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| Name | Class |
|---|---|
| Shanghai East Hospital | OTHER |
| Zhejiang University | OTHER |
| Fujian Cancer Hospital | OTHER_GOV |
| Sir Run Run Shaw Hospital |
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The objective of the study is to evaluate Tolerability, Safety, and primary Efficacy of Gentuximab Injection at different dosage in combination with Paclitaxel in Advanced Gastric or Gastroesophageal Junction Cancer patients, to ensure adequate treatment dosage for further study. Meanwhile, the study also evaluate Pharmacokinetics of Gentuximab Injection at different dosage in combination with Paclitaxel.
The study includes dose-limiting toxicity (DLT)observing period and randomization period with two cohorts as low-dose group(Gentuximab Injection 8mg/kg+ paclitaxel) and high-dose group(Gentuximab Injection 12mg/kg+ paclitaxel). During the study,the anti-cancer efficacy, safety and anti-drug antibody were evaluated in all patients. DLT observation is only to subjects enrolled in DLT observation period and it lasts one treatment period. PK were doing in part of subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 Gentuximab+ Paclitaxel | Experimental | 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 |
|
| 2 Gentuximab+ Paclitaxel | Experimental | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gentuximab | Drug | Administered intravenously (IV) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Dose-limiting toxicities (DLT) | Number of Participants With One or More Drug-Related Adverse Events (AEs) defined as DLT in the protocol | Up to 4 Weeks |
| AEs or SAEs | Drug-Related Adverse Events (AEs) or Any Serious Adverse Events (SAEs) | Baseline through Study Completion, about 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate(ORR) | Proportion of Participants With CR and PR | Up to 6 cycles (28 days for every cycle) |
| Progression-free survival (PFS) | The time from randomization to the patient tumor progression or death. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fujian Tumor Hospital | Fuzhou | Fujian | China | |||
| The Sixth Hospital of Sun Yat-sen University |
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| OTHER |
| The Second Affiliated Hospital of Harbin Medical University | OTHER |
| 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 |
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| Paclitaxel | Drug | Administered intravenously (IV) |
|
| Up to 6 cycles (28 days for every cycle) |
| Disease control rate (DCR) | Proportion of Participants With CR, PR and SD | Up to 6 cycles (28 days for every cycle) |
| Time-to-progress (TTP) | The time from randomization to the patient tumor progression. | Up to 6 cycles (28 days for every cycle) |
| Time-to-failure (TTF) | The time from randomization to the patient withdraw from the study. | Up to 6 cycles (28 days for every cycle) |
| Anti-drug antibody | Number of Participants With Anti-drug Antibodies | Up to 6 cycles (28 days for every cycle) |
| Pharmacokinetics Cmax | Maximum Concentration (Cmax) | Cycle 1(day1-day 15)& Cycle 2(day 15-day26) & Cycle 3(day 1) (28 days for every cycle) |
| Area Under the Concentration-Time Curve (AUC) | Cycle 1(day1-day 15)& Cycle 2(day 15-day26) & Cycle 3(day 1) Cycle 1(day1-day 15)& Cycle 2(day 15-day26) & Cycle 3(day 1) (28 days for every cycle) |
| 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 |
| ID | Term |
|---|---|
| D017239 | Paclitaxel |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
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