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| ID | Type | Description | Link |
|---|---|---|---|
| D0750018 |
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This study drug(Amrubicin)is believed to work by stopping the tumor cell in your body from growing. The purpose of this study is to evaluate the efficacy and safety of amrubicin with cisplatin compared to etoposide-cisplatin in the first-line treatment in extensive disease small cell lung cancer The subject, who is randomized to AP group may be involved into a pharmacokinetic study of amrubicin and the metabolites: amrubicinol voluntarily.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Amrubicin Hydrochloride-Cisplatin combined chemotherapy |
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| 2 | Active Comparator | Etoposide-Cisplatin combined chemotherapy |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Amrubicin Hydrochloride | Drug | Amrubicin Hydrochloride combined with cisplatin |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival | 1.5 years after last subject enrolled |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-Free Survival | 1.5 years after last subject enrolled | |
| Objective Response Rate | Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival at 6 and 12 Months | 6 and 12 months. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yan Sun, MD | Cancer Hospital Chinese Academy of Medical Science | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fuzhou | Fujian | China | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27061082 | Derived | Sun Y, Cheng Y, Hao X, Wang J, Hu C, Han B, Liu X, Zhang L, Wan H, Xia Z, Liu Y, Li W, Hou M, Zhang H, Xiu Q, Zhu Y, Feng J, Qin S, Luo X. Randomized phase III trial of amrubicin/cisplatin versus etoposide/cisplatin as first-line treatment for extensive small-cell lung cancer. BMC Cancer. 2016 Apr 9;16:265. doi: 10.1186/s12885-016-2301-6. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Amrubicin Combined With Cisplatin Group | Amrubicin Hydrochloride-Cisplatin combined chemotherapy Amrubicin Hydrochloride : Amrubicin Hydrochloride combined with cisplatin |
| FG001 | Etoposide Combined With Cisplatin Group |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Etoposide-Cisplatin combined chemotherapy |
| Drug |
combined chemotherapy |
|
| participants were followed for the duration of the study, an average of 12 weeks |
| Lanzhou |
| Gansu |
| China |
| Guangzhou | Guangdong | China |
| Changsha | Hunan | China |
| Nanjing | Jiangsu | China |
| Nanchang | Jiangxi | China |
| Changchun | Jilin | China |
| Dalian/Shenyang | Liaoning | China |
| Shenyang | Liaoning | China |
| Xian | Shanxi | China |
| Chengdu | Sichuan | China |
| Hangzhou | Zhejiang | China |
| Beijing | China |
| Shanghai | China |
| Tianjin | China |
Etoposide-Cisplatin combined chemotherapy
Etoposide-Cisplatin combined chemotherapy : combined chemotherapy
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Amrubicin, Anticancer, Injection | |
| BG001 | Etoposide, Anticancer, Injection | |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| 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 | Overall Survival | Posted | Median | 95% Confidence Interval | month | 1.5 years after last subject enrolled |
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| Other Pre-specified | Overall Survival at 6 and 12 Months | Posted | Number | 95% Confidence Interval | percentage of patients | 6 and 12 months. |
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| Secondary | Progression-Free Survival | Posted | Median | 95% Confidence Interval | month | 1.5 years after last subject enrolled |
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| Secondary | Objective Response Rate | Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. | Posted | Number | percentage of participants | participants were followed for the duration of the study, an average of 12 weeks |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Amrubicin, Anticancer, Injection | 21 | 149 | 149 | 149 | |||
| EG001 | Etoposide, Anticancer, Injection | 8 | 150 | 148 | 150 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | MedDRA 14.0 | Systematic Assessment |
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| Agranulocytosis | Blood and lymphatic system disorders | MedDRA 14.0 | Systematic Assessment |
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| Febrile neutropenia syndrome | Blood and lymphatic system disorders | MedDRA 14.0 | Systematic Assessment |
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| Bone marrow failure | Blood and lymphatic system disorders | MedDRA 14.0 | Systematic Assessment |
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| Supraventricular tachycardia | Cardiac disorders | MedDRA 14.0 | Systematic Assessment |
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| Ventricular arrhythmias | Cardiac disorders | MedDRA 14.0 | Systematic Assessment |
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| Diarrhea | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
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| Gastrointestinal Disorders | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
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| fever | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
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| Chronic cholecystitis | Vascular disorders | MedDRA 14.0 | Systematic Assessment |
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| Bronchitis | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
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| Lower hemoglobin | Investigations | MedDRA 14.0 | Systematic Assessment |
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| Neutrophil count decreased | Investigations | MedDRA 14.0 | Systematic Assessment |
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| Platelet count decreased | Investigations | MedDRA 14.0 | Systematic Assessment |
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| White blood cell count decreased | Investigations | MedDRA 14.0 | Systematic Assessment |
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| Hypokalemia | Metabolism and nutrition disorders | MedDRA 14.0 | Systematic Assessment |
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| Cerebral infarction | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
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| Dyskinesia | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
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| Speech disorder | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
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| Spinal cord compression | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
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| Acute renal failure | Renal and urinary disorders | MedDRA 14.0 | Systematic Assessment |
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| Mental disorders | Psychiatric disorders | MedDRA 14.0 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
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| vomit | Gastrointestinal disorders | MedDRA 14.0 | Non-systematic Assessment |
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| Decreased appetite | Gastrointestinal disorders | MedDRA 14.0 | Non-systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA 14.0 | Non-systematic Assessment |
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| Alopecia | General disorders | MedDRA 14.0 | Non-systematic Assessment |
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| fever | Infections and infestations | MedDRA 14.0 | Non-systematic Assessment |
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| Fatigue | General disorders | MedDRA 14.0 | Non-systematic Assessment |
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| Diarrhea | Gastrointestinal disorders | MedDRA 14.0 | Non-systematic Assessment |
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| Gastrointestinal Disorders | Gastrointestinal disorders | MedDRA 14.0 | Non-systematic Assessment |
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| Neutrophil count decreased | Blood and lymphatic system disorders | MedDRA 14.0 | Non-systematic Assessment |
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| White blood cell count decreased | Blood and lymphatic system disorders | MedDRA 14.0 | Non-systematic Assessment |
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| Platelet count decreased | Blood and lymphatic system disorders | MedDRA 14.0 | Non-systematic Assessment |
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| Lower hemoglobin | Blood and lymphatic system disorders | MedDRA 14.0 | Non-systematic Assessment |
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| Anemia | Blood and lymphatic system disorders | MedDRA 14.0 | Non-systematic Assessment |
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| Bone marrow failure | Blood and lymphatic system disorders | MedDRA 14.0 | Non-systematic Assessment |
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| Decreased red blood cell count | Blood and lymphatic system disorders | MedDRA 14.0 | Non-systematic Assessment |
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| Mouth ulcers | Gastrointestinal disorders | MedDRA 14.0 | Non-systematic Assessment |
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| Abnormal liver function | Hepatobiliary disorders | MedDRA 14.0 | Non-systematic Assessment |
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| Lymphocyte count decreased | Investigations | MedDRA 14.0 | Non-systematic Assessment |
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| Reduced red blood cell count | Investigations | MedDRA 14.0 | Non-systematic Assessment |
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| Hypocalcemia | Metabolism and nutrition disorders | MedDRA 14.0 | Non-systematic Assessment |
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| Hypochloraemia | Metabolism and nutrition disorders | MedDRA 14.0 | Non-systematic Assessment |
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| Hypokalemia | Metabolism and nutrition disorders | MedDRA 14.0 | Non-systematic Assessment |
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| Hyponatremia | Metabolism and nutrition disorders | MedDRA 14.0 | Non-systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 14.0 | Non-systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 14.0 | Non-systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA 14.0 | Non-systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Non-systematic Assessment |
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| Hemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Non-systematic Assessment |
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| Hiccup | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Non-systematic Assessment |
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| alanine aminotransferase increased | General disorders | MedDRA 14.0 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr.Sunyan | Cancer Hospital of Chinese Academy of Medical Sciences | 86-10-87788519 | suny@csco.org.cn |
| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| C055866 | amrubicin |
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| Male |
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