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| ID | Type | Description | Link |
|---|---|---|---|
| CRAD001C2480 |
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| Name | Class |
|---|---|
| Novartis | INDUSTRY |
| Bayer | INDUSTRY |
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This study is being done in 2 parts. The first part is to determine the dose of RAD001 that should be used in combination with sorafenib. The second part is using the above determined dose of RAD001 in combination with sorafenib to see how effective these 2 drugs are against advanced kidney cancer.
Participants will be asked to keep a pill diary.
The drugs used in this trial are called targeted drugs as they target specific activities that are carried out by cancer cells that make them grow and spread. Sorafenib is an approved drug for the treatment of advanced kidney cancer. RAD001 is an experimental drug that has been used in other research studies with other types of cancer. In this trial, the use of RAD001 and sorafenib together for the treatment of kidney cancer is experimental. In the Phase I portion of this study 13-16 patients will be treated with the same dose of sorafenib and different doses of RAD001. The purpose is to see what is a safe dose of RAD001 when combined with sorafenib in the treatment of kidney cancer. Once this dose of RAD001 is determined, about 65 more patients will be treated to see how effective this combination of drugs is against this kidney cancer.
Both of these drugs are taken by mouth. Sorafenib will be taken twice a day. RAD001 is taken by mouth weekly. Patients will be able to continue treatment as long as their disease does not worsen or side effects become intolerable.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RAD001 and Sorafenib | Experimental | RAD001 and Sorafenib |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sorafenib | Drug | Sorafenib |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall Response Rate (ORR) of Patients Treated at MTD/Phase II Dose Level | Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI or CT: 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 Rate (ORR) = Percentage of Patients Who Experience an Objective Response (CR+ PR) to Treatment. In oncology, this outcome measure is reported for all patients treated at the same dose level and is not separated into Phase I and Phase II. The phase I and phase II results are not separated out as the timing of their enrollment (early in phase 1 or later phase II) is not relevant to the outcome measure. | 18 months |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-Free Survival for Patients Treated at MTD/Phase II Dose Level | Progression is Defined Using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% Increase in the Sum of the Longest Diameter of Target Lesions, or a Measurable Increase in a Non-target Lesion, or the Appearance of New Lesions. Progression-free survival was defined as the interval from the date of study entry until the date of tumor progression or death for the patients treated at the MTD/Phase II dose level. This outcome measure is reported for all patients treated at the same dose level and is not separated into Phase I and Phase II. The phase I and phase II results are not separated out as the timing of their enrollment (early in phase 1 or later phase II) is not relevant to the outcome measure. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Please note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have. You can then decide if you wish to participate.
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| Name | Affiliation | Role |
|---|---|---|
| John D Hainsworth, MD | SCRI Development Innovations, LLC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Florida Hospital Cancer Institute | Orlando | Florida | 32804 | United States | ||
| Northeast Georgia Medical Center |
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| ID | Title | Description |
|---|---|---|
| FG000 | Phase 1 Dose Level 1 | sorafenib 400 mg BID and everolimus 35 mg once weekly |
| FG001 | Phase 1 Dose Level -1 | Sorafenib 200 mg PO BID, everolimus 35 mg PO once weekly |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
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| RAD001 | Drug | RAD001 |
|
|
| 18 months |
| Gainesville |
| Georgia |
| 30501 |
| United States |
| Wellstar Cancer Research | Marietta | Georgia | 30060 | United States |
| Baptist Hospital East | Louisville | Kentucky | 40207 | United States |
| Norton Cancer Institute | Louisville | Kentucky | 40207 | United States |
| Research Medical Center | Kansas City | Missouri | 64132 | United States |
| Hematology Oncology Associates of Northern NJ | Morristown | New Jersey | 07960 | United States |
| Oncology Hematology Care | Cincinnati | Ohio | 45242 | United States |
| South Carolina Oncology Associates, PA | Columbia | South Carolina | 29210 | United States |
| Spartanburg Regional Medical Center | Spartanburg | South Carolina | 29303 | United States |
| Tennessee Oncology, PLLC | Nashville | Tennessee | 37023 | United States |
| FG002 | Phase II | 200 mg PO BID and everolimus 35 mg PO once weekly |
| COMPLETED |
|
| NOT COMPLETED |
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Phase 1 Dose Level 1 | sorafenib 400 mg BID and everolimus 35 mg once weekly |
| BG001 | Phase 1 Dose Level -1 | Sorafenib 200 mg PO BID, everolimus 35 mg PO once weekly |
| BG002 | Phase II | 200 mg PO BID and everolimus 35 mg PO once weekly |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
|
| 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 Response Rate (ORR) of Patients Treated at MTD/Phase II Dose Level | Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI or CT: 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 Rate (ORR) = Percentage of Patients Who Experience an Objective Response (CR+ PR) to Treatment. In oncology, this outcome measure is reported for all patients treated at the same dose level and is not separated into Phase I and Phase II. The phase I and phase II results are not separated out as the timing of their enrollment (early in phase 1 or later phase II) is not relevant to the outcome measure. | Pts who received MTD dose also called Phase II dose (Sorafenib 200 mg PO BID, everolimus 35 mg). The 6 phase I pts and 69 phase II pts treated at this dose level are combined to evaluate the efficacy of the MTD/phase II dose. The Ph I and Ph II results are not separated out as the timing of their enrollment (early in Ph 1 or later Ph II) is not relevant to the outcome measure. 3 Ph I patients who were not treated at the MTD are excluded as this Outcome Measure is for MTD/Phase II dose level only | Posted | Number | 95% Confidence Interval | percentage of evaluable patients | 18 months |
|
|
| |||||||||||||||||||||||||
| Secondary | Progression-Free Survival for Patients Treated at MTD/Phase II Dose Level | Progression is Defined Using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% Increase in the Sum of the Longest Diameter of Target Lesions, or a Measurable Increase in a Non-target Lesion, or the Appearance of New Lesions. Progression-free survival was defined as the interval from the date of study entry until the date of tumor progression or death for the patients treated at the MTD/Phase II dose level. This outcome measure is reported for all patients treated at the same dose level and is not separated into Phase I and Phase II. The phase I and phase II results are not separated out as the timing of their enrollment (early in phase 1 or later phase II) is not relevant to the outcome measure. | Pts who received MTD dose also called Phase II dose (Sorafenib 200 mg PO BID, everolimus 35 mg). The 6 phase I pts and 69 phase II pts treated at this dose level are combined to evaluate the efficacy of the MTD/phase II dose. The Ph I and Ph II results are not separated out as the timing of their enrollment (early in Ph 1 or later Ph II) is not relevant to the outcome measure. 3 Ph I patients who were not treated at the MTD are excluded as this Outcome Measure is for MTD/Phase II dose level only | Posted | Median | 95% Confidence Interval | Months | 18 months |
|
Not provided
Not provided
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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 | Phase 1 Dose Level 1 | sorafenib 400 mg BID and everolimus 35 mg once weekly | 0 | 3 | 3 | 3 | ||
| EG001 | Phase 1 Dose Level -1 | Sorafenib 200 mg PO BID, everolimus 35 mg PO once weekly | 0 | 6 | 6 | 6 | ||
| EG002 | Phase II | 200 mg PO BID and everolimus 35 mg PO once weekly | 21 | 69 | 69 | 69 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ascites | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| CNS Ischemia | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Chronic Obstructive Pulmonary Disease | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Edema | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Fever | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hemorrhage, GI | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hernia | Injury, poisoning and procedural complications | CTCAE (3.0) | Systematic Assessment |
| |
| Infection - lung (pneumonia) | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Kidney stones | Renal and urinary disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE (3.0) | Systematic Assessment |
| |
| Nephrotic syndrome | Renal and urinary disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Pain - back | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Pain - chest | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Pain - stomach | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Proteinuria | Renal and urinary disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Sepsis | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Stabilization of thoracic spine | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Vascular - atherosclerosis | Vascular disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Ventricular tachycardia | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acne | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Albumin | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| Alkaline Phosphatase | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Anemia | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| AST, SGOT | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| Bilirubin - abnormal | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| Blisters | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Bronchiospasm | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| CNS ischemia | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Constitutional symptoms, Other (Temperature intolerance) | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Cough | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Creatinine increased | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Edema: limb | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Edema: NOS | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Edema:headandneck | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Elevated BUN | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Fatigue | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| fever | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hand-Foot Syndrome | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Headache | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hematologic: ANC | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| Hematologic: Hemoglobin | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| Hematologic: Platelets | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| Hematologic: WBC | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| Hematuria | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| Hemorrhage(nose) | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hypercalcemia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hyperchloridemia | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| Hypercholesterolemia | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| Hyperglycemia | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| Hyperkalemia | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| Hyperlipidemia | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| Hypermagnesemia | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| Hypernatremia | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| Hyperpigmentation | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hypertension | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hypertriglyceridemia | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| hyperuricemia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hypocalcemia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hypochloridemia | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| Hypokalemia | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| Hypomagnesemia | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| Hyponatremia | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| Hypophosphatemia | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| Increased Alanine transaminase, ALT, SGPT | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| Infection (Eye) | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Infection (joint) | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Infection(Sinus) | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Infection(Urinary) | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| insomnia | Psychiatric disorders | CTCAE (3.0) | Systematic Assessment |
| |
| International normalized ratio - abnormal | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| Metabolic/Lab, Other (abnormal CO2 ) | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| Metabolic/Lab, Other (abnormal HCT) | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| Metabolic/Lab, Other (abnormal Ketones) | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| Metabolic/Lab, Other (abnormal LDH) | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| Metabolic/Lab, Other(LDH) | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| Mood Alteration (Anxiety) | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Mood Alteration (Depression) | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Mucositis/stomatitis | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Nausea | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Neuropathy (motor) | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Neuropathy (NOS) | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| neuropathy (sensory) | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Ocular, Other (difficulty, L eye) | Eye disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Pain (abdomen) | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Pain (back) | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Pain (chest) | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Pain (flank) | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Pain (joint) | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Pain (muscle) | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Pain (neck) | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Pain (skin) | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Partial Thromboplastin Time (PTT) | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| Phosphorous | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| Proteinuria | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| Pruritis | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Rash/desquamation | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Rigors/chills | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Sensory Neuropathy | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Shingles | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Stomatitis | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Sweating | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Taste alteration | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Tinnitus | Ear and labyrinth disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Urinary frequency | Renal and urinary disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Voice changes | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Vomiting | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| weekness | General disorders | CTCAE (3.0) | Systematic Assessment |
|
The sponsor can review/embargo results communications prior to public release for a period that is >60 days but ≤180 days from date submitted to sponsor, who may require changes to the communication in order to remove specifically identified confidential information (other than study data) and/or delay the proposed publication to enable the sponsor to seek patent protection for inventions. The PI may not publish its results until 18 mos. after the trial has been completed at all sites.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| John D Hainsworth, MD | Sarah Cannon Research Institute | 877-691-7274 | ASKSARAH@scresearch.net |
| ID | Term |
|---|---|
| D007680 | Kidney Neoplasms |
| ID | Term |
|---|---|
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077157 | Sorafenib |
| D000068338 | Everolimus |
| ID | Term |
|---|---|
| D010671 | Phenylurea Compounds |
| D014508 | Urea |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| 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 |
| D020123 | Sirolimus |
| D018942 | Macrolides |
| D007783 | Lactones |
Not provided
Not provided
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|