Trial Outcomes & Findings for Study of Everolimus (RAD001) in Combination With Lenalidomide (NCT NCT01218555)
NCT ID: NCT01218555
Last Updated: 2022-01-27
Results Overview
A standard 3 + 3 design was employed to study escalating doses of daily, orally administered lenalidomide and everolimus. Dose escalation to the next cohort required 0 of 3 or ≤1 of 6 patients with dose-limiting toxicity (DLT). Five dose cohorts were planned starting at dose level one with lenalidomide 10 mg and everolimus 5mg in a 28-day cycle up to maximum doses of 25 and 10 mg, respectively.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
44 participants
Primary outcome timeframe
Within the first 28 days for DLT and throughout the duration of the study for safety.
Results posted on
2022-01-27
Participant Flow
Participant milestones
| Measure |
Dose Level 1 Lenalidomide/Everolimus 10/5 mg
Participants were administered with lenalidomide 10 mg and everolimus 5mg once daily by mouth, every day of each 28-day cycle.
|
Dose Level 2 Lenalidomide/Everolimus
Participants were administered 15/5 of lenalidomide/everolimus once daily by mouth, every day of each 28-day cycle.
|
Dose Level 3: Lenalidomide/Everolimus
Patients were administered 20/5/mg of lenalidomide/everolimus once daily by mouth, every day of each 28-day cycle.
|
Dose Level 4: Lenalidomide/Everolimus 20/5/mg
Participants were administered with lenalidomide 25 mg and everolimus 5mg once daily by mouth, every day of each 28-day cycle.
|
Dose Level 5: Lenalidomide/Everolimus (25/10mg)
Participants were administered with lenalidomide 25 mg and everolimus 10mg once daily by mouth, every day of each 28-day cycle.
|
RP2D: L (25mg) and E (10mg)
Participants were administered with lenalidomide 25 mg and everolimus 10mg once daily by mouth, every day of each 28-day cycle.
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
3
|
5
|
3
|
8
|
22
|
|
Overall Study
COMPLETED
|
3
|
3
|
5
|
3
|
8
|
22
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study of Everolimus (RAD001) in Combination With Lenalidomide
Baseline characteristics by cohort
| Measure |
Lenalidomide Combination With Everolimus
n=44 Participants
Non-randomized study of escalating doses of daily, orally administered lenalidomide in combination with standard doses of everolimus, an orally available mammalian target of rapamycin (mTOR) inhibitor.
Lenalidomide: Lenalidomide (10mg, 15mg, 20mg or 25mg) once daily by mouth, every day of each 28-day cycle.
Everolimus: 5mg or 10mg of everolimus administered once daily by mouth on a once daily continuous dosing schedule for 28 days.
|
|---|---|
|
Age, Continuous
|
58 Years
STANDARD_DEVIATION 44 • n=5 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
28 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
40 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
4 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
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
32 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
|
|
Region of Enrollment
United States
|
44 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Within the first 28 days for DLT and throughout the duration of the study for safety.A standard 3 + 3 design was employed to study escalating doses of daily, orally administered lenalidomide and everolimus. Dose escalation to the next cohort required 0 of 3 or ≤1 of 6 patients with dose-limiting toxicity (DLT). Five dose cohorts were planned starting at dose level one with lenalidomide 10 mg and everolimus 5mg in a 28-day cycle up to maximum doses of 25 and 10 mg, respectively.
Outcome measures
| Measure |
Lenalidomide Combination With Everolimus
n=44 Participants
Non-randomized study of escalating doses of daily, orally administered lenalidomide in combination with standard doses of everolimus, an orally available mammalian target of rapamycin (mTOR) inhibitor.
Lenalidomide: Lenalidomide (10mg, 15mg, 20mg or 25mg) once daily by mouth, every day of each 28-day cycle.
Everolimus: 5mg or 10mg of everolimus administered once daily by mouth on a once daily continuous dosing schedule for 28 days.
|
|---|---|
|
Number of Participants With Dose Limiting Toxicities (DLT) at Each Dose Level
Lenalidomide/everolimus(25/10 mg)
|
8 Participants
|
|
Number of Participants With Dose Limiting Toxicities (DLT) at Each Dose Level
Lenalidomide/everolimus (10/5 mg)
|
3 Participants
|
|
Number of Participants With Dose Limiting Toxicities (DLT) at Each Dose Level
Lenalidomide/everolimus(15/5 mg)
|
3 Participants
|
|
Number of Participants With Dose Limiting Toxicities (DLT) at Each Dose Level
Lenalidomide/everolimus(20/5 mg)
|
5 Participants
|
|
Number of Participants With Dose Limiting Toxicities (DLT) at Each Dose Level
Lenalidomide/everolimus(25/5 mg)
|
3 Participants
|
|
Number of Participants With Dose Limiting Toxicities (DLT) at Each Dose Level
Recommended Phase 2Dose: L (25mg) and E (10mg)
|
22 Participants
|
Adverse Events
Lenalidomide Combination With Everolimus
Serious events: 18 serious events
Other events: 38 other events
Deaths: 18 deaths
Serious adverse events
| Measure |
Lenalidomide Combination With Everolimus
n=44 participants at risk
Adverse Events were collected irrespective of dose administered and it is therefore not possible to report using separate Arms/Groups).
|
|---|---|
|
General disorders
All-Cause Mortality
|
40.9%
18/44 • Adverse events collected through study completion, an average of 1 year.
|
Other adverse events
| Measure |
Lenalidomide Combination With Everolimus
n=44 participants at risk
Adverse Events were collected irrespective of dose administered and it is therefore not possible to report using separate Arms/Groups).
|
|---|---|
|
Gastrointestinal disorders
Anorexia
|
25.0%
11/44 • Adverse events collected through study completion, an average of 1 year.
|
|
Gastrointestinal disorders
Diarrhea
|
29.5%
13/44 • Adverse events collected through study completion, an average of 1 year.
|
|
Gastrointestinal disorders
Nausea
|
25.0%
11/44 • Adverse events collected through study completion, an average of 1 year.
|
|
Metabolism and nutrition disorders
ALT
|
15.9%
7/44 • Adverse events collected through study completion, an average of 1 year.
|
|
General disorders
Fatigue
|
34.1%
15/44 • Adverse events collected through study completion, an average of 1 year.
|
|
Skin and subcutaneous tissue disorders
Rash
|
20.5%
9/44 • Adverse events collected through study completion, an average of 1 year.
|
|
Metabolism and nutrition disorders
Elevated AST
|
11.4%
5/44 • Adverse events collected through study completion, an average of 1 year.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place