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
2 other identifiers
interventional
78
1 country
11
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Dec 2006
Longer than P75 for phase_1
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 25, 2006
CompletedFirst Posted
Study publicly available on registry
October 26, 2006
CompletedStudy Start
First participant enrolled
December 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2013
CompletedResults Posted
Study results publicly available
March 26, 2014
CompletedJune 6, 2022
May 1, 2022
6.8 years
October 25, 2006
February 10, 2014
May 10, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (1)
Progression-Free Survival for Patients Treated at MTD/Phase II Dose Level
18 months
Study Arms (1)
RAD001 and Sorafenib
EXPERIMENTALRAD001 and Sorafenib
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- SCRI Development Innovations, LLClead
- Novartiscollaborator
- Bayercollaborator
Study Sites (11)
Florida Hospital Cancer Institute
Orlando, Florida, 32804, United States
Northeast Georgia Medical Center
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
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- John D Hainsworth, MD
- Organization
- Sarah Cannon Research Institute
Study Officials
- PRINCIPAL INVESTIGATOR
John D Hainsworth, MD
SCRI Development Innovations, LLC
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 25, 2006
First Posted
October 26, 2006
Study Start
December 1, 2006
Primary Completion
October 1, 2013
Study Completion
October 1, 2013
Last Updated
June 6, 2022
Results First Posted
March 26, 2014
Record last verified: 2022-05