Clinical trial NCT03653507: A Study of Zolbetuximab (IMAB362) Plus CAPOX Compared With Placebo Plus CAPOX 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 (GLOW).
Official title: A Phase 3, Global, Multi-Center, Double-Blind, Randomized, Efficacy Study of Zolbetuximab (IMAB362) Plus CAPOX Compared With Placebo Plus CAPOX 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: CLDN 18.2
gastroesophageal junction cancer
adenocarcinoma
IMAB362
oxaliplatin
HER2
claudiximab
capecitabine
gastric cancer
HER2 Negative
zolbetuximab
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2018-08-31
Enrollment: 507
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 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 stomach 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 people taking part in those countries will leave this study and receive licensed zolbetuximab.

The main aim(s) of the study is(are) to determine the efficacy of zolbetuximab combined with chemotherapy compared to a placebo combined with chemotherapy in treating adults with Claudin 18.2-positive, HER2-negative, locally advanced unresectable or metastatic gastric or GEJ adenocarcinoma.

Adults with locally advanced unresectable or metastatic 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 one of the 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. The chemotherapy is called CAPOX (capecitabine and oxaliplatin) and will be given as an infusion and also as tablets. People will have 1 infusion of either zolbetuximab or placebo together with oxaliplatin chemotherapy in 3-week (21-day) cycles. People will also take 1 tablet of capecitabine (chemotherapy) twice a day for the first 2 weeks (14 days) of each cycle. People may receive zolbetuximab or placebo until their cancer worsens, they cannot tolerate the treatment, or they need to start another cancer treatment. People will receive CAPOX for up to about 6 months (8 treatment cycles). After the 6 months, people may receive capecitabine chemotherapy only, 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 treatment. The study doctors will check if people had any medical problems from 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 within 7 days after they stop their study treatment. People will be asked about any medical problems and will have a health check. People who start treatment with licensed zolbetuximab will not need to attend the clinic for further visits and will receive standard of care health checks. People who continue study treatment will visit the clinic at 1 and 3 months after they stop their study treatment. They will continue to have scans every 9 or 12 weeks to check for any changes in their cancer. They 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 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:

* A female subject is eligible to participate if she is not pregnant (negative serum pregnancy test at screening; female subjects with elevated serum beta human chorionic gonadotropin (βhCG) and a demonstrated non-pregnant status through additional testing are eligible) and at least 1 of the following conditions applies:

  * Not a woman of childbearing potential (WOCBP) OR
  * WOCBP who agrees to follow the contraceptive guidance throughout the treatment period and for 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 treatment 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 male subject with female partner(s) of childbearing potential:

  * must agree to use contraception during the treatment period and for 6 months after the final study treatment administration.
* A male subject must not donate sperm during the treatment period and for 6 months after the final study treatment 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 treatment 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 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 or 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 (Hb) ≥ 9 g/dl. Subjects requiring transfusions are eligible if they have a post-transfusion Hgb ≥ 9 g/dL.
  * Absolute Neutrophil Count (ANC) ≥ 1.5x10\^9/L
  * Platelets ≥ 100x10\^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/international normalized ratio (PT/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 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 treatment with herbal medications or other treatments that have known antitumor activity within 28 days prior to randomization.
* 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 CAPOX.
* Subject has known dihydropyrimidine dehydrogenase (DPD) 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 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 (CNS) 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 co-morbid 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 the date of randomization until 47 months
Secondary outcomes:
measure: Overall Survival (OS)
timeFrame: From the date of randomization untill 47 months
measure: Time to Confirmed Deterioration (TTCD) Using Physical Functioning 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 untill 47 months
measure: Time to Confirmed Deterioration (TTCD) Using Oesophago-gastric Questionnaire (OG25) on Abdominal Pain and Discomfort as Measured by EORTC QLQ-OG25 Plus STO22 Belching Subscale
timeFrame: From the date of randomization untill 47 months
measure: Time to Confirmed Deterioration (TTCD) Using Global Health Status as Measured by EORTC QLQ-C30
timeFrame: From the date of randomization untill 47 months
measure: Objective Response Rate (ORR)
timeFrame: From the date of randomization untill 47 months
measure: Duration Of Response (DOR)
timeFrame: From first response (CR/PR) untill 47 months
measure: Number of Participants With Treatment Emergent Adverse Events (TEAEs)
timeFrame: From first dose untill 47 months
measure: Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status
timeFrame: Baseline, cycle (C) 2 day (D) 1 through C40D1
measure: Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
timeFrame: Baseline, on day (D)1 from cycle (C) 2 through C29, 30-day follow up, 90-day follow up
measure: Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire
timeFrame: Baseline, C2D1 through C29D1, 30-day follow up, 90-day follow up
measure: Change From Baseline in HRQoL Measured by Global Pain (GP)
timeFrame: Baseline, C2D1 through C29D1, 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, C2D1 through C29D1, 30-day follow up, 90-day follow up
measure: Pharmacokinetics (PK) of Zolbetuximab in Serum: Trough Concentration (Ctrough)
timeFrame: Predose on C2D1,C5D1,C9D1,C13D1,C17D1
measure: Number of Anti-drug Antibody (ADA) Positive Participants
timeFrame: Predose on C1D1,C2D1,C5D1,C9D1,C13D1,C17D1, 30-day follow up, 90-day Follow up
Other outcomes:
Locations:
city: Monterey
country: United States
facility: Pacific Cancer Care
state: California
city: Fairway
country: United States
facility: University of Kansas Cancer Center and Medical Pavilion
state: Kansas
city: New Orleans
country: United States
facility: Ochsner Clinic CCOP
state: Louisiana
city: Albuquerque
country: United States
facility: New Mexico Oncology Hematology
state: New Mexico
city: Bronx
country: United States
facility: Montefiore Medical Center (MMC)
state: New York
city: New York
country: United States
facility: Weill Cornell Medical College (WCMC)
state: New York
city: Boiling Springs
country: United States
facility: Prisma Health Cancer Institute
state: South Carolina
city: Dallas
country: United States
facility: Parkland Hospital
state: Texas
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center
state: Texas
city: Houston
country: United States
facility: Houston Methodist Cancer Center and Institute of Academic Medicine - Oncology
state: Texas
city: Salt Lake City
country: United States
facility: Utah Cancer Specialist
state: Utah
city: Buenos Aires
country: Argentina
facility: Site AR54009
city: Northwood
country: Argentina
facility: Site GB44005
city: Pergamino
country: Argentina
facility: Site AR54006
city: San Miguel De Tucuman
country: Argentina
facility: Site AR54001
city: San Miguel de Tucumán
country: Argentina
facility: Site AR54004
city: Viedma
country: Argentina
facility: Site AR54003
city: Chicoutimi
country: Canada
facility: Site CA15003
state: Quebec
city: Rimouski
country: Canada
facility: Site CA15002
state: Quebec
city: Calgary
country: Canada
facility: Site CA15004
city: Fuzhou
country: China
facility: Site CN86034
state: Fujian
city: Fuzhou
country: China
facility: Site CN86037
state: Fujian
city: Haikou
country: China
facility: Site CN86032
state: Hainan
city: Zhengzhou
country: China
facility: Site CN86012
state: Henan
city: Changsha
country: China
facility: Site CN86029
state: Hunan
city: Hengyang
country: China
facility: Site CN86043
state: Hunan
city: Suzhou
country: China
facility: Site CN86027
state: Jiangsu
city: Wuxi
country: China
facility: Site CN86046
state: Jiangsu
city: Hangzhou
country: China
facility: Site CN86007
state: Zhejiang
city: Baoding
country: China
facility: Site CN86044
city: Beijing
country: China
facility: Site CN86035
city: Beijing
country: China
facility: Site CN86050
city: Bengbu
country: China
facility: Site CN86025
city: Changchun
country: China
facility: Site CN86002
city: Changchun
country: China
facility: Site CN86049
city: Changchun
country: China
facility: Site CN86053
city: Changzhou
country: China
facility: Site CN86021
city: Chengdu
country: China
facility: Site CN86039
city: Dalian
country: China
facility: Site CN86052
city: Dalian
country: China
facility: Site CN86054
city: Fuzhou
country: China
facility: Site CN86015
city: Guangzhou
country: China
facility: Site CN86001
city: Guangzhou
country: China
facility: Site CN86042
city: Haebrin
country: China
facility: Site CN86051
city: Hangzhou
country: China
facility: Site CN86036
city: Linyi
country: China
facility: Site CN86038
city: Nanjing
country: China
facility: Site CN86016
city: Nanning
country: China
facility: Site CN86045
city: Shanghai
country: China
facility: Site CN86014
city: Shantou
country: China
facility: Site CN86026
city: Shenyang
country: China
facility: Site CN86047
city: Shijiazhuang
country: China
facility: Site CN86017
city: Tianjin
country: China
facility: Site CN86009
city: Tianjin
country: China
facility: Site CN86040
city: Urumchi
country: China
facility: Site CN86031
city: Wuhan
country: China
facility: Site CN86004
city: Wuhan
country: China
facility: Site CN86005
city: Xi'an
country: China
facility: Site CN86013
city: Xiamen
country: China
facility: Site CN86030
city: Xuzhou
country: China
facility: Site CN86011
city: Zhengzhou
country: China
facility: Site CN86024
city: Varazdin
country: Croatia
facility: Site HR38501
city: Zagreb
country: Croatia
facility: Site HR38502
city: Zagreb
country: Croatia
facility: Site HR38503
city: Athens
country: Greece
facility: Site GR30001
city: Heraklion
country: Greece
facility: Site GR30004
city: Larissa
country: Greece
facility: Site GR30003
city: Neo Faliro, Piraeus
country: Greece
facility: Site GR30005
city: Rio Patras
country: Greece
facility: Site GR30007
city: Thessaloniki
country: Greece
facility: Site GR30002
city: Thessaloniki
country: Greece
facility: Site GR3006
city: Dublin
country: Ireland
facility: Site IE35301
city: Dublin
country: Ireland
facility: Site IE35302
city: Fukuoka-shi
country: Japan
facility: Site JP81007
state: Fukuoka
city: Akashi
country: Japan
facility: Site JP81008
state: Hyogo
city: Kawasaki
country: Japan
facility: Site JP81003
state: Kanagawa
city: Yokohama
country: Japan
facility: Site JP81001
state: Kanagawa
city: Suita
country: Japan
facility: Site JP81010
state: Osaka
city: Utsunomiya
country: Japan
facility: Site JP81005
state: Tochigi
city: Chiba
country: Japan
facility: Site JP81002
city: Kashiwa
country: Japan
facility: Site JP81006
city: Kita-gun
country: Japan
facility: Site JP81004
city: Koto-ku
country: Japan
facility: Site JP81012
city: Matsuyama
country: Japan
facility: Site JP81009
city: Tsukiji
country: Japan
facility: Site JP81011
city: Daegu
country: Korea, Republic of
facility: Site KR82002
city: Goyang-si
country: Korea, Republic of
facility: Site KR82006
city: Gyeonggi-do
country: Korea, Republic of
facility: Site KR82007
city: Incheon
country: Korea, Republic of
facility: Site KR82014
city: Jeollanam-do
country: Korea, Republic of
facility: Site KR82008
city: Jeonju-si
country: Korea, Republic of
facility: Site KR82010
city: Seongnam-si
country: Korea, Republic of
facility: Site KR82011
city: Seoul
country: Korea, Republic of
facility: Site KR82001
city: Seoul
country: Korea, Republic of
facility: Site KR82003
city: Seoul
country: Korea, Republic of
facility: Site KR82012
city: Seoul
country: Korea, Republic of
facility: Site KR82013
city: Seoul
country: Korea, Republic of
facility: Site KR82015
city: Suwon
country: Korea, Republic of
facility: Site KR82009
city: Georgetown
country: Malaysia
facility: Site MY60001
city: Kota Kinabalu
country: Malaysia
facility: Site MY60004
city: Kuala Lumpur
country: Malaysia
facility: Site MY60002
city: Kuala Lumpur
country: Malaysia
facility: Site MY60003
city: Kuala Lumpur
country: Malaysia
facility: Site MY60005
city: Groningen
country: Netherlands
facility: Site NL31004
city: Tilburg
country: Netherlands
facility: Site NL31003
city: Braga
country: Portugal
facility: Site PT35109
city: Coimbra
country: Portugal
facility: Site PT35110
city: Guimaraes
country: Portugal
facility: Site PT35111
city: Lisboa
country: Portugal
facility: Site PT35102
city: Lisboa
country: Portugal
facility: Site PT35106
city: Porto
country: Portugal
facility: Site PT35105
city: Porto
country: Portugal
facility: Site PT35108
city: Santa Maria da Feira
country: Portugal
facility: Site PT35104
city: Setubal
country: Portugal
facility: Site PT35101
city: Vila Real
country: Portugal
facility: Site PT35107
city: Bucharest
country: Romania
facility: Site RO40002
city: Cluj-Napoca
country: Romania
facility: Site RO40005
city: Cluj-Napoca
country: Romania
facility: Site RO40007
city: Craiova
country: Romania
facility: Site RO40003
city: Floresti
country: Romania
facility: Site RO40004
city: Iasi
country: Romania
facility: Site RO40001
city: Iasi
country: Romania
facility: Site RO40006
city: Timisoara
country: Romania
facility: Site RO40008
city: Barcelona
country: Spain
facility: Site ES34006
city: Barcelona
country: Spain
facility: Site ES34009
city: Barcelona
country: Spain
facility: Site ES34010
city: Coruña
country: Spain
facility: Site ES34005
city: Elche
country: Spain
facility: Site ES34001
city: Madrid
country: Spain
facility: Site ES34002
city: Madrid
country: Spain
facility: Site ES34003
city: Madrid
country: Spain
facility: Site ES34008
city: Madrid
country: Spain
facility: Site ES34013
city: Malaga
country: Spain
facility: Site ES34011
city: Pamplona
country: Spain
facility: Site ES34004
city: Valencia
country: Spain
facility: Site ES34007
city: Valencia
country: Spain
facility: Site ES34012
city: Kaohsiung
country: Taiwan
facility: Site TW88602
city: Taichung
country: Taiwan
facility: Site TW88603
city: Taipei
country: Taiwan
facility: Site TW88604
city: Tianan
country: Taiwan
facility: Site TW88605
city: Bangkok
country: Thailand
facility: Site TH66002
city: Bangkok
country: Thailand
facility: Site TH66005
city: Bangkok
country: Thailand
facility: Site TH66007
city: Bangkok
country: Thailand
facility: Site TH66009
city: Laksi
country: Thailand
facility: Site TH66011
city: Muang
country: Thailand
facility: Site TH66001
city: Muang
country: Thailand
facility: Site TH66003
city: Pathumthani
country: Thailand
facility: Site TH66006
city: Pathumwan
country: Thailand
facility: Site TH66010
city: Songkla
country: Thailand
facility: Site TH66004
city: Watthana
country: Thailand
facility: Site TH66008
city: Pendik
country: Turkey
facility: Site TR90008
state: Istanbul
city: Atakum
country: Turkey
facility: Site TR90003
city: Balcali
country: Turkey
facility: Site TR90004
city: Bornova
country: Turkey
facility: Site TR90012
city: Bursa
country: Turkey
facility: Site TR90001
city: Istanbul
country: Turkey
facility: Site TR90002
city: Istanbul
country: Turkey
facility: Site TR90010
city: Istanbul
country: Turkey
facility: Site TR90015
city: Konyaalti
country: Turkey
facility: Site TR90013
city: Konya
country: Turkey
facility: Site TR90007
city: Malatya
country: Turkey
facility: Site TR90011
city: Bristol
country: United Kingdom
facility: Site GB44002
city: Cardiff
country: United Kingdom
facility: Site GB44004
city: London
country: United Kingdom
facility: Site GB44001
Study officials:
affiliation: Astellas Pharma Global Development
name: Medical Director
role: STUDY_DIRECTOR
References: