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| ID | Type | Description | Link |
|---|---|---|---|
| 2018-000519-26 | EudraCT Number | ||
| CTR20190261 | Registry Identifier | ChinaDrugTrials.org.cn | |
| jRCT2080224166 | Registry Identifier | jRCT | |
| 2024-511648-16-00 | Registry Identifier | CTIS (EU) |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Zolbetuximab plus CAPOX | Experimental | Participants received an IV infusion (as a minimum of 2-hour infusion) of zolbetuximab at a loading dose of 800 mg/m^2 on C1D1 followed by subsequent doses of 600 mg/m^2 every 3 weeks starting from C1D22 until participant meets study treatment discontinuation criteria. Participants also received up to 8 treatments of CAPOX. Oxaliplatin was administered 130 mg/m^2 IV on day 1 of each cycle over 2 hours for a maximum of 8 treatments; Capecitabine was administered orally at 1000 mg/m^2 twice daily (bid) on days 1 through 14 of each cycle until the participant met study treatment discontinuation criteria. After a maximum of 8 treatments of oxaliplatin, participants may have continued to receive capecitabine taken twice daily on days 1 through 14 of each cycle at the investigator's discretion until the participant met study treatment discontinuation criteria. Each cycle was approximately 21 days. |
|
| Placebo plus CAPOX | Placebo Comparator | Participants received an IV infusion (as a minimum of 2-hour infusion) of placebo matched to zolbetuximab on C1D1 followed by subsequent doses every 3 weeks starting from C1D22 until participant meets study treatment discontinuation criteria. Participants also received up to 8 treatments of CAPOX. Oxaliplatin was administered 130 mg/m^2 IV on day 1 of each cycle over 2 hours for a maximum of 8 treatments; Capecitabine was administered orally at 1000 mg/m^2 bid on days 1 through 14 of each cycle until the participant met study treatment discontinuation criteria. After a maximum of 8 treatments of oxaliplatin, participants may have continued to receive capecitabine taken twice daily on days 1 through 14 of each cycle at the investigator's discretion until the participant met study treatment discontinuation criteria. Each cycle was approximately 21 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| zolbetuximab | Drug | Zolbetuximab were administered as a minimum 2-hour IV infusion. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival (PFS) | PFS was defined as the time from the date of randomization until the date of radiological progressive disease (PD) (per Response Evaluation Criteria in Solid Tumors [RECIST] 1.1 by independent review committee [IRC]) or death from any cause, whichever was earliest. PD was defined as development of new, or progression of existing metastases to the primary cancer under the study. Kaplan-Meier estimates was used. | From the date of randomization until 61 months and 12 days |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) | OS was defined as the time from the date of randomization until the date of death from any cause. Kaplan-Meier estimates was used. | From the date of randomization until 61 months and 12 days |
| 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) |
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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:
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:
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.
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.
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:
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 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.
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Astellas Pharma Global Development | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pacific Cancer Care | Monterey | California | 93940 | United States | ||
| University of Kansas Cancer Center and Medical Pavilion |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42095986 | Derived | Yamaguchi K, Shoji H, Yasui H, Oki E, Sakai D, Hamaguchi T, Tsuji A, Oshima T, Tsuda M, Minashi K, Yang J, Guerrero A, Ueno Y, Matsangou M, Gourgioti G, Nakanishi Y, Furuki S, Kuwamoto K, Yamada S, Shitara K. Zolbetuximab plus chemotherapy in Japanese patients with claudin 18.2-positive gastric or gastroesophageal junction adenocarcinoma: a combined subgroup analysis of the phase 3 SPOTLIGHT and GLOW trials. Gastric Cancer. 2026 Jul;29(4):777-787. doi: 10.1007/s10120-026-01738-7. Epub 2026 May 7. | |
| 38861294 |
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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 products 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. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.
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.
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.
Participants who met all inclusion criteria and none of the exclusion criteria were enrolled in the study. Randomization was stratified by region (Asia vs Non-Asia), number of organs with metastatic sites (0 to 2 vs ≥ 3) and prior gastrectomy (Yes or No)
Participants with claudin (CLDN)18.2-positive, human epidermal growth factor receptor 2 (HER2) -negative locally advanced unresectable or metastatic gastric and gastroesophageal junction (GEJ) adenocarcinoma
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| ID | Title | Description |
|---|---|---|
| FG000 | CAPOX+ Zolbetuximab | Participants received an intravenous (IV) infusion (as a minimum of 2-hour infusion) of zolbetuximab at a loading dose of 800 milligrams per square meter (mg/m^2) on cycle 1 day 1 (C1D1) followed by subsequent doses of 600 mg/m^2 every 3 weeks starting from C2D1 until participant met study treatment discontinuation criteria. Participants also received up to 8 treatments of capecitabine and oxaliplatin (CAPOX) treatment. Oxaliplatin was administered 130 mg/m^2 IV on day 1 of each cycle over 2 hours for a maximum of 8 treatments; Capecitabine was administered orally at 1000 mg/m^2 twice daily (bid) on days 1 through 14 of each cycle until the participant met study treatment discontinuation criteria. After a maximum of 8 treatments of oxaliplatin, participants may have continued to receive capecitabine taken twice daily on days 1 through 14 of each cycle at the investigator's discretion until the participant met study treatment discontinuation criteria. Each cycle was approximately 21 days. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Dec 6, 2024 | Jul 31, 2025 |
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| oxaliplatin | Drug | Oxaliplatin were administered as a 2-hour IV infusion. |
|
| capecitabine | Drug | Capecitabine were administered orally twice daily (bid). |
|
| placebo | Drug | Placebo were administered as a minimum 2-hour IV infusion. |
|
TTCD: time from randomization to first clinically meaning full deterioration (CMFD) that was confirmed at the next scheduled visit. The EORTC-QLQ-C30 is a 30-item cancer-specific instrument consisting of 5 functional scales (physical, role, emotional, social and cognitive), 9 symptom scales/items (fatigue, nausea/vomiting, general pain, dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties) and a global health status scale. Most items are scored 1 ('not at all') to 4 ('very much') except for the items contributing to the global health status which are scored 1 ('very poor') to 7 ('excellent'). All raw domain scores are linearly transformed to a 0-100 scale with higher scores on symptoms indicate a worse health state. Clinically meaningful deterioration was defined if a participant's change from baseline (CFB) exceeded a pre-specified threshold (as per investigator's discretion) denoting a clinically meaningful change. Kaplan-Meier estimates was used. |
| From the date of randomization until 61 months and 12 days |
| 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 | TTCD:time from randomization to first CMFD confirmed at next scheduled visit.OG25 evaluated gastric & gastroesophageal junction cancer-specific symptoms,had 25 items with 6 scales:dysphagia,eating restrictions,reflux,odynophagia,pain, discomfort,anxiety,and 10 single items:trouble with(taste, swallowing saliva, coughing, talking),eating in front of others,dry mouth,body image,choked when swallowing,weight loss and hair loss. STO22: gastric cancer quality of life questionnaire with 22 questions.For OG25 and STO22,items scored on(1:not at all; 2:a little, 3:quite a bit, 4:very much) and 1 question was "yes or no" for STO22.Linear transformation was used; score ranged from 0 to 100; higher score=better level of functioning or greater degree of symptoms. An item from STO22 instrument related to belching was used with OG25. CMFD: if participant's CFB exceeded pre-specified threshold (per investigator's discretion) denoting a clinically meaningful change. Kaplan-Meier estimates was used | From the date of randomization until 61 months and 12 days |
| Time to Confirmed Deterioration (TTCD) Using Global Health Status as Measured by EORTC QLQ-C30 | TTCD: time from randomization to first CMFD that was confirmed at the next scheduled visit.The EORTC-QLQ-C30 is a 30-item cancer-specific instrument consisting of 5 functional scales (physical, role, emotional, social and cognitive), 9 symptom scales/items (fatigue, nausea/vomiting, general pain, dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties) and a global health status scale. Most items are scored 1 ('not at all') to 4 ('very much') except for the items contributing to the global health status/QoL, which are scored 1 (very poor) to 7 (excellent). All raw domain scores are linearly transformed to a 0-100 scale with higher scores on symptoms indicate a worse health state. Clinically meaningful deterioration was defined if a participant's CFB exceeded a pre-specified threshold (as per investigator's discretion) denoting a clinically meaningful change. Kaplan-Meier estimates was used. | From the date of randomization until 61 months and 12 days |
| Objective Response Rate (ORR) | ORR was defined as the percentage of participants who had best overall response (BOR) of complete response (CR) or partial response (PR) as was assessed by IRC per RECIST 1.1. CR was defined as complete resolution of all attributable clinical symptoms and physical findings. PR was defined as partial resolution of at Least some of the clinical symptoms and physical findings. | From the date of randomization until 61 months and 12 days |
| Duration Of Response (DOR) | DOR was defined as the time from the date of the first response (CR/PR) until the date of PD as assessed by IRC per RECIST 1.1 or date of death from any cause, whichever is earliest.CR was defined as complete resolution of all attributable clinical symptoms and physical findings. PR was defined as partial resolution of at Least some of the clinical symptoms and physical findings. PD was defined as development of new, or progression of existing metastases to the primary cancer under the study. Kaplan-Meier estimates was used. | From first response (CR/PR) until 61 months and 12 days |
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) | An Adverse event (AE) is any untoward medical occurrence in a participant administered a study drug, and which does not have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom or disease (new or exacerbated) temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.TEAE defined as an AE observed after starting administration of the study drug through 30 days after the last dose. | From first dose until 61 months and 12 days |
| Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status | 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. | Baseline, cycle (C) 1 day (D)1 through C60 D1 |
| Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire | The EORTC-QLQ-C30 is a cancer-specific instrument consisting of 5 functional domain scales: physical, role, emotional, social and cognitive.It is a 30-item cancer-specific instrument consisting of 5 functional scales (physical, role, emotional, social and cognitive), 9 symptom scales/items (fatigue, nausea/vomiting, general pain, dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties) and a global health status scale. Most items are scored 1 ('not at all') to 4 ('very much') except for the items contributing to the global health status/QoL, which are scored 1 ('very poor') to 7 ('excellent'). All raw domain scores are linearly transformed to a 0-100 scale with higher scores on symptoms indicate a worse health state. | Baseline, on D1 from C2 through C39, 30-day follow up, 90-day follow up |
| Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire | OG25 evaluated gastric & gastroesophageal junction cancer-specific symptoms,had 25 items with 6 scales:dysphagia,eating restrictions,reflux,odynophagia,pain & discomfort,anxiety,and 10 single items:trouble with(taste, swallowing saliva, coughing, talking),eating in front of others,dry mouth,body image,choked when swallowing,weight loss and hair loss. STO22: gastric cancer quality of life questionnaire with 22 questions.For OG25 and STO22,items scored on(1:not at all; 2:a little, 3:quite a bit, 4:very much) and 1 question was "yes or no" for STO22.Linear transformation was used; score ranged from 0 to 100;higher score=better level of functioning or greater degree of symptoms. An item from STO22 instrument related to belching was used with OG25. | Baseline, on D1 from C2 through C39, 30-day follow up, 90-day follow up |
| Change From Baseline in HRQoL Measured by Global Pain (GP) | The GP instrument is a single assessment of overall pain and participants were assessed in global pain according to the following response categories: 1= no pain (anymore), 2 = less pain, 3 = no change and 4 = more pain. Low pain scores are considered a better outcome than a high pain score. | Baseline, on D1 from C2 through C39, 30-day follow up, 90-day follow up |
| Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire | EQ-5D-5L is a standardized instrument for use as a measure of health outcomes consisting of 6 items that cover 5 main domains (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) and a general visual analog scale for health status. It was developed by the EuroQol Group for use as a generic, preference-based measure of health outcomes. 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. | Baseline, on D1 from C2 through C39, 30-day follow up, 90-day follow up |
| Pharmacokinetics (PK) of Zolbetuximab in Serum: Trough Concentration (Ctrough) | Ctrough was defined as the predose concentration at the end of dosing interval. | Predose on C2D1,C5D1,C9D1,C13D1,C17D1 |
| Number of Anti-drug Antibody (ADA) Positive Participants | Immunogenicity will be measured by the number of participants that are ADA positive. | Predose on C1D1,C2D1,C5D1,C9D1,C13D1,C17D1, 30-day follow up, 90-day Follow up |
| Fairway |
| Kansas |
| 66205 |
| United States |
| Ochsner Clinic CCOP | New Orleans | Louisiana | 70121 | United States |
| New Mexico Oncology Hematology | Albuquerque | New Mexico | 87109 | United States |
| Weill Cornell Medical College (WCMC) | New York | New York | 10021 | United States |
| Montefiore Medical Center (MMC) | The Bronx | New York | 10467 | United States |
| Prisma Health Cancer Institute | Boiling Springs | South Carolina | 29316 | United States |
| Parkland Hospital | Dallas | Texas | 75390 | United States |
| University of Texas Southwestern Medical Center | Dallas | Texas | 75390 | United States |
| Houston Methodist Cancer Center and Institute of Academic Medicine - Oncology | Houston | Texas | 77030 | United States |
| Utah Cancer Specialist | Salt Lake City | Utah | 84106 | United States |
| Site AR54009 | Buenos Aires | Argentina |
| Site GB44005 | Northwood | Argentina |
| Site AR54006 | Pergamino | Argentina |
| Site AR54001 | San Miguel de Tucumán | Argentina |
| Site AR54004 | San Miguel de Tucumán | Argentina |
| Site AR54003 | Viedma | Argentina |
| Site CA15003 | Chicoutimi | Quebec | Canada |
| Site CA15002 | Rimouski | Quebec | Canada |
| Site CA15004 | Calgary | Canada |
| Site CN86034 | Fuzhou | Fujian | China |
| Site CN86037 | Fuzhou | Fujian | China |
| Site CN86032 | Haikou | Hainan | China |
| Site CN86012 | Zhengzhou | Henan | China |
| Site CN86029 | Changsha | Hunan | China |
| Site CN86043 | Hengyang | Hunan | China |
| Site CN86027 | Suzhou | Jiangsu | China |
| Site CN86046 | Wuxi | Jiangsu | China |
| Site CN86007 | Hangzhou | Zhejiang | China |
| Site CN86044 | Baoding | China |
| Site CN86035 | Beijing | China |
| Site CN86050 | Beijing | China |
| Site CN86025 | Bengbu | China |
| Site CN86002 | Changchun | China |
| Site CN86049 | Changchun | China |
| Site CN86053 | Changchun | China |
| Site CN86021 | Changzhou | China |
| Site CN86039 | Chengdu | China |
| Site CN86052 | Dalian | China |
| Site CN86054 | Dalian | China |
| Site CN86015 | Fuzhou | China |
| Site CN86001 | Guangzhou | China |
| Site CN86042 | Guangzhou | China |
| Site CN86051 | Haebrin | China |
| Site CN86036 | Hangzhou | China |
| Site CN86038 | Linyi | China |
| Site CN86016 | Nanjing | China |
| Site CN86045 | Nanning | China |
| Site CN86014 | Shanghai | China |
| Site CN86026 | Shantou | China |
| Site CN86047 | Shenyang | China |
| Site CN86017 | Shijiazhuang | China |
| Site CN86009 | Tianjin | China |
| Site CN86040 | Tianjin | China |
| Site CN86031 | Ürümqi | China |
| Site CN86004 | Wuhan | China |
| Site CN86005 | Wuhan | China |
| Site CN86013 | Xi'an | China |
| Site CN86030 | Xiamen | China |
| Site CN86011 | Xuzhou | China |
| Site CN86024 | Zhengzhou | China |
| Site HR38501 | Varaždin | Croatia |
| Site HR38502 | Zagreb | Croatia |
| Site HR38503 | Zagreb | Croatia |
| Site GR30001 | Athens | Greece |
| Site GR30004 | Heraklion | Greece |
| Site GR30003 | Larissa | Greece |
| Site GR30005 | Neo Faliro, Piraeus | Greece |
| Site GR30007 | Rio Patras | Greece |
| Site GR30002 | Thessaloniki | Greece |
| Site GR3006 | Thessaloniki | Greece |
| Site IE35301 | Dublin | Ireland |
| Site IE35302 | Dublin | Ireland |
| Site JP81007 | Fukuoka | Fukuoka | Japan |
| Site JP81008 | Akashi | Hyōgo | Japan |
| Site JP81003 | Kawasaki | Kanagawa | Japan |
| Site JP81001 | Yokohama | Kanagawa | Japan |
| Site JP81010 | Suita | Osaka | Japan |
| Site JP81005 | Utsunomiya | Tochigi | Japan |
| Site JP81002 | Chiba | Japan |
| Site JP81006 | Kashiwa | Japan |
| Site JP81004 | Kita-gun | Japan |
| Site JP81012 | Kōtoku | Japan |
| Site JP81009 | Matsuyama | Japan |
| Site JP81011 | Tsukiji | Japan |
| Site MY60001 | George Town | Malaysia |
| Site MY60004 | Kota Kinabalu | Malaysia |
| Site MY60002 | Kuala Lumpur | Malaysia |
| Site MY60003 | Kuala Lumpur | Malaysia |
| Site MY60005 | Kuala Lumpur | Malaysia |
| Site NL31004 | Groningen | Netherlands |
| Site NL31003 | Tilburg | Netherlands |
| Site PT35109 | Braga | Portugal |
| Site PT35110 | Coimbra | Portugal |
| Site PT35111 | Guimarães | Portugal |
| Site PT35102 | Lisbon | Portugal |
| Site PT35106 | Lisbon | Portugal |
| Site PT35105 | Porto | Portugal |
| Site PT35108 | Porto | Portugal |
| Site PT35104 | Santa Maria da Feira | Portugal |
| Site PT35101 | Setúbal | Portugal |
| Site PT35107 | Vila Real | Portugal |
| Site RO40002 | Bucharest | Romania |
| Site RO40005 | Cluj-Napoca | Romania |
| Site RO40007 | Cluj-Napoca | Romania |
| Site RO40003 | Craiova | Romania |
| Site RO40004 | Floreşti | Romania |
| Site RO40001 | Iași | Romania |
| Site RO40006 | Iași | Romania |
| Site RO40008 | Timișoara | Romania |
| Site KR82002 | Daegu | South Korea |
| Site KR82006 | Goyang-si | South Korea |
| Site KR82007 | Gyeonggi-do | South Korea |
| Site KR82014 | Incheon | South Korea |
| Site KR82008 | Jeollanam-do | South Korea |
| Site KR82010 | Jeonju | South Korea |
| Site KR82011 | Seongnam-si | South Korea |
| Site KR82001 | Seoul | South Korea |
| Site KR82003 | Seoul | South Korea |
| Site KR82012 | Seoul | South Korea |
| Site KR82013 | Seoul | South Korea |
| Site KR82015 | Seoul | South Korea |
| Site KR82009 | Suwon | South Korea |
| Site ES34005 | A Coruña | Spain |
| Site ES34006 | Barcelona | Spain |
| Site ES34009 | Barcelona | Spain |
| Site ES34010 | Barcelona | Spain |
| Site ES34001 | Elche | Spain |
| Site ES34002 | Madrid | Spain |
| Site ES34003 | Madrid | Spain |
| Site ES34008 | Madrid | Spain |
| Site ES34013 | Madrid | Spain |
| Site ES34011 | Málaga | Spain |
| Site ES34004 | Pamplona | Spain |
| Site ES34007 | Valencia | Spain |
| Site ES34012 | Valencia | Spain |
| Site TW88602 | Kaohsiung City | Taiwan |
| Site TW88603 | Taichung | Taiwan |
| Site TW88604 | Taipei | Taiwan |
| Site TW88605 | Tianan | Taiwan |
| Site TH66002 | Bangkok | Thailand |
| Site TH66005 | Bangkok | Thailand |
| Site TH66007 | Bangkok | Thailand |
| Site TH66009 | Bangkok | Thailand |
| Site TH66011 | Laksi | Thailand |
| Site TH66001 | Muang | Thailand |
| Site TH66003 | Muang | Thailand |
| Site TH66006 | Pathum Thani | Thailand |
| Site TH66010 | Pathumwan | Thailand |
| Site TH66004 | Songkhla | Thailand |
| Site TH66008 | Vadhana | Thailand |
| Site TR90008 | Pendik | Istanbul | Turkey (Türkiye) |
| Site TR90003 | Atakum | Turkey (Türkiye) |
| Site TR90004 | Balcalı | Turkey (Türkiye) |
| Site TR90012 | Bornova | Turkey (Türkiye) |
| Site TR90001 | Bursa | Turkey (Türkiye) |
| Site TR90002 | Istanbul | Turkey (Türkiye) |
| Site TR90010 | Istanbul | Turkey (Türkiye) |
| Site TR90015 | Istanbul | Turkey (Türkiye) |
| Site TR90007 | Konya | Turkey (Türkiye) |
| Site TR90013 | Konyaalti | Turkey (Türkiye) |
| Site TR90011 | Malatya | Turkey (Türkiye) |
| Site GB44002 | Bristol | United Kingdom |
| Site GB44004 | Cardiff | United Kingdom |
| Site GB44001 | London | United Kingdom |
| Derived |
| Shitara K, Shah MA, Lordick F, Bang YJ, Ilson D, Van Cutsem E, Enzinger P, Kim SS, Klempner SJ, Moran D, Park JW, Bhattacharya P, Ajani JA, Xu RH. Zolbetuximab plus chemotherapy for locally advanced unresectable or metastatic stomach or gastroesophageal junction cancers: a plain language summary. Future Oncol. 2024;20(26):1861-1877. doi: 10.1080/14796694.2024.2342107. Epub 2024 May 24. |
| 37524953 | Derived | Shah MA, Shitara K, Ajani JA, Bang YJ, Enzinger P, Ilson D, Lordick F, Van Cutsem E, Gallego Plazas J, Huang J, Shen L, Oh SC, Sunpaweravong P, Soo Hoo HF, Turk HM, Oh M, Park JW, Moran D, Bhattacharya P, Arozullah A, Xu RH. Zolbetuximab plus CAPOX in CLDN18.2-positive gastric or gastroesophageal junction adenocarcinoma: the randomized, phase 3 GLOW trial. Nat Med. 2023 Aug;29(8):2133-2141. doi: 10.1038/s41591-023-02465-7. Epub 2023 Jul 31. |
| FG001 | CAPOX+ Placebo | Participants received an IV infusion (as a minimum of 2-hour infusion) of placebo matched to zolbetuximab on C1D1 followed by subsequent doses every 3 weeks starting from C2D1 until participant met study treatment discontinuation criteria. Participants also received up to 8 treatments of CAPOX. Oxaliplatin was administered 130 mg/m^2 IV on day 1 of each cycle over 2 hours for a maximum of 8 treatments; Capecitabine was administered orally at 1000 mg/m^2 bid on days 1 through 14 of each cycle until the participant met study treatment discontinuation criteria. After a maximum of 8 treatments of oxaliplatin, participants may have continued to receive capecitabine taken twice daily on days 1 through 14 of each cycle at the investigator's discretion until the participant met study treatment discontinuation criteria. Each cycle was approximately 21 days. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Full analysis set (FAS) included all participants who were randomized to 1 of the treatment arms.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | CAPOX+ Zolbetuximab | Participants received an intravenous (IV) infusion (as a minimum of 2-hour infusion) of zolbetuximab at a loading dose of 800 milligrams per square meter (mg/m^2) on cycle 1 day 1 (C1D1) followed by subsequent doses of 600 mg/m^2 every 3 weeks starting from C2D1 until participant met study treatment discontinuation criteria. Participants also received up to 8 treatments of capecitabine and oxaliplatin (CAPOX) treatment. Oxaliplatin was administered 130 mg/m^2 IV on day 1 of each cycle over 2 hours for a maximum of 8 treatments; Capecitabine was administered orally at 1000 mg/m^2 twice daily (bid) on days 1 through 14 of each cycle until the participant met study treatment discontinuation criteria. After a maximum of 8 treatments of oxaliplatin, participants may have continued to receive capecitabine taken twice daily on days 1 through 14 of each cycle at the investigator's discretion until the participant met study treatment discontinuation criteria. Each cycle was approximately 21 days. |
| BG001 | CAPOX+ Placebo | Participants received an IV infusion (as a minimum of 2-hour infusion) of placebo matched to zolbetuximab on C1D1 followed by subsequent doses every 3 weeks starting from C2D1 until participant met study treatment discontinuation criteria. Participants also received up to 8 treatments of CAPOX. Oxaliplatin was administered 130 mg/m^2 IV on day 1 of each cycle over 2 hours for a maximum of 8 treatments; Capecitabine was administered orally at 1000 mg/m^2 bid on days 1 through 14 of each cycle until the participant met study treatment discontinuation criteria. After a maximum of 8 treatments of oxaliplatin, participants may have continued to receive capecitabine taken twice daily on days 1 through 14 of each cycle at the investigator's discretion until the participant met study treatment discontinuation criteria. Each cycle was approximately 21 days. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region (Asia vs Non-Asia) | Number | Participants |
| ||||||||||||||||
| Number of organs with metastatic sites | Number | Participants |
| ||||||||||||||||
| Prior Gastrectomy | Number | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Progression Free Survival (PFS) | PFS was defined as the time from the date of randomization until the date of radiological progressive disease (PD) (per Response Evaluation Criteria in Solid Tumors [RECIST] 1.1 by independent review committee [IRC]) or death from any cause, whichever was earliest. PD was defined as development of new, or progression of existing metastases to the primary cancer under the study. Kaplan-Meier estimates was used. | FAS | Posted | Median | 95% Confidence Interval | Months | From the date of randomization until 61 months and 12 days |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Overall Survival (OS) | OS was defined as the time from the date of randomization until the date of death from any cause. Kaplan-Meier estimates was used. | FAS | Posted | Median | 95% Confidence Interval | Months | From the date of randomization until 61 months and 12 days |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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) | TTCD: time from randomization to first clinically meaning full deterioration (CMFD) that was confirmed at the next scheduled visit. The EORTC-QLQ-C30 is a 30-item cancer-specific instrument consisting of 5 functional scales (physical, role, emotional, social and cognitive), 9 symptom scales/items (fatigue, nausea/vomiting, general pain, dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties) and a global health status scale. Most items are scored 1 ('not at all') to 4 ('very much') except for the items contributing to the global health status which are scored 1 ('very poor') to 7 ('excellent'). All raw domain scores are linearly transformed to a 0-100 scale with higher scores on symptoms indicate a worse health state. Clinically meaningful deterioration was defined if a participant's change from baseline (CFB) exceeded a pre-specified threshold (as per investigator's discretion) denoting a clinically meaningful change. Kaplan-Meier estimates was used. | FAS | Posted | Median | 95% Confidence Interval | Months | From the date of randomization until 61 months and 12 days |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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 | TTCD:time from randomization to first CMFD confirmed at next scheduled visit.OG25 evaluated gastric & gastroesophageal junction cancer-specific symptoms,had 25 items with 6 scales:dysphagia,eating restrictions,reflux,odynophagia,pain, discomfort,anxiety,and 10 single items:trouble with(taste, swallowing saliva, coughing, talking),eating in front of others,dry mouth,body image,choked when swallowing,weight loss and hair loss. STO22: gastric cancer quality of life questionnaire with 22 questions.For OG25 and STO22,items scored on(1:not at all; 2:a little, 3:quite a bit, 4:very much) and 1 question was "yes or no" for STO22.Linear transformation was used; score ranged from 0 to 100; higher score=better level of functioning or greater degree of symptoms. An item from STO22 instrument related to belching was used with OG25. CMFD: if participant's CFB exceeded pre-specified threshold (per investigator's discretion) denoting a clinically meaningful change. Kaplan-Meier estimates was used | FAS | Posted | Median | 95% Confidence Interval | Months | From the date of randomization until 61 months and 12 days |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time to Confirmed Deterioration (TTCD) Using Global Health Status as Measured by EORTC QLQ-C30 | TTCD: time from randomization to first CMFD that was confirmed at the next scheduled visit.The EORTC-QLQ-C30 is a 30-item cancer-specific instrument consisting of 5 functional scales (physical, role, emotional, social and cognitive), 9 symptom scales/items (fatigue, nausea/vomiting, general pain, dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties) and a global health status scale. Most items are scored 1 ('not at all') to 4 ('very much') except for the items contributing to the global health status/QoL, which are scored 1 (very poor) to 7 (excellent). All raw domain scores are linearly transformed to a 0-100 scale with higher scores on symptoms indicate a worse health state. Clinically meaningful deterioration was defined if a participant's CFB exceeded a pre-specified threshold (as per investigator's discretion) denoting a clinically meaningful change. Kaplan-Meier estimates was used. | FAS | Posted | Median | 95% Confidence Interval | Months | From the date of randomization until 61 months and 12 days |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Objective Response Rate (ORR) | ORR was defined as the percentage of participants who had best overall response (BOR) of complete response (CR) or partial response (PR) as was assessed by IRC per RECIST 1.1. CR was defined as complete resolution of all attributable clinical symptoms and physical findings. PR was defined as partial resolution of at Least some of the clinical symptoms and physical findings. | FAS | Posted | Number | 95% Confidence Interval | Percentage of Participants | From the date of randomization until 61 months and 12 days |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Duration Of Response (DOR) | DOR was defined as the time from the date of the first response (CR/PR) until the date of PD as assessed by IRC per RECIST 1.1 or date of death from any cause, whichever is earliest.CR was defined as complete resolution of all attributable clinical symptoms and physical findings. PR was defined as partial resolution of at Least some of the clinical symptoms and physical findings. PD was defined as development of new, or progression of existing metastases to the primary cancer under the study. Kaplan-Meier estimates was used. | FAS- All Objective Responders | Posted | Median | 95% Confidence Interval | Months | From first response (CR/PR) until 61 months and 12 days |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Treatment Emergent Adverse Events (TEAEs) | An Adverse event (AE) is any untoward medical occurrence in a participant administered a study drug, and which does not have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom or disease (new or exacerbated) temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.TEAE defined as an AE observed after starting administration of the study drug through 30 days after the last dose. | FAS | Posted | Number | Participants | From first dose until 61 months and 12 days |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participant With Eastern Cooperative Oncology Group (ECOG) Performance Status | 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. | FAS | Posted | Number | Participants | Baseline, cycle (C) 1 day (D)1 through C60 D1 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire | The EORTC-QLQ-C30 is a cancer-specific instrument consisting of 5 functional domain scales: physical, role, emotional, social and cognitive.It is a 30-item cancer-specific instrument consisting of 5 functional scales (physical, role, emotional, social and cognitive), 9 symptom scales/items (fatigue, nausea/vomiting, general pain, dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties) and a global health status scale. Most items are scored 1 ('not at all') to 4 ('very much') except for the items contributing to the global health status/QoL, which are scored 1 ('very poor') to 7 ('excellent'). All raw domain scores are linearly transformed to a 0-100 scale with higher scores on symptoms indicate a worse health state. | FAS with available data was analyzed. | Posted | Mean | Standard Deviation | Unit on a scale | Baseline, on D1 from C2 through C39, 30-day follow up, 90-day follow up |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire Plus STO22 Belching Subscale Questionnaire | OG25 evaluated gastric & gastroesophageal junction cancer-specific symptoms,had 25 items with 6 scales:dysphagia,eating restrictions,reflux,odynophagia,pain & discomfort,anxiety,and 10 single items:trouble with(taste, swallowing saliva, coughing, talking),eating in front of others,dry mouth,body image,choked when swallowing,weight loss and hair loss. STO22: gastric cancer quality of life questionnaire with 22 questions.For OG25 and STO22,items scored on(1:not at all; 2:a little, 3:quite a bit, 4:very much) and 1 question was "yes or no" for STO22.Linear transformation was used; score ranged from 0 to 100;higher score=better level of functioning or greater degree of symptoms. An item from STO22 instrument related to belching was used with OG25. | FAS with available data was analyzed. | Posted | Mean | Standard Deviation | Unit on a scale | Baseline, on D1 from C2 through C39, 30-day follow up, 90-day follow up |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in HRQoL Measured by Global Pain (GP) | The GP instrument is a single assessment of overall pain and participants were assessed in global pain according to the following response categories: 1= no pain (anymore), 2 = less pain, 3 = no change and 4 = more pain. Low pain scores are considered a better outcome than a high pain score. | FAS with available data was analyzed. | Posted | Mean | Standard Deviation | Unit on a scale | Baseline, on D1 from C2 through C39, 30-day follow up, 90-day follow up |
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| Secondary | Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire | EQ-5D-5L is a standardized instrument for use as a measure of health outcomes consisting of 6 items that cover 5 main domains (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) and a general visual analog scale for health status. It was developed by the EuroQol Group for use as a generic, preference-based measure of health outcomes. 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. | FAS with available data was analyzed. | Posted | Mean | Standard Deviation | Unit on a scale | Baseline, on D1 from C2 through C39, 30-day follow up, 90-day follow up |
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| Secondary | Pharmacokinetics (PK) of Zolbetuximab in Serum: Trough Concentration (Ctrough) | Ctrough was defined as the predose concentration at the end of dosing interval. | Pharmakokinetic analysis set (PKAS) consisted of the subset of the SAF for which at least 1 zolbetuximab concentration measurement was available. Participants with available data at each timepoint were analyzed. | Posted | Mean | Standard Deviation | micrograms/mililiter (ug/mL) | Predose on C2D1,C5D1,C9D1,C13D1,C17D1 |
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| Secondary | Number of Anti-drug Antibody (ADA) Positive Participants | Immunogenicity will be measured by the number of participants that are ADA positive. | Participants who were Randomized to Zolbetuximab + CAPOX Arm with at least One Valid Result for ADA | Posted | Number | Participants | Predose on C1D1,C2D1,C5D1,C9D1,C13D1,C17D1, 30-day follow up, 90-day Follow up |
|
|
All-cause mortality- From the start of randomization up to 61 months and 12 days Serious and non serious adverse events- From first dose up to 61 months and 12 days
SAF. Participants may have repeated in the arm groups.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Zolbetuximab | Participants received an IV infusion (as a minimum of 2-hour infusion) of zolbetuximab at a loading dose of 800 mg/m^2 on C1D1 followed by subsequent doses of 600 mg/m^2 every 3 weeks starting from C2D1 until participant met study treatment discontinuation criteria. Each cycle was approximately 21 days. | 180 | 254 | 123 | 254 | 249 | 254 |
| EG001 | Capecitabine | Participants received capecitabine orally at 1000 mg/m^2 (bid) on days 1 through 14 of each cycle until the participant met study treatment discontinuation criteria. After a maximum of 8 treatments of oxaliplatin, participants may have continued to receive capecitabine taken twice daily on days 1 through 14 of each cycle at the investigator's discretion until the participant met study treatment discontinuation criteria. Each cycle was approximately 21 days. | 387 | 503 | 249 | 503 | 481 | 503 |
| EG002 | Oxaliplatin | Participants received an IV infusion of oxaliplatin 130 mg/m^2 on day 1 of each cycle over 2 hours for a maximum of 8 treatments. Each cycle was approximately 21 days. | 387 | 503 | 249 | 503 | 481 | 503 |
| EG003 | Placebo | Participants received an IV infusion (as a minimum of 2-hour infusion) of placebo matched to zolbetuximab on C1D1 followed by subsequent doses every 3 weeks starting from C2D1 until participant met study treatment discontinuation criteria. Each cycle was approximately 21 days. | 207 | 249 | 126 | 249 | 232 | 249 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Agranulocytosis | Blood and lymphatic system disorders | MedDRA v25 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA v25 | Systematic Assessment |
| |
| Bone marrow infiltration | Blood and lymphatic system disorders | MedDRA v25 | Systematic Assessment |
| |
| Disseminated intravascular coagulation | Blood and lymphatic system disorders | MedDRA v25 | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA v25 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA v25 | Systematic Assessment |
| |
| Microangiopathic haemolytic anaemia | Blood and lymphatic system disorders | MedDRA v25 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA v25 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA v25 | Systematic Assessment |
| |
| Acute coronary syndrome | Cardiac disorders | MedDRA v25 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA v25 | Systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA v25 | Systematic Assessment |
| |
| Cardio-respiratory arrest | Cardiac disorders | MedDRA v25 | Systematic Assessment |
| |
| Coronary artery occlusion | Cardiac disorders | MedDRA v25 | Systematic Assessment |
| |
| Sinus bradycardia | Cardiac disorders | MedDRA v25 | Systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA v25 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA v25 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA v25 | Systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | MedDRA v25 | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA v25 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA v25 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA v25 | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA v25 | Systematic Assessment |
| |
| Enteritis | Gastrointestinal disorders | MedDRA v25 | Systematic Assessment |
| |
| Enterocolitis | Gastrointestinal disorders | MedDRA v25 | Systematic Assessment |
| |
| Gastric haemorrhage | Gastrointestinal disorders | MedDRA v25 | Systematic Assessment |
| |
| Gastric perforation | Gastrointestinal disorders | MedDRA v25 | Systematic Assessment |
| |
| Gastric stenosis | Gastrointestinal disorders | MedDRA v25 | Systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA v25 | Systematic Assessment |
| |
| Gingival bleeding | Gastrointestinal disorders | MedDRA v25 | Systematic Assessment |
| |
| Haematemesis | Gastrointestinal disorders | MedDRA v25 | Systematic Assessment |
| |
| Haemorrhagic ascites | Gastrointestinal disorders | MedDRA v25 | Systematic Assessment |
| |
| Haemorrhoidal haemorrhage | Gastrointestinal disorders | MedDRA v25 | Systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | MedDRA v25 | Systematic Assessment |
| |
| Impaired gastric emptying | Gastrointestinal disorders | MedDRA v25 | Systematic Assessment |
| |
| Intestinal obstruction | Gastrointestinal disorders | MedDRA v25 | Systematic Assessment |
| |
| Intra-abdominal haemorrhage | Gastrointestinal disorders | MedDRA v25 | Systematic Assessment |
| |
| Large intestinal obstruction | Gastrointestinal disorders | MedDRA v25 | Systematic Assessment |
| |
| Mouth ulceration | Gastrointestinal disorders | MedDRA v25 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA v25 | Systematic Assessment |
| |
| Obstruction gastric | Gastrointestinal disorders | MedDRA v25 | Systematic Assessment |
| |
| Oesophageal obstruction | Gastrointestinal disorders | MedDRA v25 | Systematic Assessment |
| |
| Oesophageal stenosis | Gastrointestinal disorders | MedDRA v25 | Systematic Assessment |
| |
| Oesophageal ulcer | Gastrointestinal disorders | MedDRA v25 | Systematic Assessment |
| |
| Oesophageal-pulmonary fistula | Gastrointestinal disorders | MedDRA v25 | Systematic Assessment |
| |
| Pancreatic disorder | Gastrointestinal disorders | MedDRA v25 | Systematic Assessment |
| |
| Subileus | Gastrointestinal disorders | MedDRA v25 | Systematic Assessment |
| |
| Swollen tongue | Gastrointestinal disorders | MedDRA v25 | Systematic Assessment |
| |
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA v25 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA v25 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA v25 | Systematic Assessment |
| |
| Death | General disorders | MedDRA v25 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA v25 | Systematic Assessment |
| |
| Gait inability | General disorders | MedDRA v25 | Systematic Assessment |
| |
| Gravitational oedema | General disorders | MedDRA v25 | Systematic Assessment |
| |
| Incarcerated hernia | General disorders | MedDRA v25 | Systematic Assessment |
| |
| Infusion site extravasation | General disorders | MedDRA v25 | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA v25 | Systematic Assessment |
| |
| Mucosal inflammation | General disorders | MedDRA v25 | Systematic Assessment |
| |
| Multiple organ dysfunction syndrome | General disorders | MedDRA v25 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA v25 | Systematic Assessment |
| |
| Performance status decreased | General disorders | MedDRA v25 | Systematic Assessment |
| |
| Peripheral swelling | General disorders | MedDRA v25 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA v25 | Systematic Assessment |
| |
| Sudden death | General disorders | MedDRA v25 | Systematic Assessment |
| |
| Bile duct stenosis | Hepatobiliary disorders | MedDRA v25 | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA v25 | Systematic Assessment |
| |
| Deficiency of bile secretion | Hepatobiliary disorders | MedDRA v25 | Systematic Assessment |
| |
| Drug-induced liver injury | Hepatobiliary disorders | MedDRA v25 | Systematic Assessment |
| |
| Hepatic failure | Hepatobiliary disorders | MedDRA v25 | Systematic Assessment |
| |
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA v25 | Systematic Assessment |
| |
| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA v25 | Systematic Assessment |
| |
| Hypertransaminasaemia | Hepatobiliary disorders | MedDRA v25 | Systematic Assessment |
| |
| Jaundice | Hepatobiliary disorders | MedDRA v25 | Systematic Assessment |
| |
| Jaundice cholestatic | Hepatobiliary disorders | MedDRA v25 | Systematic Assessment |
| |
| Liver injury | Hepatobiliary disorders | MedDRA v25 | Systematic Assessment |
| |
| Anaphylactic reaction | Immune system disorders | MedDRA v25 | Systematic Assessment |
| |
| Drug hypersensitivity | Immune system disorders | MedDRA v25 | Systematic Assessment |
| |
| Abdominal infection | Infections and infestations | MedDRA v25 | Systematic Assessment |
| |
| Abdominal sepsis | Infections and infestations | MedDRA v25 | Systematic Assessment |
| |
| Bacteraemia | Infections and infestations | MedDRA v25 | Systematic Assessment |
| |
| Bacterial infection | Infections and infestations | MedDRA v25 | Systematic Assessment |
| |
| Biliary tract infection | Infections and infestations | MedDRA v25 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA v25 | Systematic Assessment |
| |
| Device related infection | Infections and infestations | MedDRA v25 | Systematic Assessment |
| |
| Escherichia infection | Infections and infestations | MedDRA v25 | Systematic Assessment |
| |
| Escherichia urinary tract infection | Infections and infestations | MedDRA v25 | Systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA v25 | Systematic Assessment |
| |
| Klebsiella sepsis | Infections and infestations | MedDRA v25 | Systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA v25 | Systematic Assessment |
| |
| Lower respiratory tract infection viral | Infections and infestations | MedDRA v25 | Systematic Assessment |
| |
| Mucosal infection | Infections and infestations | MedDRA v25 | Systematic Assessment |
| |
| Neutropenic sepsis | Infections and infestations | MedDRA v25 | Systematic Assessment |
| |
| Peritonitis | Infections and infestations | MedDRA v25 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA v25 | Systematic Assessment |
| |
| Pneumonia aspiration | Infections and infestations | MedDRA v25 | Systematic Assessment |
| |
| Pneumonia respiratory syncytial viral | Infections and infestations | MedDRA v25 | Systematic Assessment |
| |
| Pyelonephritis acute | Infections and infestations | MedDRA v25 | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA v25 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA v25 | Systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA v25 | Systematic Assessment |
| |
| Spontaneous bacterial peritonitis | Infections and infestations | MedDRA v25 | Systematic Assessment |
| |
| Subcutaneous abscess | Infections and infestations | MedDRA v25 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA v25 | Systematic Assessment |
| |
| Urinary tract infection bacterial | Infections and infestations | MedDRA v25 | Systematic Assessment |
| |
| Wound infection | Infections and infestations | MedDRA v25 | Systematic Assessment |
| |
| Clavicle fracture | Injury, poisoning and procedural complications | MedDRA v25 | Systematic Assessment |
| |
| Craniocerebral injury | Injury, poisoning and procedural complications | MedDRA v25 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA v25 | Systematic Assessment |
| |
| Femoral neck fracture | Injury, poisoning and procedural complications | MedDRA v25 | Systematic Assessment |
| |
| Femur fracture | Injury, poisoning and procedural complications | MedDRA v25 | Systematic Assessment |
| |
| Gastrointestinal anastomotic leak | Injury, poisoning and procedural complications | MedDRA v25 | Systematic Assessment |
| |
| Head injury | Injury, poisoning and procedural complications | MedDRA v25 | Systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA v25 | Systematic Assessment |
| |
| Procedural complication | Injury, poisoning and procedural complications | MedDRA v25 | Systematic Assessment |
| |
| Road traffic accident | Injury, poisoning and procedural complications | MedDRA v25 | Systematic Assessment |
| |
| Skin abrasion | Injury, poisoning and procedural complications | MedDRA v25 | Systematic Assessment |
| |
| Stoma prolapse | Injury, poisoning and procedural complications | MedDRA v25 | Systematic Assessment |
| |
| Wound complication | Injury, poisoning and procedural complications | MedDRA v25 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA v25 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA v25 | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA v25 | Systematic Assessment |
| |
| Electrocardiogram QT prolonged | Investigations | MedDRA v25 | Systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | MedDRA v25 | Systematic Assessment |
| |
| International normalised ratio increased | Investigations | MedDRA v25 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA v25 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA v25 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA v25 | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA v25 | Systematic Assessment |
| |
| Acidosis | Metabolism and nutrition disorders | MedDRA v25 | Systematic Assessment |
| |
| Alkalosis | Metabolism and nutrition disorders | MedDRA v25 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA v25 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA v25 | Systematic Assessment |
| |
| Electrolyte imbalance | Metabolism and nutrition disorders | MedDRA v25 | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA v25 | Systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA v25 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA v25 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA v25 | Systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA v25 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA v25 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA v25 | Systematic Assessment |
| |
| Myositis | Musculoskeletal and connective tissue disorders | MedDRA v25 | Systematic Assessment |
| |
| Benign breast neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v25 | Systematic Assessment |
| |
| Malignant neoplasm progression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v25 | Systematic Assessment |
| |
| Metastases to meninges | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v25 | Systematic Assessment |
| |
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v25 | Systematic Assessment |
| |
| Tumour haemorrhage | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v25 | Systematic Assessment |
| |
| Cerebral haemorrhage | Nervous system disorders | MedDRA v25 | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA v25 | Systematic Assessment |
| |
| Dysarthria | Nervous system disorders | MedDRA v25 | Systematic Assessment |
| |
| Epilepsy | Nervous system disorders | MedDRA v25 | Systematic Assessment |
| |
| Intracranial pressure increased | Nervous system disorders | MedDRA v25 | Systematic Assessment |
| |
| Lethargy | Nervous system disorders | MedDRA v25 | Systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MedDRA v25 | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA v25 | Systematic Assessment |
| |
| Paraparesis | Nervous system disorders | MedDRA v25 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA v25 | Systematic Assessment |
| |
| Device occlusion | Product Issues | MedDRA v25 | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA v25 | Systematic Assessment |
| |
| Delirium | Psychiatric disorders | MedDRA v25 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA v25 | Systematic Assessment |
| |
| Choluria | Renal and urinary disorders | MedDRA v25 | Systematic Assessment |
| |
| Hydronephrosis | Renal and urinary disorders | MedDRA v25 | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA v25 | Systematic Assessment |
| |
| Renal impairment | Renal and urinary disorders | MedDRA v25 | Systematic Assessment |
| |
| Ureteric obstruction | Renal and urinary disorders | MedDRA v25 | Systematic Assessment |
| |
| Urinary tract obstruction | Renal and urinary disorders | MedDRA v25 | Systematic Assessment |
| |
| Pelvic haematoma | Reproductive system and breast disorders | MedDRA v25 | Systematic Assessment |
| |
| Acute respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA v25 | Systematic Assessment |
| |
| Dysaesthesia pharynx | Respiratory, thoracic and mediastinal disorders | MedDRA v25 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA v25 | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA v25 | Systematic Assessment |
| |
| Laryngospasm | Respiratory, thoracic and mediastinal disorders | MedDRA v25 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA v25 | Systematic Assessment |
| |
| Pleurisy | Respiratory, thoracic and mediastinal disorders | MedDRA v25 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA v25 | Systematic Assessment |
| |
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA v25 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA v25 | Systematic Assessment |
| |
| Cutaneous vasculitis | Skin and subcutaneous tissue disorders | MedDRA v25 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA v25 | Systematic Assessment |
| |
| Skin necrosis | Skin and subcutaneous tissue disorders | MedDRA v25 | Systematic Assessment |
| |
| Skin toxicity | Skin and subcutaneous tissue disorders | MedDRA v25 | Systematic Assessment |
| |
| Embolism | Vascular disorders | MedDRA v25 | Systematic Assessment |
| |
| Embolism venous | Vascular disorders | MedDRA v25 | Systematic Assessment |
| |
| Flushing | Vascular disorders | MedDRA v25 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA v25 | Systematic Assessment |
| |
| Venous thrombosis | Vascular disorders | MedDRA v25 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA v25 | Systematic Assessment |
| |
| COVID-19 pneumonia | Infections and infestations | MedDRA v25 | Systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA v25 | Systematic Assessment |
| |
| Pulmonary artery thrombosis | Respiratory, thoracic and mediastinal disorders | MedDRA v25 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA v25 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA v25 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA v25 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA v25 | Systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA v25 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA v25 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA v25 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA v25 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA v25 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA v25 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA v25 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA v25 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA v25 | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA v25 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA v25 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA v25 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA v25 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA v25 | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA v25 | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA v25 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA v25 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA v25 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA v25 | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA v25 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA v25 | Systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA v25 | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA v25 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA v25 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA v25 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA v25 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA v25 | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA v25 | Systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA v25 | Systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MedDRA v25 | Systematic Assessment |
| |
| Neurotoxicity | Nervous system disorders | MedDRA v25 | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA v25 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA v25 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA v25 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA v25 | Systematic Assessment |
| |
| Palmar-plantar erythrodysaesthesia syndrome | Skin and subcutaneous tissue disorders | MedDRA v25 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA v25 | Systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | MedDRA v25 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA v25 | Systematic Assessment |
|
Institute and/or Principal Investigator may publish trial data generated at their specific study site after Sponsor publication of the multi-center data. Sponsor must receive a site's manuscript prior to publication for review and comment as specified in the Investigator Agreement.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Transparency | Astellas Pharma Global Development, Inc | 8008887704 | astellas.resultsdisclosure@astellas.com |
| Prot_002.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 20, 2023 | Nov 13, 2024 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D009369 | Neoplasms |
| D013274 | Stomach Neoplasms |
| ID | Term |
|---|---|
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C585662 | zolbetuximab |
| D000077150 | Oxaliplatin |
| D000069287 | Capecitabine |
| ID | Term |
|---|---|
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D005472 | Fluorouracil |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Non-Asia |
|
| >=3 metastatic sites |
|
| No |
|
|
|
|
| OG001 | CAPOX+ Placebo | Participants received an IV infusion (as a minimum of 2-hour infusion) of placebo matched to zolbetuximab on C1D1 followed by subsequent doses every 3 weeks starting from C2D1 until participant met study treatment discontinuation criteria. Participants also received up to 8 treatments of CAPOX. Oxaliplatin was administered 130 mg/m^2 IV on day 1 of each cycle over 2 hours for a maximum of 8 treatments; Capecitabine was administered orally at 1000 mg/m^2 bid on days 1 through 14 of each cycle until the participant met study treatment discontinuation criteria. After a maximum of 8 treatments of oxaliplatin, participants may have continued to receive capecitabine taken twice daily on days 1 through 14 of each cycle at the investigator's discretion until the participant met study treatment discontinuation criteria. Each cycle was approximately 21 days. |
|
|
|
| OG001 | CAPOX+ Placebo | Participants received an IV infusion (as a minimum of 2-hour infusion) of placebo matched to zolbetuximab on C1D1 followed by subsequent doses every 3 weeks starting from C2D1 until participant met study treatment discontinuation criteria. Participants also received up to 8 treatments of CAPOX. Oxaliplatin was administered 130 mg/m^2 IV on day 1 of each cycle over 2 hours for a maximum of 8 treatments; Capecitabine was administered orally at 1000 mg/m^2 bid on days 1 through 14 of each cycle until the participant met study treatment discontinuation criteria. After a maximum of 8 treatments of oxaliplatin, participants may have continued to receive capecitabine taken twice daily on days 1 through 14 of each cycle at the investigator's discretion until the participant met study treatment discontinuation criteria. Each cycle was approximately 21 days. |
|
|
|
| OG001 | CAPOX+ Placebo | Participants received an IV infusion (as a minimum of 2-hour infusion) of placebo matched to zolbetuximab on C1D1 followed by subsequent doses every 3 weeks starting from C2D1 until participant met study treatment discontinuation criteria. Participants also received up to 8 treatments of CAPOX. Oxaliplatin was administered 130 mg/m^2 IV on day 1 of each cycle over 2 hours for a maximum of 8 treatments; Capecitabine was administered orally at 1000 mg/m^2 bid on days 1 through 14 of each cycle until the participant met study treatment discontinuation criteria. After a maximum of 8 treatments of oxaliplatin, participants may have continued to receive capecitabine taken twice daily on days 1 through 14 of each cycle at the investigator's discretion until the participant met study treatment discontinuation criteria. Each cycle was approximately 21 days. |
|
|
|
| CAPOX+ Placebo |
Participants received an IV infusion (as a minimum of 2-hour infusion) of placebo matched to zolbetuximab on C1D1 followed by subsequent doses every 3 weeks starting from C2D1 until participant met study treatment discontinuation criteria. Participants also received up to 8 treatments of CAPOX. Oxaliplatin was administered 130 mg/m^2 IV on day 1 of each cycle over 2 hours for a maximum of 8 treatments; Capecitabine was administered orally at 1000 mg/m^2 bid on days 1 through 14 of each cycle until the participant met study treatment discontinuation criteria. After a maximum of 8 treatments of oxaliplatin, participants may have continued to receive capecitabine taken twice daily on days 1 through 14 of each cycle at the investigator's discretion until the participant met study treatment discontinuation criteria. Each cycle was approximately 21 days. |
|
|
|
| OG001 | CAPOX+ Placebo | Participants received an IV infusion (as a minimum of 2-hour infusion) of placebo matched to zolbetuximab on C1D1 followed by subsequent doses every 3 weeks starting from C2D1 until participant met study treatment discontinuation criteria. Participants also received up to 8 treatments of CAPOX. Oxaliplatin was administered 130 mg/m^2 IV on day 1 of each cycle over 2 hours for a maximum of 8 treatments; Capecitabine was administered orally at 1000 mg/m^2 bid on days 1 through 14 of each cycle until the participant met study treatment discontinuation criteria. After a maximum of 8 treatments of oxaliplatin, participants may have continued to receive capecitabine taken twice daily on days 1 through 14 of each cycle at the investigator's discretion until the participant met study treatment discontinuation criteria. Each cycle was approximately 21 days. |
|
|
|
| OG001 | CAPOX+ Placebo | Participants received an IV infusion (as a minimum of 2-hour infusion) of placebo matched to zolbetuximab on C1D1 followed by subsequent doses every 3 weeks starting from C2D1 until participant met study treatment discontinuation criteria. Participants also received up to 8 treatments of CAPOX. Oxaliplatin was administered 130 mg/m^2 IV on day 1 of each cycle over 2 hours for a maximum of 8 treatments; Capecitabine was administered orally at 1000 mg/m^2 bid on days 1 through 14 of each cycle until the participant met study treatment discontinuation criteria. After a maximum of 8 treatments of oxaliplatin, participants may have continued to receive capecitabine taken twice daily on days 1 through 14 of each cycle at the investigator's discretion until the participant met study treatment discontinuation criteria. Each cycle was approximately 21 days. |
|
|
| OG001 | CAPOX+ Placebo | Participants received an IV infusion (as a minimum of 2-hour infusion) of placebo matched to zolbetuximab on C1D1 followed by subsequent doses every 3 weeks starting from C2D1 until participant met study treatment discontinuation criteria. Participants also received up to 8 treatments of CAPOX. Oxaliplatin was administered 130 mg/m^2 IV on day 1 of each cycle over 2 hours for a maximum of 8 treatments; Capecitabine was administered orally at 1000 mg/m^2 bid on days 1 through 14 of each cycle until the participant met study treatment discontinuation criteria. After a maximum of 8 treatments of oxaliplatin, participants may have continued to receive capecitabine taken twice daily on days 1 through 14 of each cycle at the investigator's discretion until the participant met study treatment discontinuation criteria. Each cycle was approximately 21 days. |
|
|
| OG001 | CAPOX+ Placebo | Participants received an IV infusion (as a minimum of 2-hour infusion) of placebo matched to zolbetuximab on C1D1 followed by subsequent doses every 3 weeks starting from C2D1 until participant met study treatment discontinuation criteria. Participants also received up to 8 treatments of CAPOX. Oxaliplatin was administered 130 mg/m^2 IV on day 1 of each cycle over 2 hours for a maximum of 8 treatments; Capecitabine was administered orally at 1000 mg/m^2 bid on days 1 through 14 of each cycle until the participant met study treatment discontinuation criteria. After a maximum of 8 treatments of oxaliplatin, participants may have continued to receive capecitabine taken twice daily on days 1 through 14 of each cycle at the investigator's discretion until the participant met study treatment discontinuation criteria. Each cycle was approximately 21 days. |
|
|
| OG001 | CAPOX+ Placebo | Participants received an IV infusion (as a minimum of 2-hour infusion) of placebo matched to zolbetuximab on C1D1 followed by subsequent doses every 3 weeks starting from C2D1 until participant met study treatment discontinuation criteria. Participants also received up to 8 treatments of CAPOX. Oxaliplatin was administered 130 mg/m^2 IV on day 1 of each cycle over 2 hours for a maximum of 8 treatments; Capecitabine was administered orally at 1000 mg/m^2 bid on days 1 through 14 of each cycle until the participant met study treatment discontinuation criteria. After a maximum of 8 treatments of oxaliplatin, participants may have continued to receive capecitabine taken twice daily on days 1 through 14 of each cycle at the investigator's discretion until the participant met study treatment discontinuation criteria. Each cycle was approximately 21 days. |
|
|
| CAPOX+ Placebo |
Participants received an IV infusion (as a minimum of 2-hour infusion) of placebo matched to zolbetuximab on C1D1 followed by subsequent doses every 3 weeks starting from C2D1 until participant met study treatment discontinuation criteria. Participants also received up to 8 treatments of CAPOX. Oxaliplatin was administered 130 mg/m^2 IV on day 1 of each cycle over 2 hours for a maximum of 8 treatments; Capecitabine was administered orally at 1000 mg/m^2 bid on days 1 through 14 of each cycle until the participant met study treatment discontinuation criteria. After a maximum of 8 treatments of oxaliplatin, participants may have continued to receive capecitabine taken twice daily on days 1 through 14 of each cycle at the investigator's discretion until the participant met study treatment discontinuation criteria. Each cycle was approximately 21 days. |
|
|
| OG001 | CAPOX+ Placebo | Participants received an IV infusion (as a minimum of 2-hour infusion) of placebo matched to zolbetuximab on C1D1 followed by subsequent doses every 3 weeks starting from C2D1 until participant met study treatment discontinuation criteria. Participants also received up to 8 treatments of CAPOX. Oxaliplatin was administered 130 mg/m^2 IV on day 1 of each cycle over 2 hours for a maximum of 8 treatments; Capecitabine was administered orally at 1000 mg/m^2 bid on days 1 through 14 of each cycle until the participant met study treatment discontinuation criteria. After a maximum of 8 treatments of oxaliplatin, participants may have continued to receive capecitabine taken twice daily on days 1 through 14 of each cycle at the investigator's discretion until the participant met study treatment discontinuation criteria. Each cycle was approximately 21 days. |
|
|
| Units | Counts |
|---|
| Participants |
|
|
| Participants |
|
|