Trial Outcomes & Findings for Everolimus (RAD001) For Advanced Renal Cell Carcinoma (RCC) Before Kidney Removal (NCT NCT00831480)
NCT ID: NCT00831480
Last Updated: 2016-03-21
Results Overview
Clinical progression validated by biopsy of metastatic site. Progression-free survival (PFS) will be measured from the post-op treatment start date to either the date the patient is first recorded as having disease progression, or the date of death if the patient dies due to any causes before progression. If a patient is lost to follow-up or removed for toxicities, the patient will be censored as of the last date of contact. Patients who start a new treatment before they progress will be censored as of the date of start of the new treatment. If a patient has not progressed or died, PFS is censored at the date of last follow-up. Patients removed from therapy with everolimus due to toxicities will not be included in the PFS estimation.
TERMINATED
PHASE2
15 participants
up to one year
2016-03-21
Participant Flow
Fifteen subjects signed informed consents. Out of that 15, 9 took at least one dose of study drug.
Participant milestones
| Measure |
Neoadjuvant Everolimus "RAD001" for Advanced RCC Before Cytore
All subjects will take everolimus
everolimus: everolimus 10 mg PO once daily for 3-5 weeks followed by removal of the kidney. Everolimus will begin again between 2 to 4 weeks after surgery.
|
|---|---|
|
Overall Study
STARTED
|
9
|
|
Overall Study
COMPLETED
|
7
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Everolimus (RAD001) For Advanced Renal Cell Carcinoma (RCC) Before Kidney Removal
Baseline characteristics by cohort
| Measure |
Neoadjuvant Everolimus "RAD001" for Advanced RCC Before Cytore
n=9 Participants
All subjects will take everolimus
everolimus: everolimus 10 mg PO once daily for 3-5 weeks followed by removal of the kidney. Everolimus will begin again between 2 to 4 weeks after surgery.
|
|---|---|
|
Age, Continuous
|
58.9 years
n=5 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
7 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
8 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
9 participants
n=5 Participants
|
|
Evidence of Metastatic Disease
|
9 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: up to one yearClinical progression validated by biopsy of metastatic site. Progression-free survival (PFS) will be measured from the post-op treatment start date to either the date the patient is first recorded as having disease progression, or the date of death if the patient dies due to any causes before progression. If a patient is lost to follow-up or removed for toxicities, the patient will be censored as of the last date of contact. Patients who start a new treatment before they progress will be censored as of the date of start of the new treatment. If a patient has not progressed or died, PFS is censored at the date of last follow-up. Patients removed from therapy with everolimus due to toxicities will not be included in the PFS estimation.
Outcome measures
| Measure |
Neoadjuvant Everolimus "RAD001" for Advanced RCC Before Cytore
n=9 Participants
All subjects will take everolimus
everolimus: everolimus 10 mg PO once daily for 3-5 weeks followed by removal of the kidney. Everolimus will begin again between 2 to 4 weeks after surgery.
|
|---|---|
|
Disease Progression Diagnosed by Biopsy
|
9 participants
|
Adverse Events
Neoadjuvant Everolimus "RAD001" for Advanced RCC Before Cytore
Serious adverse events
| Measure |
Neoadjuvant Everolimus "RAD001" for Advanced RCC Before Cytore
n=9 participants at risk
All subjects will take everolimus
everolimus: everolimus 10 mg PO once daily for 3-5 weeks followed by removal of the kidney. Everolimus will begin again between 2 to 4 weeks after surgery.
|
|---|---|
|
Surgical and medical procedures
Kidney Injury
|
11.1%
1/9 • Number of events 1
|
Other adverse events
| Measure |
Neoadjuvant Everolimus "RAD001" for Advanced RCC Before Cytore
n=9 participants at risk
All subjects will take everolimus
everolimus: everolimus 10 mg PO once daily for 3-5 weeks followed by removal of the kidney. Everolimus will begin again between 2 to 4 weeks after surgery.
|
|---|---|
|
Skin and subcutaneous tissue disorders
mucositis of tongue
|
66.7%
6/9 • Number of events 6
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place