Clinical trial · Interventional
Dosing and Effectiveness Study of Sorafenib and RAD001 in the Treatment of Patients With Advanced Kidney Cancer
Phase I/II Trial of Sorafenib (Nexavar) and RAD001 (Everolimus)in the Treatment of Patients With Advanced Clear Cell Renal Cell Carcinoma
NCT00392821CI-TRIAL-00058917completedPhase 1 / Phase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Kidney Cancer | Malignant Kidney Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| RAD001 | Drug | Everolimus | ALIAS |
| Sorafenib | Drug | Sorafenib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- RAD001 and Sorafenib
- description
- RAD001 and Sorafenib
- interventionNames
- Drug: Sorafenib
- Drug: RAD001
Primary outcomes (1)
- measure
- Overall Response Rate (ORR) of Patients Treated at MTD/Phase II Dose Level
- timeFrame
- 18 months
- description
- 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.
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Clinically documented metastatic or unresectable locally recurrent clear cell renal carcinoma * Previous removal of kidney except if the size of the tumor was less than 5 cm or there was extensive liver or bone metastasis * May have had no prior chemotherapy or up to 1 prior treatment regimen with immunotherapy or chemotherapy * Performance status of 0-1 * Measurable disease * Adequate liver, renal, and bone marrow function * Must be able to give written informed consent * Women able to become pregnant must have a negative pregnancy test * Must be 18 or over * Must be able to swallow pills Exclusion Criteria: * Prior treatment with sorafenib or m-TOR inhibitors * History of acute MI within the last 6 months * Active brain metastasis or patients with meningeal metastases * Prior treatment for another cancer in the last 5 years * Prior bleeding problems; coughing up or vomiting blood * Non-healing wounds, ulcer, or long bone fracture * Chronic use of systemic steroids or immunosuppressive agents * Uncontrolled hypertension 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.
References
Publications (0)
Data not yet available
No reference posted for this study.