medical problems and will have a health check. People will visit the clinic at 1 month after they stop their study treatment. People will continue to have scans every 9 or 12 weeks to check for any changes in their cancer. People will have telephone health checks every 3 months. The number of visits and checks done at each visit will depend on the health of each person and whether they completed their study treatment or not.

Detailed description: After the marketing approval in Japan on 26 Mar 2024, this study continued as "post marketing clinical study" in Japan. In the rest of the countries which participated in this study, this study continued as clinical study.

Eligibility criteria: Inclusion Criteria:

* Female subject eligible to participate if she is not pregnant (negative serum pregnancy test at screening; female subjects with elevated serum beta human chorionic gonadotropin and a demonstrated non-pregnant status through additional testing are eligible) and at least one of the following conditions applies:

  * Not a woman of child-bearing potential (WOCBP) OR
  * WOCBP who agrees to follow the contraceptive guidance throughout the treatment period and for at least 9 months after the final administration of oxaliplatin and 6 months after the final administration of all other study drugs
* Female subject must agree not to breastfeed starting at screening and throughout the study period, and for 6 months after the final study drug administration.
* Female subject must not donate ova starting at screening and throughout the study period, and for 9 months after the final administration of oxaliplatin and 6 months after the final administration of all other study drugs.
* A sexually active male subject with a female partner(s) who is of child-bearing potential must agree to use contraception during the treatment period and for at least 6 months after the final study drug administration.
* Male subject must agree not to donate sperm starting at screening and throughout the study period, and for 6 months after the final study drug administration.
* Male subject with a pregnant or breastfeeding partner(s) must agree to remain abstinent or use a condom for the duration of the pregnancy or time partner is breastfeeding throughout the study period and for 6 months after the final study drug administration.
* Subject has histologically confirmed diagnosis of Gastric or GEJ adenocarcinoma.
* Subject has radiologically confirmed locally advanced unresectable or metastatic disease within 28 days prior to randomization.
* Subject has radiologically evaluable disease (measurable and/or non-measurable disease according to RECIST 1.1), per local assessment, ≤ 28 days prior to randomization. For subjects with only 1 evaluable lesion and prior radiotherapy ≤ 3 months before randomization, the lesion must either be outside the field of prior radiotherapy or have documented progression following radiation therapy.
* Subject's tumor expresses CLDN18.2 in ≥ 75% of tumor cells demonstrating moderate to strong membranous staining as determined by central immunohistochemistry (IHC) testing.
* Subject has a HER2-Negative tumor as determined by local or central testing on a gastric or GEJ tumor specimen. (Unique to China: Subject has a known HER2-negative gastric or GEJ tumor.)
* Subject has ECOG performance status 0 to 1.
* Subject has predicted life expectancy ≥ 12 weeks.
* Subject must meet all of the following criteria based on the centrally or locally analyzed laboratory tests collected within 14 days prior to randomization. In the case of multiple sample collections within this period, the most recent sample collection with available results should be used to determine eligibility.

  * Hemoglobin (Hgb) ≥ 9 g/dL. Subjects requiring transfusions are eligible if they have a post-transfusion Hgb ≥ 9 g/dL.
  * Absolute neutrophil count (ANC) ≥ 1.5 x 10\^9/L
  * Platelets ≥ 100 x 10\^9/L
  * Albumin ≥ 2.5 g/dL
  * Total bilirubin ≤ 1.5 x upper limit of normal (ULN) without liver metastases (or \< 3.0 x ULN if liver metastases are present)
  * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x ULN without liver metastases (or ≤ 5 x ULN if liver metastases are present)
  * Estimated creatinine clearance ≥ 30 mL/min
  * Prothrombin time (PT)/international normalized ratio (INR) and partial thromboplastin time (PTT) ≤ 1.5 x ULN (except for subjects receiving anticoagulation therapy)

Exclusion Criteria:

* Subject has received prior systemic chemotherapy for locally advanced unresectable or metastatic gastric or GEJ adenocarcinoma. However, subject may have received either neo-adjuvant or adjuvant chemotherapy, immunotherapy or other systemic anticancer therapies, as long as it was completed at least 6 months prior to randomization. Subject may have received treatment with herbal medications that have known antitumor activity \> 28 days prior to randomization.
* Subject has received radiotherapy for locally advanced unresectable or metastatic gastric or GEJ adenocarcinoma ≤ 14 days prior to randomization and has not recovered from any related toxicity.
* Subject has received systemic immunosuppressive therapy, including systemic corticosteroids within 14 days prior to randomization. Subjects using a physiologic replacement dose of hydrocortisone or its equivalent (defined as up to 30 mg per day of hydrocortisone or up to 10 mg per day of prednisone), receiving a single dose of systemic corticosteroids or receiving systemic corticosteroids as premedication for radiologic imaging contrast use are allowed.
* Subject has received other investigational agents or devices within 28 days prior to randomization.
* Subject has prior severe allergic reaction or intolerance to known ingredients of zolbetuximab or other monoclonal antibodies, including humanized or chimeric antibodies.
* Subject has known immediate or delayed hypersensitivity, intolerance or contraindication to any component of study treatment.
* Subject has prior severe allergic reaction or intolerance to any component of mFOLFOX6.
* Subject has known dihydropyrimidine dehydrogenase deficiency.
* Subject has a complete gastric outlet syndrome or a partial gastric outlet syndrome with persistent/recurrent vomiting.
* Subject has significant gastric bleeding and/or untreated gastric ulcers that would exclude the subject from participation.
* Subject has a known history of a positive test for human immunodeficiency virus (HIV) infection or known active hepatitis B (positive hepatitis B surface antigen (HBs Ag)) or C infection. NOTE: Screening for these infections should be conducted per local requirements.

  * For subjects who are negative for HBs Ag, but hepatitis B core antibody (HBc Ab) positive, an HB deoxyribonucleic acid (DNA) test will be performed and if positive, the subject will be excluded.
  * Subjects with positive hepatitis C virus (HCV) serology, but negative HCV ribonucleic acid (RNA) test are eligible.
  * Subjects treated for HCV with undetectable viral load results are eligible.
* Subject has an active autoimmune disease that has required systemic treatment within the past 3 months prior to randomization.
* Subject has active infection requiring systemic therapy that has not completely resolved within 7 days prior to randomization.
* Subject has significant cardiovascular disease, including any of the following:

  * Congestive heart failure (defined as New York Heart Association Class III or IV), myocardial infarction, unstable angina, coronary angioplasty, stenting, coronary artery bypass graft, cerebrovascular accident (CVA) or hypertensive crisis within 6 months prior to randomization.
  * History of clinically significant ventricular arrhythmias (i.e., sustained ventricular tachycardia, ventricular fibrillation or Torsades de Pointes)
  * QTc interval \> 450 msec for male subjects; QTc interval \> 470 msec for female subjects
  * History or family history of congenital long QT syndrome
  * Cardiac arrhythmias requiring anti-arrhythmic medications (Subject with rate controlled atrial fibrillation for \> 1 month prior to randomization are eligible).
* Subject has a history of central nervous system metastases and/or carcinomatous meningitis from gastric/GEJ cancer.
* Subject has known peripheral sensory neuropathy \> Grade 1 unless the absence of deep tendon reflexes is the sole neurological abnormality.
* Subject has had a major surgical procedure ≤ 28 days prior to randomization.

  * Subject is without complete recovery from a major surgical procedure ≤ 14 days prior to randomization.
* Subject has psychiatric illness or social situations that would preclude study compliance.
* Subject has another malignancy for which treatment is required.
* Subject has any concurrent disease, infection or comorbid condition that interferes with the ability of the subject to participate in the study, which places the subject at undue risk or complicates the interpretation of data.

Primary outcomes:
measure: Progression Free Survival (PFS)
timeFrame: From date of randomization until the date of first documented radiological progression or date of death from any cause, whichever occurred first (up to 62 months and 18 days)
Secondary outcomes:
measure: Overall Survival (OS)
timeFrame: From the date of randomization until 62 months and 18 days
measure: Time to Confirmed Deterioration (TTCD) Using Physical Functioning (PF) as Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Core Questionnaire (EORTC QLQ-C30)
timeFrame: From the date of randomization until 62 months and 18 days
measure: Time to Confirmed Deterioration (TTCD) Using Oesophago-gastric Questionnaire (OG25) on Abdominal Pain and Discomfort as Measured by EORTC QLQ-OG25
timeFrame: From the date of randomization until 62 months and 18 days
measure: Time to Confirmed Deterioration (TTCD) Using Global Health Status as Measured by EORTC QLQ-C30
timeFrame: From the date of randomization until 62 months and 18 days
measure: Objective Response Rate (ORR)
timeFrame: From the date of randomization until 62 months and 18 days
measure: Duration Of Response (DOR)
timeFrame: From date of first response (CR/PR) until 62 months and 18 day
measure: Number of Participants With Treatment Emergent Adverse Events (TEAEs)
timeFrame: From first dose until 62 months and 18 days
measure: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
timeFrame: Baseline, cycle (C) 1 day (D) 22, D1 and D22 of C2 through C39
measure: Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
timeFrame: Baseline, C1D22, D1 and D22 of C2 through C25, C26D1, C27D1,C28D1 30 day follow up, 90 day follow up
measure: Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
timeFrame: Baseline, C1D22, D1 and D22 of C2 through C25, C26D1, C27D1,C28D1 30 day follow up, 90 day follow up
measure: Change From Baseline in HRQoL Measured by Global Pain (GP)
timeFrame: Baseline, C1D22, D1 and D22 of C2 through C25, C26D1, C27D1,C28D1 30 day follow up, 90 day follow up
measure: Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
timeFrame: Baseline, C1D22, D1 and D22 of C2 through C25, C26D1, C27D1,C28D1 30 day follow up, 90 day follow up
measure: Pharmacokinetics (PK) of Zolbetuximab in Serum: Trough Concentration (Ctrough)
timeFrame: Predose on C1D22, C3D1, C5D1, C7D1, C9D1
measure: Number of Participants With Anti-drug Antibodies (ADA)
timeFrame: Predose on C1D1, C1D22, C3D1, C5D1, C7D1, C9D1, 30-day follow up, 90-day follow up
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: University of Arizona
state: Arizona
city: Tucson
country: United States
facility: The University of Arizona Medical Center
state: Arizona
city: Bakersfield
country: United States
facility: CBCC Global Research, Inc. at Comprehensive Blood and Cancer
state: California
city: Duarte
country: United States
facility: City of Hope Nat'l Medical Center
state: California
city: Fullerton
country: United States
facility: St. Jude Hospital Yorba Linda
state: California
city: Huntington Beach
country: United States
facility: Pacific Shores Medical Group
state: California
city: Loma Linda
country: United States
facility: Loma Linda University
state: California
city: Los Angeles
country: United States
facility: The Angeles Clinic and Research Institute
state: California
city: Sacramento
country: United States
facility: University of California Davis
state: California
city: San Francisco
country: United States
facility: University of California - San Francisco
state: California
city: Aurora
country: United States
facility: University of Colorado
state: Colorado
city: Middletown
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: Connecticut
city: Hollywood
country: United States
facility: Memorial Cancer Institute - West
state: Florida
city: Miami
country: United States
facility: University of Miami
state: Florida
city: Orlando
country: United States
facility: Orlando Health Inc
state: Florida
city: Pembroke Pines
country: United States
facility: Memorial Hospital West
state: Florida
city: Newnan
country: United States
facility: Cancer Treatment Centers of America, Atlanta
state: Georgia
city: Chicago
country: United States
facility: Northwestern University Medical Center
state: Illinois
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
city: Louisville
country: United States
facility: Norton Cancer Institute
state: Kentucky
city: Baltimore
country: United States
facility: University of Maryland Medical Center(UMMC)Transplant Center
state: Maryland
city: Brandywine
country: United States
facility: Maryland Oncology Hematology
state: Maryland
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Boston
country: United States
facility: Dana Farber Cancer Institute
state: Massachusetts
city: Detroit
country: United States
facility: Karmanos Cancer Institute
state: Michigan
city: Saint Louis Park
country: United States
facility: Health Partners Institute
state: Minnesota
city: Saint Paul
country: United States
facility: Regions Hospital
state: Minnesota
city: Basking Ridge
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New Jersey
city: Montvale
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New Jersey
city: Buffalo
country: United States
facility: Roswell Park Cancer Institute
state: New York
city: Commack
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: Harrison
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: New York
country: United States
facility: Mount Sinai School of Medicine
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: Stony Brook
country: United States
facility: Stony Brook University Medical Center
state: New York
city: Uniondale
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: Columbus
country: United States
facility: The Ohio State University Medical Center
state: Ohio
city: Middletown
country: United States
facility: Precision Cancer Research -Dayton Physicians Network
state: Ohio
city: Oklahoma City
country: United States
facility: University of Oklahoma Health Science Center
state: Oklahoma
city: Portland
country: United States
facility: Earle A. Chiles Research Institute
state: Oregon
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
city: Lancaster
country: United States
facility: Lancaster General Hospital
state: Pennsylvania
city: Philadelphia
country: United States
facility: Thomas Jefferson University
state: Pennsylvania
city: Philadelphia
country: United States
facility: Cancer Treatment Centers of America, Philadelphia
state: Pennsylvania
city: Providence
country: United States
facility: Rhode Island Hospital-Lifespan Cancer Institute
state: Rhode Island
city: Sioux Falls
country: United States
facility: Sanford Cancer Center
state: South Dakota
city: Houston
country: United States
facility: The University of Texas MD Anderson Cancer Center
state: Texas
city: Fairfax
country: United States
facility: Inova Dwight and Martha Schar Cancer Institute
state: Virginia
city: Auburn
country: United States
facility: MultiCare Regional Cancer Center - Gig Harbor
state: Washington
city: Seattle
country: United States
facility: Seattle Cancer Care Alliance
state: Washington
city: Douglas
country: Australia
facility: Site AU61002
state: Queensland
city: Tugun
country: Australia
facility: Site AU61011
state: Queensland
city: Adelaide
country: Australia
facility: Site AU61008
state: South Australia
city: East Bentleigh
country: Australia
facility: Site AU61006
state: Victoria
city: Kogarah
country: Australia
facility: Site AU61007
city: Edegem
country: Belgium
facility: Site BE32007
state: Antwerpen
city: Bruxelles
country: Belgium
facility: Site BE32001
state: Bruxelles-Capitale, Région De
city: Mons
country: Belgium
facility: Site BE32008
state: Hainaut
city: Bruxelles
country: Belgium
facility: Site BE32002
state: Liege
city: Gent
country: Belgium
facility: Site BE32012
state: Oost-Vlaanderen
city: Leuven
country: Belgium
facility: Site BE32006
state: Vlaams Brabant
city: Brugge
country: Belgium
facility: Site BE32005
city: Brussels
country: Belgium
facility: Site BE32004
city: Charleroi
country: Belgium
facility: Site BE32011
city: Haine-Saint-Paul
country: Belgium
facility: Site BE32010
city: Brasília
country: Brazil
facility: Site BR55010
state: Distrito Federal
city: Lajeado
country: Brazil
facility: Site BR55006
state: Rio Grande Do Sul
city: Itajai
country: Brazil
facility: Site BR55002
state: Santa Catarina
city: Santo Andre
country: Brazil
facility: Site BR55003
state: Sao Paulo
city: Sao Jose do Rio Preto
country: Brazil
facility: Site BR55005
state: Sao Paulo
city: Barretos
country: Brazil
facility: Site BR55007
state: São Paulo
city: Belo Horizonte
country: Brazil
facility: Site BR55017
city: Passo Fundo
country: Brazil
facility: Site BR55016
city: Rio de Janeiro
country: Brazil
facility: Site BR55015
city: Santa Catarina
country: Brazil
facility: Site BR55018
city: São Paulo
country: Brazil
facility: Site BR55009
city: São Paulo
country: Brazil
facility: Site BR55004
city: Edmonton
country: Canada
facility: Site CA15005
state: Alberta
city: Saint-John
country: Canada
facility: Site CA15009
state: New Brunswick
city: Toronto
country: Canada
facility: Site CA15011
state: Ontario
city: Montreal
country: Canada
facility: Site CA15002
state: Quebec
city: Montreal
country: Canada
facility: Site CA15008
state: Quebec
city: Providencia
country: Chile
facility: Site CL56003
state: Santiago
city: Providencia
country: Chile
facility: Site CL56008
city: Santiago
country: Chile
facility: Site CL56005
city: Valdivia
country: Chile
facility: Site CL56007
city: Haerbin
country: China
facility: Site CN86003
state: Heilongjiang
city: Nanjing
country: China
facility: Site CN86006
state: Jiangsu
city: Hangzhou Shi
country: China
facility: Site CN86004
state: Zhejiang
city: Beijing
country: China
facility: Site CN86009
city: Beijing
country: China
facility: Site CN86002
city: Hefei
country: China
facility: Site CN86005
city: Xiamen
country: China
facility: Site CN86001
city: Zhengzhou
country: China
facility: Site CN86008
city: Medellín
country: Colombia
facility: Site CO57006
state: Antioquia
city: Monteria
country: Colombia
facility: Site CO57007
state: Córdoba
city: Bogota
country: Colombia
facility: Site CO57009
state: DC
city: Cali
country: Colombia
facility: Site CO57005
state: Valle
city: Cali
country: Colombia
facility: Site CO57001
city: Medellin
country: Colombia
facility: Site CO57002
city: Dijon
country: France
facility: Site FR33009
state: Bourgogne
city: Brest Cedex
country: France
facility: Site FR33010
state: Bretagne
city: Rennes
country: France
facility: Site FR33001
state: Bretagne
city: Besancon cedex
country: France
facility: Site FR33008
state: Franche-Comte
city: Montpellier Cedex 5
country: France
facility: Site FR33011
state: Languedoc-Roussillon
city: Paris cedex
country: France
facility: Site FR33002
state: Paris
city: St Herblain
country: France
facility: Site FR33101
state: Pays-de-la-Loire
city: Nice
country: France
facility: Site FR33005
state: Provence-Alpes-Côte-d'Azur
city: Lyon
country: France
facility: Site FR33003
state: Rhone
city: Poitiers
country: France
facility: Site FR33006
state: Vienne
city: Creteil
country: France
facility: Site FR33103
city: Nice Cedex 2
country: France
facility: Site FR33007
city: Saint Priest en Jarez
country: France
facility: Site FR33104
city: Munich
country: Germany
facility: Site DE49008
state: Bavaria
city: Munchen
country: Germany
facility: Site DE49007
state: Bayern
city: Mainz
country: Germany
facility: Site DE49002
state: Rheinland-Pfalz
city: Halle
country: Germany
facility: Site DE49021
state: Sachsen-Anhalt
city: Magdeburg
country: Germany
facility: Site DE49015
state: Sachsen-Anhalt
city: Dresden
country: Germany
facility: Site DE49010
state: Sachsen
city: Leipzig
country: Germany
facility: Site DE49004
state: Sachsen
city: Berlin
country: Germany
facility: Site DE49012
city: Berlin
country: Germany
facility: Site DE49011
city: Dresden
country: Germany
facility: Site DE49018
city: Heilbronn
country: Germany
facility: Site DE49019
city: Kfar Saba
country: Israel
facility: Site IL97206
state: HaMerkaz
city: HaDarom
country: Israel
facility: Site IL97210
city: Haifa
country: Israel
facility: Site IL97201
city: Holon
country: Israel
facility: Site IL97209
city: Jerusalem
country: Israel
facility: Site IL97202
city: Tel Aviv
country: Israel
facility: Site IL97203
city: Meldola
country: Italy
facility: Site IT39011
state: Forli
city: Monza
country: Italy
facility: Site IT39020
state: Lombardia
city: Vicenza
country: Italy
facility: Site IT39023
state: VI
city: Ancona
country: Italy
facility: Site IT39013
city: Bergamo
country: Italy
facility: Site IT39004
city: Cremona
country: Italy
facility: Site IT39009
city: Milano
country: Italy
facility: Site IT39006
city: Milano
country: Italy
facility: Site IT39008
city: Modena
country: Italy
facility: Site IT39021
city: Padova
country: Italy
facility: Site IT39016
city: Parma
country: Italy
facility: Site IT39012
city: Perugia
country: Italy
facility: Site IT39018
city: Piacenza
country: Italy
facility: Site IT39003
city: Pisa
country: Italy
facility: Site IT39019
city: Reggio Emilia
country: Italy
facility: Site IT39022
city: Roma
country: Italy
facility: Site IT39015
city: Terni
country: Italy
facility: Site IT39026
city: Turin TO
country: Italy
facility: Site IT39024
city: Nagoya
country: Japan
facility: Site JP81009
state: Aichi
city: Kashiwa
country: Japan
facility: Site JP81003
state: Chiba
city: Matsuyama
country: Japan
facility: Site JP81002
state: Ehime
city: Sapporo
country: Japan
facility: Site JP81007
state: Hokkaido
city: Kobe
country: Japan
facility: Site JP81014
state: Hyogo
city: Suita
country: Japan
facility: Site JP81001
state: Osaka
city: Hidaka
country: Japan
facility: Site JP81015
state: Saitama
city: Kitaadachi-gun
country: Japan
facility: Site JP81010
state: Saitama
city: Sunto-gun
country: Japan
facility: Site JP81012
state: Shizuoka
city: Bunkyo-ku
country: Japan
facility: Site JP81013
state: Tokyo
city: Chuo-ku
country: Japan
facility: Site JP81006
state: Tokyo
city: Koto-ku
country: Japan
facility: Site JP81008
state: Tokyo
city: Fukuoka
country: Japan
facility: Site JP81005
city: Osaka
country: Japan
facility: Site JP81004
city: Osaka
country: Japan
facility: Site JP81011
city: Seongnam-si
country: Korea, Republic of
facility: Site KR82002
state: Gyeonggi-do
city: Suwon-si
country: Korea, Republic of
facility: Site KR82009
state: Gyeonggido [Kyonggi-do]
city: Seoul
country: Korea, Republic of
facility: Site KR82004
state: Seoul Teugbyeolsi
city: Incheon
country: Korea, Republic of
facility: Site KR82008
city: Seoul
country: Korea, Republic of
facility: Site KR82003
city: Seoul
country: Korea, Republic of
facility: Site KR82005
city: Seoul
country: Korea, Republic of
facility: Site KR82007
city: Seoul
country: Korea, Republic of
facility: Site KR82006
city: Ciudad de México
country: Mexico
facility: Site MX52007
state: Distrito Federal
city: Mexico
country: Mexico
facility: Site MX52002
state: Distrito Federal
city: Veracruz, Ver
country: Mexico
facility: Site MX52010
state: Veracruz
city: Aguascalientes
country: Mexico
facility: Site MX52001
city: Distrito Federal
country: Mexico
facility: Site MX52003
city: Jalisco
country: Mexico
facility: Site MX52009
city: Oaxaca
country: Mexico
facility: Site MX52004
city: San Luis De Potosi
country: Mexico
facility: Site MX52008
city: San Isidro
country: Peru
facility: Site PE51004
state: Lima
city: Arequipa
country: Peru
facility: Site PE51003
city: Lima
country: Peru
facility: Site PE51005
city: Lima
country: Peru
facility: Site PE51006
city: Lima
country: Peru
facility: Site PE51001
city: Lublin
country: Poland
facility: Site PL48004
state: Lubuskie
city: Ostroleka
country: Poland
facility: Site PL48007
state: Mazowieckie
city: Wieliszew
country: Poland
facility: Site PL48005
state: Mazowieckie
city: Brzozow
country: Poland
facility: Site PL48002
state: Podkarpackie
city: Warszawa
country: Poland
facility: Site PL48009
city: Badalona
country: Spain
facility: Site ES34013
state: Barcelona
city: Avila
country: Spain
facility: Site ES34010
state: Castilla Y Leon
city: Alcorcon
country: Spain
facility: Site ES34011
state: Madrid
city: Barcelona
country: Spain
facility: Site ES34005
city: Barcelona
country: Spain
facility: Site ES34016
city: Barcelona
country: Spain
facility: Site ES34015
city: Burgos
country: Spain
facility: Site ES34019
city: Madrid
country: Spain
facility: Site ES34008
city: Madrid
country: Spain
facility: Site ES34017
city: Madrid
country: Spain
facility: Site ES34004
city: Murcia
country: Spain
facility: Site ES34003
city: Sevilla
country: Spain
facility: Site ES34018
city: Zaragoza
country: Spain
facility: Site ES34006
city: Kwei-Shan
country: Taiwan
facility: Site TW88605
state: Taoyuan
city: Kaohsiung
country: Taiwan
facility: Site TW88608
city: Kaohsiung
country: Taiwan
facility: Site TW88604
city: Taichung
country: Taiwan
facility: Site TW88603
city: Tainan
country: Taiwan
facility: Site TW88607
city: Taipei
country: Taiwan
facility: Site TW88606
city: Taipei
country: Taiwan
facility: Site TW88601
city: Aberdeen
country: United Kingdom
facility: Site GB44003
state: Aberdeenshire
city: London
country: United Kingdom
facility: Site GB44101
state: London, City Of
city: Sutton
country: United Kingdom
facility: Site GB44102
state: Surrey
city: Cambridge
country: United Kingdom
facility: Site GB44103
city: Coventry
country: United Kingdom
facility: Site GB44009
city: Dundee
country: United Kingdom
facility: Site GB44104
city: Leeds
country: United Kingdom
facility: Site GB44008
city: London
country: United Kingdom
facility: Site GB44002
city: London
country: United Kingdom
facility: Site GB44004
city: Manchester
country: United Kingdom
facility: Site GB44001
Study officials:
affiliation: Astellas Pharma Global Development, Inc.
name: Global Medical Lead
role: STUDY_DIRECTOR
References: