Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| NX1307RU | Other Identifier | company internal |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This local, prospective, multicenter, non-interventional study documents observational data on patients under routine treatment of metastatic RCC with Nexavar before and after cytoreductive nephrectomy. It's planned to better understand the impact of cytoreductive nephrectomy on Nexavar efficacy and possibly to define patients who get the most benefit from Nexavar before cytoreductive nephrectomy.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sorafenib (Nexavar, BAY 43-9006) | Drug | The patients under routine treatment of metastatic RCC with Nexavar before and after cytoreductive nephrectomy meeting the criteria of inclusion. |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum percent reduction (based on the minimum post baseline value) in the longest diameter of the primary tumor in response to neoadjuvant Nexavar treatment. | up to 2 years | |
| Response rate of residual disease to Nexavar according to RECIST 1.1 with baseline after cytoreductive nephrectomy. | up to 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Response before cytoreductive nephrectomy according to RECIST 1.1. | up to 2 years | |
| Maximum percent reduction in the sum of longest diameters of target lesions according to RECIST 1.1 while on Nexavar treatment before cytoreductive nephrectomy | up to 2 years |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Diagnosis of any second malignancy within the last 5 years, except for adequately treated basal cell carcinoma, squamous cell skin cancer, or in situ cervical cancer.
All contra-indications according to the Russian marketing authorization:
Not provided
Not provided
Not provided
Male and female patients ≥ 18 years old with untreated metastatic RCC for whom treatment with Nexavar is planned with subsequent cytoreductive nephrectomy and resumption of Nexavar in case of clinical feasibility
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Multiple Locations | Russia |
Not provided
| ID | Term |
|---|---|
| D002292 | Carcinoma, Renal Cell |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077157 | Sorafenib |
| ID | Term |
|---|---|
| D010671 | Phenylurea Compounds |
| D014508 | Urea |
| D000577 | Amides |
| D009930 | Organic Chemicals |
Not provided
Not provided
Not provided
Not provided
Not provided
| Maximum percent reduction in the sum of longest diameters of target lesions of residual disease after cytoreductive nephrectomy according to RECIST 1.1 while on Nexavar treatment with baseline after cytoreductive nephrectomy. | up to 2 years |
| Number of participants with AEs, including intra- and postoperative complications, relation to Nexavar treatment, AEs treatment, AEs outcome. | up to 2 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 |