A Study of Gentuximab + Paclitaxel in Patients With Advanced Gastric or Gastroesophageal Junction Cancer
NCT ID: NCT04053205
Last Updated: 2019-08-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1/PHASE2
76 participants
INTERVENTIONAL
2019-08-31
2020-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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1 Gentuximab+ Paclitaxel
8 mg/kg Gentuximab administered intravenously (IV) on D1 and D15（28 days every cycle）+ 80 mg/m² paclitaxel administered IV on D1, D8 and D15
Gentuximab
Administered intravenously (IV)
Paclitaxel
Administered intravenously (IV)
2 Gentuximab+ Paclitaxel
12 mg/kg Gentuximab administered intravenously (IV) on D1 and D15（28 days every cycle）+ 80 mg/m² paclitaxel administered IV on D1, D8 and D15
Gentuximab
Administered intravenously (IV)
Paclitaxel
Administered intravenously (IV)
Interventions
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Gentuximab
Administered intravenously (IV)
Paclitaxel
Administered intravenously (IV)
Eligibility Criteria
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Inclusion Criteria
* Male or female. aged between 18 and 75 years
* Histopathologically confirmed advanced advanced gastric or gastroesophageal junction cancer, and Documented progression during first-line fluoropyrimidine- and platinum- containing chemotherapy, or during the 3 months following the last cycle of such chemotherapy (or during the 6 months following the last dose of adjuvant therapy or new adjuvant therapy containing fluoropyrimidine and platinium).
* At least one Measurable lesion.
* ECOG Performance status (PS) score, 0-1 level.
* A life expectancy of \>3 months.
* Adequate hematologic function, as defined by: Absolute neutrophil count (ANC) ≥1.5×109/L; hemoglobin concentration ≥90g/L (allowing blood transfusion); and platelet count ≥80×109/L.
* Adequate hepatic function, as defined by: ALT ≤ 2.5 × ULN, AST ≤ 2.5 × ULN, TBIL ≤ 1.5 × ULN (liver metastases patients ALT ≤ 5 × ULN, AST ≤ 5 × ULN, TBIL ≤ 3 × ULN).
* Adequate renal function, as defined by: serum creatinine level≤ 1.5 × ULN, or creatinine clearance ≥ 50ml / min when serum creatinine level\> 1.5 × ULN.
* Adequate coagulation function, as defined by: International normalized ratio (INR) ≤1.5× ULN, activated partial thromboplastin time (aPTT) ≤1.5 x ULN.
* 24-hour urine protein quantitation is \<1g（24-hour urine protein quantitative test should be performed when urine protein ≥1+ is found during screening visit）.
* Subjects (male and female) who have fertility must agree to use reliable contraceptive methods during the trial and in 3 months after the last administration. Female subjects in childbearing age must be negative for blood pregnancy test prior to enrollment.
Exclusion Criteria
* Systematic anti-tumor therapy (non-anti-angiogenic drugs or paclitaxel) such as chemotherapy, radiotherapy, macromolecular targeted therapy, immunotherapy, endocrine therapy, etc. within 4 weeks before the first dose of investigational drug, except for the following: nitrourea or mitomycin C is within 6 weeks before the first dose, oral fluorouracil and small molecule targeted drugs are within 2 weeks or 5 half-life of the drug(whichever is longer) before the first dose，Chinese medicine with anti-cancer indications is within 2 weeks before the first dose.
* Has participated in a clinical study of a non-approved experimental agent within 4 weeks prior to screening visit.
* Has undergone major surgery within 4 weeks before screening visit (not including needle biopsy)， or would undergo planned surgery during the study.
* Subject with positive HCV-Ab, Anti-HIV or TP-Ab, or positive HBS-Ag with copies of HBV DNA \> ULN.
* Patients with previously confirmed malignant tumors.
* History of arterial thrombosis or deep vein thrombosis within 6 months prior to screening, or a bleeding event no less than Grade level 3 within 2 months prior to screening， or the investigator determines that there is a risk of bleeding.
* History of severe cardiovascular and cerebrovascular diseases.
* Subjects with confirmed brain tumor metastases，but subjects in steady situation can be enrolled.
* Active bleeding confirmed by gastroscopy when fecal occult blood positive (only subjects with primary lesions not removed need to do fecal occult blood test.
* History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 12 months before screening visit.
* Thoracic，abdominal or pericardial effusion that cannot be controlled by repeated drainage or with obvious symptoms.
* Has a nonhealing wound, serious ulcer, or unrecovered bone fracture.
* Active infections requiring systemic treatment, including but not limited to active tuberculosis.
* Using anticoagulation and antiplatelet drugs.
* Female subjects who is pregnant (confirmed by urine or serum pregnancy test) or lactating.
* Has a known serious allergy reaction to recombination monoclonal antibody (MAb) drug, ,or infusion reaction.
* Has known alcohol or drug dependency.
18 Years
75 Years
ALL
No
Sponsors
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Shanghai East Hospital
OTHER
Zhejiang University
OTHER
Fujian Tumor Hospital
UNKNOWN
Sir Run Run Shaw Hospital
OTHER
The Affiliated Tumor Hospital of Harbin Medical University
UNKNOWN
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
OTHER
Sixth Affiliated Hospital, Sun Yat-sen University
OTHER
Tongji Hospital
OTHER
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
OTHER
The First Hospital of Jilin University
OTHER
The First Affiliated Hospital with Nanjing Medical University
OTHER
The First Affiliated Hospital of Zhengzhou University
OTHER
Changchun GeneScience Pharmaceutical Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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Fujian Tumor Hospital
Fuzhou, Fujian, China
The Sixth Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China
The Affiliated Tumor Hospital of Harbin Medical University
Harbin, Heilongjiang, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
Union Hospital of Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China
Jiangsu Province Hospital
Nanjing, Jiangsu, China
The First Hospital of Jilin University
Changchun, Jilin, China
Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology
Hangzhou, Zhejiang, China
Shanghai East Hospital
Shanghai, , China
Shanghai First People's Hospital
Shanghai, , China
Countries
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Central Contacts
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Facility Contacts
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Jianwei Yang
Role: primary
Yanhong Deng
Role: primary
Yuxian Bai
Role: primary
Qingxia Fan
Role: primary
Tao Zhang
Role: primary
Yanhong Gu
Role: primary
Wei Li
Role: primary
Hongming Pan
Role: primary
Nong Xu
Role: primary
Xianglin Yuan
Role: primary
Jin Li
Role: primary
Weiyi Huang
Role: primary
Other Identifiers
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GenSci 043 CT
Identifier Type: -
Identifier Source: org_study_id
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