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| ID | Type | Description | Link |
|---|---|---|---|
| NX1212CN | Other Identifier | company internal |
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This prospective, single arm, multi-center pilot study includes 120 mRCC patients over 65 years, no prior systemic treatment, determined to be candidates for systemic therapy by the investigator. The treatment with Sorafenib should comply with the recommendations written in the local product information. The primary endpoint is overall survival. The secondary endpoints including other effectiveness points, safety and patients characteristics. With 120 completed patients, if the observed survival rate at 12 months is 60%, the width of a 95% confidence interval will be approximately 18%.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sorafenib (Nexavar, BAY43-9006) | Drug | treatment (including dose, duration, modification) decided by the investigator |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | up to 2.5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Progression free survival by the Response Evaluation Criteria in Solid Tumor (RECIST) Criteria | up to 2.5 years | |
| Disease control rate by the Response Evaluation Criteria in Solid Tumor (RECIST) Criteria | up to 2.5 years |
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Inclusion Criteria:
Exclusion Criteria:
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mRCC patients, >= 65 years of age, No prior systemic treatment, need systemic therapy
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| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Many Locations | China |
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| ID | Term |
|---|---|
| D002292 | Carcinoma, Renal Cell |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| D000077157 | Sorafenib |
| ID | Term |
|---|---|
| D010671 | Phenylurea Compounds |
| D014508 | Urea |
| D000577 | Amides |
| D009930 | Organic Chemicals |
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| Survival rate by one year | up to 1 year |
| Number of participants with adverse events (AE) and Serious adverse events (SAE) as a measure of safety and tolerability | up to 3.5 years |
| Patient characteristics (birthdate (at least year), sex, weight, height, etc) | up to 2.5 years |
| Response rate (RR) | up to 3.5 years |
| Time to first relief of clinical symptoms and physical signs | up to 3.5 years |
| Treatment pattern | up to 3.5 years |
| D009369 | Neoplasms |
| D007680 | Kidney Neoplasms |
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
| D001555 |
| Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009536 | Niacinamide |
| D009539 | Nicotinic Acids |
| D000147 | Acids, Heterocyclic |
| D006571 | Heterocyclic Compounds |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |