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| ID | Type | Description | Link |
|---|---|---|---|
| RCC-RAD-01 | Other Identifier | Novartis |
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| Name | Class |
|---|---|
| Novartis | INDUSTRY |
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Patients with metastatic renal cell cancer will be enrolled to receive RAD001 to determine whether the use of RAD001 will result in an improvement in the time to tumor progression.
Patients with metastatic renal cell cancer will be enrolled in the study if all eligibility criteria are met and they agree to participate. The participant will take RAD001 (Everolimus) 10mg by mouth once a day. During the first cycle, they will have blood work done once a week (4 weeks). On cycles thereafter they will have blood work on days 7 and 21. Once a month, the patient will have a chest x-ray. Every 8 weeks the patient will have a CT scan of the chest, abdomen and pelvis. If clinically indicated, additional tests will be done.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RAD001 | Experimental | Subjects will take RAD001 (Everolimus) 10mg by mouth daily. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RAD001 | Drug | Participant will take RAD001 (Everolimus) 10mg by mouth once a day. |
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| Measure | Description | Time Frame |
|---|---|---|
| To collect data on time to tumor progression produced by the study treatment. | restaging every 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Response rate | restaging every 8 weeks | |
| Duration of tumor response | restaging every 8 weeks | |
| Safety and toxicity |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robert J Amato, DO | Baylor College of Medicine - Methodist Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Baylor College of Medicine - Methodist Hospital | Houston | Texas | 77030 | United States |
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| ID | Term |
|---|---|
| D002292 | Carcinoma, Renal Cell |
| D007680 | Kidney Neoplasms |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| D000068338 | Everolimus |
| ID | Term |
|---|---|
| D020123 | Sirolimus |
| D018942 | Macrolides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
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| AEs as occur |
| Six month and 12 month survival rate | at 6 months and at 12 months |
| Overall survival | restaging every 8 weeks |
| D009369 | 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 |