Gastric adenocarcinoma and Gastroesophageal Junction (GEJ) adenocarcinoma
Conditions
Interventions
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
Sponsors
Astellas Pharma Global Development, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Female subject eligible to participate if she is not pregnant and at least one of the following conditions applies: a. Not a woman of child-bearing potential (WOCBP) OR b. 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 2. 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. 3. 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. 4. 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. 5. 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. 6. 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. 7. Subject has histologically confirmed diagnosis of Gastric or GEJ adenocarcinoma. 8. Subject has radiologically confirmed locally advanced unresectable or metastatic disease within 28 days prior to randomization. 9. Subject has radiologically evaluable disease (measurable and/or non-measurable disease according to RECIST 1.1), per local assessment, = 75% of tumor cells demonstrating moderate to strong membranous staining as determined by central immunohistochemistry (IHC) testing. 11. Subject has a HER2-Negative tumor as determined by local or central testing on a gastric or GEJ tumor specimen. 12. Subject has Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1. 13. Subject has predicted life expectancy => 12 weeks. 14. 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. a. Hemoglobin (Hgb) => 9 g/dL. Subjects requiring transfusions are eligible if they have a post-transfusion Hgb => 9 g/dL. b. Absolute neutrophil count (ANC) => 1.5 x 10^9/L. c. Platelets => 100 x 10^9/L. d. Albumin => 2.5 g/dL. e. Total bilirubin = 30 mL/min h. Prothrombin time (PT)/international normalized ratio (INR) and partial thromboplastin
Exclusion criteria
Exclusion criteria: 1. 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. 2. Subject has received radiotherapy for locally advanced unresectable or metastatic gastric or GEJ adenocarcinoma = 450 msec for male subjects; QTc interval > 470 msec for female subjects d. History or family history of congenital long QT syndrome e. Cardiac arrhythmias requiring anti-arrhythmic medications (Subject with rate controlled atrial fibrillation for > 1 month prior to randomization are eligible). 15. Subject has a history of central nervous system (CNS) metastases and/or carcinomatous meningitis from gastric/GEJ cancer. 16. Subject has known peripheral sensory neuropathy > Grade 1. 17. 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. 18. Subject has psychiatric illness or social situations that would preclude study compliance. 19. Subject has another malignancy for which treatment is required. 20. Subject has any concurrent disease, infection or comorbid condition that interferes with the ability of the subject to participate in the study, which place
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - Progression-free survival (PFS) | — |
Secondary
| Measure | Time frame |
|---|---|
| - Overall survival (OS) - Objective Response Rate (ORR) - Duration Of Response (DOR) - Adverse events (AEs) - Laboratory assessments, vital signs, electrocardiograms (ECG) - Eastern Cooperative Oncology Group (ECOG) performance status - Health Related Quality of Life (HRQoL) - measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Core Questionnaire 30 (EORTC QLQ-C30), QLQ- Oesophago-Gastric Module 25 (OG25), Global Pain (GP), and EuroQOL Five Dimensions Questionnaire 5L (EQ5D-5L). - Time to confirmed deterioration (TTCD) - calculated based on physical functioning measured by EORTC QLQ-C30 and QLQ-25, OG25-Pain, and general health status/quality of life (GHS/QoL). - Pharmacokinetics of zolbetuximab, Ctrough - Immunogenicity of zolbetuximab as mensurated by the frequency of anti-drug antibody (ADA). | — |
Countries
Australia, Belgium, Brazil, Canada, Chile, China, Colombia, France, Germany, Israel, Italy, Japan, Mexico, Peru, Poland, South Korea, Spain, Taiwan, United Kingdom, United States of America
Outcome results
None listed