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A Phase 3 Efficacy, Safety and Tolerability Study of Zolbetuximab (Experimental Drug) Plus mFOLFOX6 Chemotherapy Compared to Placebo Plus mFOLFOX6 as Treatment for Gastric and Gastroesophageal Junction (GEJ) Cancer (Spotlight)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03504397
Recruitment Status : Active, not recruiting
First Posted : April 20, 2018
Last Update Posted : May 18, 2022
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc ( Astellas Pharma Global Development, Inc. )

Brief Summary:

A study of zolbetuximab (IMAB362) plus mFOLFOX6 versus placebo plus mFOLFOX6 in subjects with Claudin 18.2 positive, HER2-negative, locally advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma.

Why is this study being done?

SPOTLIGHT is a new clinical study for adult patients who have any of:

  • advanced unresectable gastric or GEJ cancer
  • metastatic gastric or GEJ cancer These types of cancers have a unique set of proteins (called Claudin 18.2). We may be able to use a treatment that targets the proteins to kill the cancer cells.

For patients with one of the types of cancer listed above, mFOLFOX6 (a combination of three chemotherapies known as Oxaliplatin, Leucovorin, and Fluorouracil) is a current treatment option. This study is testing an experimental medicine called zolbetuximab (IMAB362). Zolbetuximab attaches itself to Claudin 18.2 on the cancer cells causing cancer cell death.

Patients will be assigned to one of two groups by chance and given either:

  • zolbetuximab with mFOLFOX6; or
  • a placebo with mFOLFOX6 A placebo is a treatment that looks like the experimental medicine, but contains no medicine.

The goal of the study is to find out if zolbetuximab with mFOLFOX6 helps patients to live longer by stopping the cancer from getting worse.


Condition or disease Intervention/treatment Phase
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 Drug: zolbetuximab Drug: placebo Drug: oxaliplatin Drug: folinic acid Drug: fluorouracil Phase 3

Detailed Description:
The study consists of the following periods: screening; treatment; post-treatment follow up, safety follow up, long term and survival follow-up.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 566 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : June 21, 2018
Estimated Primary Completion Date : August 31, 2022
Estimated Study Completion Date : September 30, 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Arm A (zolbetuximab plus mFOLFOX6)
Participants will receive a loading dose of zolbetuximab at Cycle 1 Day 1 followed by a lower dose in subsequent cycles every 3 weeks. Additionally, participants will receive up to 12 treatments of mFOLFOX6 (or components of mFOLFOX6 if some components are discontinued due to toxicity) over 4 or more cycles (each cycle is approximately 42 days) in which mFOLFOX6 is administered on Days 1, 15 and 29. After 12 mFOLFOX6 treatments, participants may continue to receive fluorouracil (5-FU) and folinic acid at the investigator's discretion until the subject meets study treatment discontinuation criteria.
Drug: zolbetuximab
Zolbetuximab will be administered as a minimum 2-hour IV infusion.
Other Name: IMAB362

Drug: oxaliplatin
Oxaliplatin will be administered as a 2-hour IV infusion

Drug: folinic acid
Folinic acid will be administered as a 2-hour IV infusion.

Drug: fluorouracil
Fluorouracil will be administered as IV bolus over 5-15 minutes and continuous IV infusion over 46-48 hours.

Placebo Comparator: Arm B (Placebo plus mFOLFOX6)
Participants will receive placebo starting at Cycle 1 Day 1 and every 3 weeks thereafter. Additionally, participants will receive up to 12 treatments of mFOLFOX6 (or components of mFOLFOX6 if some components are discontinued due to toxicity) over 4 or more cycles (each cycle is approximately 42 days) in which mFOLFOX6 is administered on Days 1, 15 and 29. After 12 mFOLFOX6 treatments, participants may continue to receive fluorouracil (5-FU) and folinic acid at the investigator's discretion until the subject meets study treatment discontinuation criteria.
Drug: placebo
Placebo will be administered as a minimum 2-hour IV infusion.

Drug: oxaliplatin
Oxaliplatin will be administered as a 2-hour IV infusion

Drug: folinic acid
Folinic acid will be administered as a 2-hour IV infusion.

Drug: fluorouracil
Fluorouracil will be administered as IV bolus over 5-15 minutes and continuous IV infusion over 46-48 hours.




Primary Outcome Measures :
  1. Progression Free Survival (PFS) [ Time Frame: Up to 13 months ]
    PFS is defined as the time from the date of randomization until the date of radiological progressive disease (per Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 by Independent Review Committee (IRC)) or death from any cause, whichever is earliest.


Secondary Outcome Measures :
  1. Overall Survival (OS) [ Time Frame: Up to 23 months ]
    OS is defined as the time from the date of randomization until the date of death from any cause.

  2. Objective Response Rate (ORR) [ Time Frame: Up to 13 months ]
    ORR is defined as the proportion of participants who have a best overall response of Complete Response (CR) or Partial Response (PR) as assessed by Independent Review Committee (IRC) per RECIST 1.1.

  3. Duration Of Response (DOR) [ Time Frame: Up to 13 months ]
    DOR, defined as the time from the date of the first response (CR/PR) until the date of progressive disease as assessed by IRC per RECIST 1.1 or date of death from any cause, whichever is earliest.

  4. Safety and tolerability assessed by adverse events (AEs) [ Time Frame: Up to 16 months ]
    An AE is any untoward medical occurrence in a subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.

  5. Number of participants with laboratory assessments abnormalities and or adverse events [ Time Frame: Up to 14 months ]
    Number of participants with potentially clinically significant laboratory values.

  6. Number of participants with vital signs abnormalities and or adverse events [ Time Frame: Up to 14 months ]
    Number of participants with potentially clinically significant vital sign values.

  7. Number of participants with electrocardiograms (ECG) abnormalities and or adverse events [ Time Frame: Up to 14 months ]
    Number of participants with potentially clinically significant ECG values.

  8. Number of participants with Eastern Cooperative Oncology Group (ECOG) performance status abnormalities and or adverse events [ Time Frame: Up to 13 months ]
    Number of participants with potentially clinically significant ECOG performance status values. ECOG grades 0-5, where 0 = Fully active, able to carry on all pre-disease performance without restriction; 1 = Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work; 2 = Ambulatory and capable of all self-care but unable to carry out any work activities. Up and about more than 50% of waking hours; 3 = Capable of only limited self-care, confined to bed or chair more than 50% of waking hours; 4 = Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair and 5 = Dead.

  9. Health Related Quality of Life (HRQoL) measured by the European Organization for Research and Treatment of Cancer (EORTC-QLQ-C30) questionnaire [ Time Frame: Up to 16 months ]
    The EORTC-QLQ-C30 is a cancer-specific instrument consisting of 5 functional domain scales: physical, role, emotional, social and cognitive.

  10. HRQoL measured by the QLQ-OG25 questionnaire [ Time Frame: Up to 16 months ]
    The EORTC-QLQ-OG25 instrument evaluates Gastric and GEJ cancer-specific symptoms such as stomach discomfort, difficulties eating and swallowing and indigestion.

  11. HRQoL measured by the Global Pain (GP) questionnaire [ Time Frame: Up to 16 months ]
    The GP instrument is a single assessment of overall pain.

  12. HRQoL measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) questionnaire [ Time Frame: Up to 16 months ]
    The EQ-5D-5L is a standardized instrument developed by the EuroQol Group for use as a generic, preference-based measure of health outcomes. The EQ-5D-5L is a 5-item self-reported measure of functioning and wellbeing, which assesses 5 dimensions of health, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension comprises 5 levels (no problems, slight problems, moderate problems, severe problems, extreme problems). A unique EQ-5D-5L health state is defined by combining 1 level from each of the 5 dimensions. This questionnaire also records the respondent's self-rated health status on a vertical graduated (0 = the worst health a participant can imagine to 100 = the best health a participant can imagine) visual analogue scale. Responses to the 5 items will also be converted to a weighted health state index (utility score) based on values derived from general population samples.

  13. Time to confirmed deterioration (TTCD) [ Time Frame: Up to 16 months ]
    Calculated using the physical function (PF), OG25-Pain and Global Health Status (GHS)/QoL scores as measured by EORTC QLQ-C30 and QLQ-OG25. TTCD is defined as time to first confirmed deterioration (time from randomization to first clinically meaningful deterioration that is confirmed at the next scheduled visit).

  14. PK of zolbetuximab: Concentration Immediately Prior to Dosing at multiple dosing (Ctrough) [ Time Frame: Up to 16 months ]
    Ctrough will be derived from the PK serum samples collected.

  15. Number of anti-drug antibody (ADA) Positive Participants [ Time Frame: Up to 16 months ]
    Immunogenicity will be measured by the number of participants that are ADA positive.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03504397


Locations
Hide Hide 220 study locations
Layout table for location information
United States, Arizona
University of Arizona
Phoenix, Arizona, United States, 85004
The University of Arizona Medical Center
Tucson, Arizona, United States, 85724
United States, California
CBCC Global Research, Inc. at Comprehensive Blood and Cancer
Bakersfield, California, United States, 93309
City of Hope Nat'l Medical Center
Duarte, California, United States, 91010
St. Jude Hospital Yorba Linda
Fullerton, California, United States, 92835
Pacific Shores Medical Group
Huntington Beach, California, United States, 92648
Loma Linda University
Loma Linda, California, United States, 92354
The Angeles Clinic and Research Institute
Los Angeles, California, United States, 90025
University of California Davis
Sacramento, California, United States, 95817
University of California - San Francisco
San Francisco, California, United States, 94143
United States, Colorado
University of Colorado
Aurora, Colorado, United States, 80045
United States, Connecticut
Memorial Sloan Kettering Cancer Center
Middletown, Connecticut, United States, 07748-3052
United States, Florida
Memorial Cancer Institute - West
Hollywood, Florida, United States, 33021
University of Miami
Miami, Florida, United States, 33136
Orlando Health Inc
Orlando, Florida, United States, 32806
Memorial Hospital West
Pembroke Pines, Florida, United States, 33028
United States, Georgia
Cancer Treatment Centers of America, Atlanta
Newnan, Georgia, United States, 30265
United States, Illinois
Northwestern University Medical Center
Chicago, Illinois, United States, 60611
University of Chicago
Chicago, Illinois, United States, 60637
United States, Kentucky
Norton Cancer Institute
Louisville, Kentucky, United States, 40217
United States, Maryland
University of Maryland Medical Center(UMMC)Transplant Center
Baltimore, Maryland, United States, 21201
Maryland Oncology Hematology
Brandywine, Maryland, United States, 20613
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114-2696
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02215
United States, Michigan
Karmanos Cancer Institute
Detroit, Michigan, United States, 48201
United States, Minnesota
Health Partners Institute
Saint Louis Park, Minnesota, United States, 55426
Regions Hospital
Saint Paul, Minnesota, United States, 55101
United States, New Jersey
Memorial Sloan Kettering Cancer Center
Basking Ridge, New Jersey, United States, 07920
Memorial Sloan Kettering Cancer Center
Montvale, New Jersey, United States, 07645
United States, New York
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263
Memorial Sloan Kettering Cancer Center
Commack, New York, United States, 11725
Memorial Sloan Kettering Cancer Center
Harrison, New York, United States, 10604
Mount Sinai School of Medicine
New York, New York, United States, 10029-6574
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Stony Brook University Medical Center
Stony Brook, New York, United States, 11794-9452
Memorial Sloan Kettering Cancer Center
Uniondale, New York, United States, 11553
United States, Ohio
The Ohio State University Medical Center
Columbus, Ohio, United States, 43210
Precision Cancer Research -Dayton Physicians Network
Middletown, Ohio, United States, 45042
United States, Oklahoma
University of Oklahoma Health Science Center
Oklahoma City, Oklahoma, United States, 73104
United States, Oregon
Earle A. Chiles Research Institute
Portland, Oregon, United States, 97213
Oregon Health & Science University
Portland, Oregon, United States, 97239
United States, Pennsylvania
Lancaster General Hospital
Lancaster, Pennsylvania, United States, 17604
Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19107
Cancer Treatment Centers of America, Philadelphia
Philadelphia, Pennsylvania, United States, 19124
United States, Rhode Island
Rhode Island Hospital-Lifespan Cancer Institute
Providence, Rhode Island, United States, 02903
United States, South Dakota
Sanford Cancer Center
Sioux Falls, South Dakota, United States, 57104
United States, Texas
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
United States, Virginia
Inova Dwight and Martha Schar Cancer Institute
Fairfax, Virginia, United States, 22031
United States, Washington
MultiCare Regional Cancer Center - Gig Harbor
Auburn, Washington, United States, 98801
Seattle Cancer Care Alliance
Seattle, Washington, United States, 98109
Australia, Queensland
Site AU61002
Douglas, Queensland, Australia, 4814
Site AU61011
Tugun, Queensland, Australia, 4224
Australia, South Australia
Site AU61008
Adelaide, South Australia, Australia, 5011
Australia, Victoria
Site AU61006
East Bentleigh, Victoria, Australia, 3165
Australia
Site AU61007
Kogarah, Australia, 2217
Belgium
Site BE32007
Edegem, Antwerpen, Belgium, 2650
Site BE32001
Bruxelles, Bruxelles-Capitale, Région De, Belgium, 1200
Site BE32008
Mons, Hainaut, Belgium, 7000
Site BE32002
Bruxelles, Liege, Belgium, 1050
Site BE32012
Gent, Oost-Vlaanderen, Belgium, 9000
Site BE32006
Leuven, Vlaams Brabant, Belgium, 3000
Site BE32005
Brugge, Belgium, 8310
Site BE32004
Brussels, Belgium, 1000
Site BE32011
Charleroi, Belgium, 6000
Site BE32010
Haine-Saint-Paul, Belgium, 7100
Brazil
Site BR55010
Brasília, Distrito Federal, Brazil, 70200-730
Site BR55006
Lajeado, Rio Grande Do Sul, Brazil, 95900000
Site BR55002
Itajai, Santa Catarina, Brazil, 88301-220
Site BR55003
Santo Andre, Sao Paulo, Brazil, 09060-650
Site BR55005
Sao Jose do Rio Preto, Sao Paulo, Brazil, 15090-000
Site BR55007
Barretos, São Paulo, Brazil, 14784-400
Site BR55017
Belo Horizonte, Brazil, 30130-090
Site BR55016
Passo Fundo, Brazil, 99010-260
Site BR55015
Rio de Janeiro, Brazil, 22793-080
Site BR55018
Santa Catarina, Brazil, 88501-003
Site BR55009
São Paulo, Brazil, 01509-900
Site BR55004
São Paulo, Brazil, 08270-070
Canada, Alberta
Site CA15005
Edmonton, Alberta, Canada, T6G 1Z2
Canada, New Brunswick
Site CA15009
Saint-John, New Brunswick, Canada, E2L 4L4
Canada, Ontario
Site CA15011
Toronto, Ontario, Canada, M5G 1X5
Canada, Quebec
Site CA15002
Montreal, Quebec, Canada, H3T 1M5
Site CA15008
Montreal, Quebec, Canada, H4A 3J1
Chile
Site CL56003
Providencia, Santiago, Chile, 7500921
Site CL56008
Providencia, Chile, 7520378
Site CL56005
Santiago, Chile, 8330032
Site CL56007
Valdivia, Chile, 5090000
China, Heilongjiang
Site CN86003
Haerbin, Heilongjiang, China, 150081
China, Jiangsu
Site CN86006
Nanjing, Jiangsu, China, 210008
China, Zhejiang
Site CN86004
Hangzhou Shi, Zhejiang, China, 310003
China
Site CN86009
Beijing, China, 100030
Site CN86002
Beijing, China, 100071
Site CN86005
Hefei, China, 230022
Site CN86001
Xiamen, China
Site CN86008
Zhengzhou, China, 450000
Colombia
Site CO57006
Medellín, Antioquia, Colombia, 574
Site CO57007
Monteria, Córdoba, Colombia, 230002
Site CO57009
Bogota, DC, Colombia, 110231
Site CO57005
Cali, Valle, Colombia
Site CO57001
Cali, Colombia
Site CO57002
Medellin, Colombia, 0574
France
Site FR33009
Dijon, Bourgogne, France, 21079
Site FR33010
Brest Cedex, Bretagne, France, 29609
Site FR33001
Rennes, Bretagne, France, 35042
Site FR33008
Besancon cedex, Franche-Comte, France, 25033
Site FR33011
Montpellier Cedex 5, Languedoc-Roussillon, France, 34298
Site FR33002
Paris cedex, Paris, France, 75970
Site FR33101
St Herblain, Pays-de-la-Loire, France, 44805
Site FR33005
Nice, Provence-Alpes-Côte-d'Azur, France, 06200
Site FR33003
Lyon, Rhone, France, 69008
Site FR33006
Poitiers, Vienne, France, 86021
Site FR33103
Creteil, France, 94000
Site FR33007
Nice Cedex 2, France, 06189
Site FR33104
Saint Priest en Jarez, France, 42270
Germany
Site DE49008
Munich, Bavaria, Germany, 81377
Site DE49007
Munchen, Bayern, Germany, 81925
Site DE49002
Mainz, Rheinland-Pfalz, Germany, 55101
Site DE49021
Halle, Sachsen-Anhalt, Germany, 06108
Site DE49015
Magdeburg, Sachsen-Anhalt, Germany, 39104
Site DE49010
Dresden, Sachsen, Germany, 01307
Site DE49004
Leipzig, Sachsen, Germany, 04103
Site DE49012
Berlin, Germany, 13125
Site DE49011
Berlin, Germany, 13353
Site DE49018
Dresden, Germany, 1067
Site DE49019
Heilbronn, Germany, 74078
Israel
Site IL97206
Kfar Saba, HaMerkaz, Israel, 44281
Site IL97210
HaDarom, Israel, 7030000
Site IL97201
Haifa, Israel, 3109601
Site IL97209
Holon, Israel, 58100
Site IL97202
Jerusalem, Israel, 91031
Site IL97203
Tel Aviv, Israel, 64239
Italy
Site IT39011
Meldola, Forli, Italy, 47014
Site IT39020
Monza, Lombardia, Italy, 20052
Site IT39023
Vicenza, VI, Italy, 36100
Site IT39013
Ancona, Italy, 60126
Site IT39004
Bergamo, Italy, 24127
Site IT39009
Cremona, Italy, 26100
Site IT39006
Milano, Italy, 20132
Site IT39008
Milano, Italy, 20141
Site IT39021
Modena, Italy, 41124
Site IT39016
Padova, Italy, 35128
Site IT39012
Parma, Italy, 43126
Site IT39018
Perugia, Italy, 05100
Site IT39003
Piacenza, Italy, 29100
Site IT39019
Pisa, Italy, 56126
Site IT39022
Reggio Emilia, Italy, 42123
Site IT39015
Roma, Italy, 00128
Site IT39026
Terni, Italy, 5100
Site IT39024
Turin TO, Italy, 5-10126
Japan
Site JP81009
Nagoya, Aichi, Japan
Site JP81003
Kashiwa, Chiba, Japan
Site JP81002
Matsuyama, Ehime, Japan
Site JP81007
Sapporo, Hokkaido, Japan
Site JP81014
Kobe, Hyogo, Japan
Site JP81001
Suita, Osaka, Japan
Site JP81015
Hidaka, Saitama, Japan
Site JP81010
Kitaadachi-gun, Saitama, Japan
Site JP81012
Sunto-gun, Shizuoka, Japan
Site JP81013
Bunkyo-ku, Tokyo, Japan
Site JP81006
Chuo-ku, Tokyo, Japan
Site JP81008
Koto-ku, Tokyo, Japan
Site JP81005
Fukuoka, Japan
Site JP81004
Osaka, Japan
Site JP81011
Osaka, Japan
Korea, Republic of
Site KR82002
Seongnam-si, Gyeonggi-do, Korea, Republic of, 13620
Site KR82009
Suwon-si, Gyeonggido [Kyonggi-do], Korea, Republic of, 16247
Site KR82004
Seoul, Seoul Teugbyeolsi, Korea, Republic of, 06351
Site KR82008
Incheon, Korea, Republic of, 21556
Site KR82003
Seoul, Korea, Republic of, 03080
Site KR82005
Seoul, Korea, Republic of, 05505
Site KR82007
Seoul, Korea, Republic of, 152-703
Site KR82006
Seoul, Korea, Republic of, 6591
Mexico
Site MX52007
Ciudad de México, Distrito Federal, Mexico, 3100
Site MX52002
Mexico, Distrito Federal, Mexico, 06760
Site MX52010
Veracruz, Ver, Veracruz, Mexico, 91900
Site MX52001
Aguascalientes, Mexico, 20230
Site MX52003
Distrito Federal, Mexico, 06720
Site MX52009
Jalisco, Mexico, 45030
Site MX52004
Oaxaca, Mexico
Site MX52008
San Luis De Potosi, Mexico, 78250
Peru
Site PE51004
San Isidro, Lima, Peru, L27
Site PE51003
Arequipa, Peru, 4001
Site PE51005
Lima, Peru, 15036
Site PE51006
Lima, Peru, 15072
Site PE51001
Lima, Peru, L27
Poland
Site PL48004
Lublin, Lubuskie, Poland, 20-090
Site PL48007
Ostroleka, Mazowieckie, Poland, 07-410
Site PL48005
Wieliszew, Mazowieckie, Poland, 05-135
Site PL48002
Brzozow, Podkarpackie, Poland, 36-20
Site PL48009
Warszawa, Poland, 02-781
Spain
Site ES34013
Badalona, Barcelona, Spain, 08028
Site ES34010
Avila, Castilla Y Leon, Spain, 05004
Site ES34011
Alcorcon, Madrid, Spain, 28925
Site ES34005
Barcelona, Spain, 08003
Site ES34016
Barcelona, Spain, 08025
Site ES34015
Barcelona, Spain, 08035
Site ES34019
Burgos, Spain, 09006
Site ES34008
Madrid, Spain, 28007
Site ES34017
Madrid, Spain, 28033
Site ES34004
Madrid, Spain, 28034
Site ES34003
Murcia, Spain, 30120
Site ES34018
Sevilla, Spain, 41009
Site ES34006
Zaragoza, Spain, 50009
Taiwan
Site TW88605
Kwei-Shan, Taoyuan, Taiwan, 333
Site TW88608
Kaohsiung, Taiwan, 80756
Site TW88604
Kaohsiung, Taiwan, 833
Site TW88603
Taichung, Taiwan, 404
Site TW88607
Tainan, Taiwan, 704
Site TW88606
Taipei, Taiwan, 10002
Site TW88601
Taipei, Taiwan, 112
United Kingdom
Site GB44003
Aberdeen, Aberdeenshire, United Kingdom, AB25 2ZN
Site GB44101
London, London, City Of, United Kingdom, SW3 6JJ
Site GB44102
Sutton, Surrey, United Kingdom, SM2 5PT
Site GB44103
Cambridge, United Kingdom, CB2 0QQ
Site GB44009
Coventry, United Kingdom, CV2 2DX
Site GB44104
Dundee, United Kingdom, DD2 4BF
Site GB44008
Leeds, United Kingdom, LS7 9TF
Site GB44002
London, United Kingdom, NW1 2PG
Site GB44004
London, United Kingdom, W1G 6AD
Site GB44001
Manchester, United Kingdom, M20 4BX
Sponsors and Collaborators
Astellas Pharma Global Development, Inc.
Investigators
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Study Director: Global Medical Lead Astellas Pharma Global Development, Inc.
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Responsible Party: Astellas Pharma Global Development, Inc.
ClinicalTrials.gov Identifier: NCT03504397    
Other Study ID Numbers: 8951-CL-0301
2017-002567-17 ( EudraCT Number )
CTR20190258 ( Registry Identifier: ChinaDrugTrials.org.cn )
First Posted: April 20, 2018    Key Record Dates
Last Update Posted: May 18, 2022
Last Verified: May 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Access to anonymized individual participant level data collected during the study, in addition to study-related supporting documentation, is planned for studies conducted with approved product indications and formulations, as well as compounds terminated during development. Studies conducted with product indications or formulations that remain active in development are assessed after study completion to determine if Individual Participant Data can be shared. Conditions and exceptions are described under the Sponsor Specific Details for Astellas on www.clinicalstudydatarequest.com.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Time Frame: Access to participant level data is offered to researchers after publication of the primary manuscript (if applicable) and is available as long as Astellas has legal authority to provide the data.
Access Criteria: Researchers must submit a proposal to conduct a scientifically relevant analysis of the study data. The research proposal is reviewed by an Independent Research Panel. If the proposal is approved, access to the study data is provided in a secure data sharing environment after receipt of a signed Data Sharing Agreement.
URL: https://www.clinicalstudydatarequest.com/

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Astellas Pharma Inc ( Astellas Pharma Global Development, Inc. ):
HER2
IMAB362
leucovorin
fluorouracil
Gastric cancer
claudiximab
zolbetuximab
oxaliplatin
adenocarcinoma
Gastro-Esophageal Junction cancer
HER2 Negative mFOLFOX6
Additional relevant MeSH terms:
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Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Leucovorin
Folic Acid
Fluorouracil
Oxaliplatin
Levoleucovorin
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antidotes
Protective Agents
Vitamin B Complex
Vitamins
Micronutrients
Hematinics