Trial Outcomes & Findings for Lenalidomide in Treating Patients With Advanced or Unresectable Kidney Cancer (NCT NCT00403169)
NCT ID: NCT00403169
Last Updated: 2026-07-02
Results Overview
The objective response rate was defined by RECIST.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
28 participants
Primary outcome timeframe
Baseline and every 2 weeks until study completion, up to 1.5 years
Results posted on
2026-07-02
Participant Flow
Participant milestones
| Measure |
Lenalidomide for Advanced RCC
25 mg/day Lenalidomide for 21-days per 28-day cycle.
lenalidomide: drug
|
|---|---|
|
Overall Study
STARTED
|
28
|
|
Overall Study
COMPLETED
|
28
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Lenalidomide in Treating Patients With Advanced or Unresectable Kidney Cancer
Baseline characteristics by cohort
| Measure |
Lenalidomide for Advanced RCC
n=28 Participants
25 mg/day Lenalidomide for 21-days per 28-day cycle.
lenalidomide: drug
|
|---|---|
|
Age, Continuous
|
63.5 years
STANDARD_DEVIATION 9.3 • n=20 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=20 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=20 Participants
|
PRIMARY outcome
Timeframe: Baseline and every 2 weeks until study completion, up to 1.5 yearsThe objective response rate was defined by RECIST.
Outcome measures
| Measure |
Lenalidomide for Advanced RCC
n=28 Participants
25 mg/day Lenalidomide for 21-days per 28-day cycle.
lenalidomide: drug
|
|---|---|
|
Objective Response Rate
|
3 Participants
|
SECONDARY outcome
Timeframe: Baseline and every 2 weeks until study completion. Number of cycles is open ended.Most commonly reported Serious Adverse Events
Outcome measures
| Measure |
Lenalidomide for Advanced RCC
n=28 Participants
25 mg/day Lenalidomide for 21-days per 28-day cycle.
lenalidomide: drug
|
|---|---|
|
Toxicity--Most Common AEs
Fatigue
|
11 percentage of participants
|
|
Toxicity--Most Common AEs
Skin Toxicity
|
11 percentage of participants
|
|
Toxicity--Most Common AEs
Neutropenia
|
36 percentage of participants
|
SECONDARY outcome
Timeframe: 1 to 16 cycles, until patient expires, is lost to follow up or withdraws consentPopulation: 17 patients were alive at time of analysis
Outcome measures
| Measure |
Lenalidomide for Advanced RCC
n=28 Participants
25 mg/day Lenalidomide for 21-days per 28-day cycle.
lenalidomide: drug
|
|---|---|
|
Overall Survival
|
17 Participants
|
Adverse Events
Lenalidomide for Advanced RCC
Serious events: 16 serious events
Other events: 28 other events
Deaths: 11 deaths
Serious adverse events
| Measure |
Lenalidomide for Advanced RCC
n=28 participants at risk
25 mg/day Lenalidomide for 21-days per 28-day cycle.
lenalidomide: drug
|
|---|---|
|
General disorders
Fatigue
|
10.7%
3/28
|
|
Blood and lymphatic system disorders
Neutropenia
|
35.7%
10/28
|
|
Skin and subcutaneous tissue disorders
Skin Reaction
|
10.7%
3/28
|
Other adverse events
| Measure |
Lenalidomide for Advanced RCC
n=28 participants at risk
25 mg/day Lenalidomide for 21-days per 28-day cycle.
lenalidomide: drug
|
|---|---|
|
General disorders
Fatigue
|
75.0%
21/28
|
|
Skin and subcutaneous tissue disorders
Skin Reactions
|
57.1%
16/28
|
|
Gastrointestinal disorders
Constipation
|
28.6%
8/28
|
|
Gastrointestinal disorders
Diarrhea
|
28.6%
8/28
|
|
Nervous system disorders
Neuropathy
|
10.7%
3/28
|
|
General disorders
Edema
|
21.4%
6/28
|
|
Gastrointestinal disorders
Nausea/Emesis
|
35.7%
10/28
|
|
Respiratory, thoracic and mediastinal disorders
Cough/Dyspnea
|
14.3%
4/28
|
|
General disorders
Dizziness
|
14.3%
4/28
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place