[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100275228":3},{"organization":4,"armGroups":7,"interventions":30,"overallOfficials":55,"centralContacts":42,"locations":59,"responsibleParty":84,"collaborators":42,"id":86,"slug":87,"hasResults":88,"nctId":89,"briefTitle":90,"officialTitle":91,"acronym":42,"eligibilityCriteria":92,"healthyVolunteers":93,"sex":94,"minAge":95,"maxAge":42,"enrollmentInfo":96,"targetDuration":42,"studyType":99,"phases":100,"briefSummary":102,"conditions":103,"keywords":42,"overallStatus":105,"whyStopped":106,"lastUpdateSubmitDate":107,"lastUpdatePostDateStruct":108,"startDateStruct":110,"completionDateStruct":112,"leadSponsor":114,"locationsCount":115},{"fullName":5,"class":6},"Gilead Sciences","INDUSTRY",[8,14,20,25],{"label":9,"type":10,"description":11,"interventionNames":12},"Cohort 1: ADX","EXPERIMENTAL","Participants will receive andecaliximab (ADX) 800 mg every 2 weeks on Days 1 and 15 of each 28-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.",[13],"Drug: Andecaliximab",{"label":15,"type":10,"description":16,"interventionNames":17},"Cohort 2: ADX + S-1 + Cisplatin","Participants will receive ADX 800 mg every 2 weeks on Days 1 and 15 of each 28-day treatment cycle in combination with S-1 orally twice daily plus cisplatin chemotherapy (dosage and regimen will be based on participant condition, investigator discretion, institutional practice, and\u002For the in-country label) until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.",[13,18,19],"Drug: S-1","Drug: Cisplatin",{"label":21,"type":10,"description":22,"interventionNames":23},"Cohort 3: ADX + S-1 + Oxaliplatin","Participants will receive ADX 1200 mg every 3 weeks on Day 1 of each 21-day treatment cycle in combination with chemotherapy (S-1 80 mg\u002Fday to 120 mg\u002Fday according to the body surface area orally twice daily for first 14 days of 21 day cycle plus oxaliplatin 100 mg\u002Fm\\^2) until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study.",[13,18,24],"Drug: Oxaliplatin",{"label":26,"type":10,"description":27,"interventionNames":28},"Cohort 4: ADX + Nivolumab","Participants will receive ADX 800 mg every 2 weeks followed by chemotherapy (nivolumab 3 mg\u002Fkg) on Days 1 and 15 of each 28-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.",[13,29],"Drug: Nivolumab",[31,38,43,47,51],{"type":32,"name":33,"description":34,"armGroupLabels":35,"otherNames":36},"DRUG","Andecaliximab","Administered via intravenous (IV) infusion (approximately 30 minutes)",[9,15,21,26],[37],"GS-5745",{"type":32,"name":39,"description":40,"armGroupLabels":41,"otherNames":42},"S-1","Administered orally",[15,21],null,{"type":32,"name":44,"description":45,"armGroupLabels":46,"otherNames":42},"Cisplatin","Administered via IV infusion on Day 8 of every 5 weeks",[15],{"type":32,"name":48,"description":49,"armGroupLabels":50,"otherNames":42},"Oxaliplatin","Administered via IV infusion for over 2 hours on Day 1 of each 21-day cycle",[21],{"type":32,"name":52,"description":53,"armGroupLabels":54,"otherNames":42},"Nivolumab","Administered via IV infusion (approximately 60 minutes) every 2 weeks",[26],[56],{"name":57,"affiliation":5,"role":58},"Gilead Study Director","STUDY_DIRECTOR",[60,70,77],{"facility":42,"status":42,"city":61,"state":42,"zip":42,"country":62,"countryCode":63,"cosmosGeoPoint":64,"geoPoint":69,"contacts":42},"Nagoya","Japan","JP",{"type":65,"coordinates":66},"Point",[67,68],136.90641,35.18147,{"lat":68,"lon":67},{"facility":42,"status":42,"city":71,"state":42,"zip":42,"country":62,"countryCode":63,"cosmosGeoPoint":72,"geoPoint":76,"contacts":42},"Osaka",{"type":65,"coordinates":73},[74,75],135.50107,34.69379,{"lat":75,"lon":74},{"facility":42,"status":42,"city":78,"state":42,"zip":42,"country":62,"countryCode":63,"cosmosGeoPoint":79,"geoPoint":83,"contacts":42},"Tokyo",{"type":65,"coordinates":80},[81,82],139.69171,35.6895,{"lat":82,"lon":81},{"type":85,"investigatorFullName":42,"investigatorTitle":42,"investigatorAffiliation":42,"oldNameTitle":42,"oldOrganization":42},"SPONSOR","100275228","phase-1-study-to-evaluate-the-safety-and-tolerability-of-andecaliximab-as-monotherapy-and-in-combination-with-anti-cancer-agents-in-japanese-participants-with-gastric-or-gastroesophageal-junction-adenocarcinoma-100275228",true,"NCT02862535","Study to Evaluate the Safety and Tolerability of Andecaliximab as Monotherapy and in Combination With Anti-Cancer Agents in Japanese Participants With Gastric or Gastroesophageal Junction Adenocarcinoma","A Phase 1b Study to Evaluate the Safety and Tolerability of Andecaliximab (GS-5745) as Monotherapy and in Combination With Anti-Cancer Agents in Japanese Subjects With Gastric or Gastroesophageal Junction Adenocarcinoma","Key Inclusion Criteria:\n\n* Must have been born in Japan and must not have lived outside of Japan for a period \\> 1 year in the 5 years prior to Day 1\n* Must be able to trace their maternal and paternal ancestry of parents and grandparents as ethnically Japanese\n* Histologically confirmed inoperable advanced gastric adenocarcinoma (including adenocarcinoma of the GEJ) or relapsed gastric adenocarcinoma\n* Cohorts 1, 2, and 3: Human Epidermal Growth Factor Receptor 2 (HER2)-negative tumor (primary tumor or metastatic lesion). Enrollment in Cohort 4 is not restricted by HER2 status (adults with HER2-positive, HER2-negative, or unknown HER2 status are eligible)\n* Cohort 1: Prior antitumor therapy or cytotoxic chemotherapy is acceptable. Individuals who are not eligible to receive standard treatments should enroll on the study.\n* Cohorts 2 and 3: Prior antitumor therapy or cytotoxic chemotherapy for metastatic disease is not acceptable. Individuals must be chemo-naive in the metastatic setting\n* Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 1\n* Adequate baseline organ function (within 28 days prior to Day 1)\n* Coagulation: International Normalized Ratio (INR) ≤ 1.5 (unless receiving anticoagulation therapy)\n* For females of childbearing potential, willingness to use a protocol-recommended method of contraception from the screening visit throughout the study treatment period and for defined periods following the last dose of andecaliximab and\u002For anti-cancer agent(s)\n* For males of childbearing potential having intercourse with females of childbearing potential, willingness to use a protocol-recommended method of contraception from the start of andecaliximab, throughout the study treatment period, and for protocol defined periods following the last dose of andecaliximab and\u002For anti-cancer agent(s)\n* Willingness to comply with scheduled visits, drug administration plan, imaging studies, laboratory tests, other study procedures, and study restrictions\n* In addition to the applicable criteria above, participants in Cohort 4 must meet additional inclusion criteria to be eligible for participation in this study:\n\n  * Measurable gastric or GEJ adenocarcinoma\n  * Must have progressed on at least 1 prior systemic therapy or line of treatment for unresectable\u002Fmetastatic disease.\n  * Activated partial thromboplastin (aPTT) ≤ 1.5 times the upper limit of normal\n  * Thyroid function tests should be within normal limits.\n\nKey Exclusion Criteria:\n\n* History or evidence of a clinically significant disorder, condition, or disease that, in the opinion of the investigator and medical monitor would pose a risk to participant safety or interfere with the study evaluations, procedures, or completion\n* Pregnant or lactating. Enrollment of lactating females after discontinuation of breastfeeding is not acceptable.\n* Individuals with known central nervous system (CNS) metastases, unless metastases are treated and stable and the individual does not require systemic steroids\n* Radiotherapy within 28 days of Day 1\n* Myocardial infarction, symptomatic congestive heart failure (New York Heart Association Classification \\> Class II), unstable angina, or serious uncontrolled cardiac arrhythmia within the last 6 months of Day 1\n* History of major surgery within 28 days of Day 1\n* Serious systemic fungal, bacterial, viral, or other infection that is not controlled or requires IV antibiotics\n* Individuals known to be positive for human immunodeficiency virus (HIV), hepatitis C infection (per local standard diagnostic criteria), or acute or chronic hepatitis B infection (per local standard diagnostic criteria)\n* In addition to the applicable criteria above, participants in Cohort 4 who meet any of the following exclusion criteria will not be enrolled in this study\n\n  * Have received only neoadjuvant or adjuvant therapy for gastric adenocarcinoma\n  * Prior treatment with anti-cytotoxic T-lymphocyte-associated protein 4 (anti-CTLA-4) agents, anti-programmed cell death protein 1 (anti PD-1) or anti-programmed cell death ligand 1 (anti-PD-L1) agents, anti-programmed cell death ligand 2 (anti-PD-L2) agents, anti-matrix metalloprotease (anti-MMP) agents, or other immunomodulatory therapies\n\nNOTE: Other protocol defined Inclusion\u002F Exclusion criteria may apply.",false,"ALL","20 Years",{"count":97,"type":98},36,"ACTUAL","INTERVENTIONAL",[101],"PHASE1","The primary objective of this study is to characterize the safety and tolerability of andecaliximab as monotherapy and in combination with anti-cancer agents in Japanese participants with inoperable advanced or recurrent gastric or recurrent gastroesophageal junction (GEJ) adenocarcinoma.",[104],"Gastric Adenocarcinoma","TERMINATED","Study was terminated due to sponsor's decision to not pursue further development of andecaliximab in oncology","2020-11-30",{"date":109,"type":98},"2020-12-24",{"date":111,"type":98},"2016-09-20",{"date":113,"type":98},"2019-10-25",{"name":5,"class":6},3]