Trial Outcomes & Findings for Study Evaluating Toxicity & Efficacy of Lenalidomide(Revlimid®)in Chemotherapy-Naïve AIPC Patients (NCT NCT00654186)
NCT ID: NCT00654186
Last Updated: 2014-03-28
Results Overview
The OCB was assessed using Recist 1.0 as defined in the protocol. A CR was defined as the disappearance of all lesions. A PR was defined as \> or equal to a 30% decrease in the sum of the longest diameter of measureable lesions, SD was defined \< a 30% decrease in the sum of the longest diameter of measureable lesions and \< a 20% increase in the sum of the longest diameter of measureable lesions. For a CR, PR or SD, there are no new lesions. Prostate-Specific Antigen (PSA) was also evaluated. A PSA CR was a PSA \< or equal to 4 ng/dl. A PSA PR was a PSA that decreased by \> or equal to 50%. Stable PSA was defined as a PSA that increased \>25% and decreased \< 50%.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
32 participants
Primary outcome timeframe
24 months for acrual
Results posted on
2014-03-28
Participant Flow
Participant milestones
| Measure |
Revlimid Oral for 21days
Revlimid: 25mg by mouth daily on days 1 - 21 followed by 7 days of rest repeated every 28 days
|
|---|---|
|
Overall Study
STARTED
|
32
|
|
Overall Study
COMPLETED
|
27
|
|
Overall Study
NOT COMPLETED
|
5
|
Reasons for withdrawal
| Measure |
Revlimid Oral for 21days
Revlimid: 25mg by mouth daily on days 1 - 21 followed by 7 days of rest repeated every 28 days
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
5
|
Baseline Characteristics
Study Evaluating Toxicity & Efficacy of Lenalidomide(Revlimid®)in Chemotherapy-Naïve AIPC Patients
Baseline characteristics by cohort
| Measure |
Revlimid Oral for 21days
n=32 Participants
Revlimid: 25mg by mouth daily on days 1 - 21 followed by 7 days of rest repeated every 28 days
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
8 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
24 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
32 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
32 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 24 months for acrualPopulation: evaluable patients
The OCB was assessed using Recist 1.0 as defined in the protocol. A CR was defined as the disappearance of all lesions. A PR was defined as \> or equal to a 30% decrease in the sum of the longest diameter of measureable lesions, SD was defined \< a 30% decrease in the sum of the longest diameter of measureable lesions and \< a 20% increase in the sum of the longest diameter of measureable lesions. For a CR, PR or SD, there are no new lesions. Prostate-Specific Antigen (PSA) was also evaluated. A PSA CR was a PSA \< or equal to 4 ng/dl. A PSA PR was a PSA that decreased by \> or equal to 50%. Stable PSA was defined as a PSA that increased \>25% and decreased \< 50%.
Outcome measures
| Measure |
Revlimid Oral for 21days
n=27 Participants
Revlimid: 25mg by mouth daily on days 1 - 21 followed by 7 days of rest repeated every 28 days
|
|---|---|
|
Number of Participants With Overall Clinical Benefit (OCB), Defined as the Sum of Complete Response (CR), Partial Response (PR), and Stable Disease (SD) Divided by the Number of Participants
|
74 percentage of patients
|
SECONDARY outcome
Timeframe: 24 months for acrualAs defined in the protocol PSA progression was an increase of at least 25%
Outcome measures
| Measure |
Revlimid Oral for 21days
n=27 Participants
Revlimid: 25mg by mouth daily on days 1 - 21 followed by 7 days of rest repeated every 28 days
|
|---|---|
|
Time to PSA Progression
|
3 months
Interval 2.0 to 11.0
|
SECONDARY outcome
Timeframe: 24 monthsProgressive disease (PD) was determined, as outlined in the protocol, by using Recist 1.0. PD is defined as greater than or equal to a 20% increase in the sum of all measureable lesions or the apprearance of two new bone lesions or the appearnce of one new soft tissue lesion.
Outcome measures
| Measure |
Revlimid Oral for 21days
n=27 Participants
Revlimid: 25mg by mouth daily on days 1 - 21 followed by 7 days of rest repeated every 28 days
|
|---|---|
|
Time to Disesase Progression as Measured by Radiographic Progression
|
4 months
Interval 2.0 to 16.0
|
Adverse Events
Revlimid Orally for 21 Days
Serious events: 14 serious events
Other events: 32 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Revlimid Orally for 21 Days
n=32 participants at risk
Revlimid: 25mg daily on days 1 - 21 followed by 7 days of rest repeated every 28 days
|
|---|---|
|
Nervous system disorders
syncope
|
6.2%
2/32 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
respiratory failure
|
3.1%
1/32 • Number of events 1
|
|
Cardiac disorders
atrial fibrilation
|
6.2%
2/32 • Number of events 2
|
|
Infections and infestations
sepsis
|
3.1%
1/32 • Number of events 1
|
|
Gastrointestinal disorders
pancreatitis
|
3.1%
1/32 • Number of events 1
|
|
Hepatobiliary disorders
cholecystitis
|
3.1%
1/32 • Number of events 1
|
|
Renal and urinary disorders
renal failure
|
3.1%
1/32 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
rash
|
3.1%
1/32 • Number of events 1
|
|
Renal and urinary disorders
kidney stones
|
3.1%
1/32 • Number of events 1
|
|
Infections and infestations
bronchitis
|
3.1%
1/32 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
pulmonary embolism
|
6.2%
2/32 • Number of events 2
|
|
Gastrointestinal disorders
dehydration
|
12.5%
4/32 • Number of events 4
|
|
General disorders
weakness
|
3.1%
1/32 • Number of events 1
|
|
General disorders
pancytopenia
|
3.1%
1/32 • Number of events 1
|
|
Cardiac disorders
myocardial infarction
|
3.1%
1/32 • Number of events 1
|
|
Gastrointestinal disorders
rectal abcess
|
3.1%
1/32 • Number of events 1
|
|
Renal and urinary disorders
Hematuria
|
6.2%
2/32 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
exacerbation of chronic obstructive pulmonary disorder
|
3.1%
1/32 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Shortness of breath
|
3.1%
1/32 • Number of events 1
|
|
Blood and lymphatic system disorders
diverticulitis
|
3.1%
1/32 • Number of events 1
|
Other adverse events
| Measure |
Revlimid Orally for 21 Days
n=32 participants at risk
Revlimid: 25mg daily on days 1 - 21 followed by 7 days of rest repeated every 28 days
|
|---|---|
|
Hepatobiliary disorders
aspartate aminotransferase increased
|
21.9%
7/32
|
|
Cardiac disorders
atrial fibrilation
|
6.2%
2/32
|
|
Gastrointestinal disorders
albumin low
|
62.5%
20/32
|
|
Blood and lymphatic system disorders
anemia
|
68.8%
22/32
|
|
Psychiatric disorders
anxiety
|
28.1%
9/32
|
|
Gastrointestinal disorders
anorexia
|
50.0%
16/32
|
|
Musculoskeletal and connective tissue disorders
arthalgia
|
21.9%
7/32
|
|
Hepatobiliary disorders
alanine aminotransferase
|
18.8%
6/32
|
|
Hepatobiliary disorders
Alkaline phosphatase
|
28.1%
9/32
|
|
Musculoskeletal and connective tissue disorders
back pain
|
21.9%
7/32
|
|
Blood and lymphatic system disorders
bruises easily
|
25.0%
8/32
|
|
Blood and lymphatic system disorders
bleeds easily
|
6.2%
2/32
|
|
Renal and urinary disorders
bilirubin increased
|
6.2%
2/32
|
|
General disorders
bloating
|
9.4%
3/32
|
|
Gastrointestinal disorders
constipation
|
90.6%
29/32
|
|
Renal and urinary disorders
creatinine increased
|
18.8%
6/32
|
|
Cardiac disorders
congestive heart failure
|
6.2%
2/32
|
|
Respiratory, thoracic and mediastinal disorders
cough
|
9.4%
3/32
|
|
Musculoskeletal and connective tissue disorders
cramps
|
6.2%
2/32
|
|
General disorders
chills
|
15.6%
5/32
|
|
Gastrointestinal disorders
diarrhea
|
25.0%
8/32
|
|
Gastrointestinal disorders
diverticulitis
|
9.4%
3/32
|
|
Psychiatric disorders
depression
|
31.2%
10/32
|
|
General disorders
dizziness
|
9.4%
3/32
|
|
Respiratory, thoracic and mediastinal disorders
dyspnea on exertion
|
15.6%
5/32
|
|
Gastrointestinal disorders
dehydration
|
18.8%
6/32
|
|
Eye disorders
eyes dry
|
9.4%
3/32
|
|
General disorders
edema
|
21.9%
7/32
|
|
Eye disorders
eyes watery
|
9.4%
3/32
|
|
General disorders
fatigue
|
71.9%
23/32
|
|
General disorders
gynecomastia
|
9.4%
3/32
|
|
General disorders
globulin low
|
6.2%
2/32
|
|
Metabolism and nutrition disorders
hyperkalemia
|
12.5%
4/32
|
|
Endocrine disorders
hypoglycemia
|
6.2%
2/32
|
|
Endocrine disorders
hyperglycemia
|
40.6%
13/32
|
|
Metabolism and nutrition disorders
hypokalemia
|
21.9%
7/32
|
|
Renal and urinary disorders
hematuria
|
12.5%
4/32
|
|
Metabolism and nutrition disorders
hypotremia
|
25.0%
8/32
|
|
General disorders
headache
|
9.4%
3/32
|
|
Metabolism and nutrition disorders
hypocalcemia
|
37.5%
12/32 • Number of events 12
|
|
Reproductive system and breast disorders
hot flashes
|
6.2%
2/32
|
|
Cardiac disorders
hypertension
|
6.2%
2/32
|
|
Musculoskeletal and connective tissue disorders
hip pain
|
6.2%
2/32
|
|
Skin and subcutaneous tissue disorders
itching
|
9.4%
3/32
|
|
General disorders
insomnia
|
15.6%
5/32
|
|
Blood and lymphatic system disorders
leukopenia
|
56.2%
18/32
|
|
Reproductive system and breast disorders
libido decreased
|
12.5%
4/32
|
|
General disorders
lightheadedness
|
15.6%
5/32
|
|
Blood and lymphatic system disorders
lymphopenia
|
37.5%
12/32
|
|
General disorders
leg weakness
|
6.2%
2/32
|
|
Gastrointestinal disorders
mouth dry
|
12.5%
4/32
|
|
Gastrointestinal disorders
mouth sores
|
6.2%
2/32
|
|
Blood and lymphatic system disorders
neutropenia
|
56.2%
18/32
|
|
Gastrointestinal disorders
nausea
|
21.9%
7/32
|
|
Musculoskeletal and connective tissue disorders
neck sore
|
6.2%
2/32
|
|
Nervous system disorders
neuropathy motor
|
21.9%
7/32
|
|
Nervous system disorders
neuropathy sensory
|
9.4%
3/32
|
|
General disorders
pain
|
15.6%
5/32
|
|
Respiratory, thoracic and mediastinal disorders
pulmonary emboli
|
6.2%
2/32
|
|
Skin and subcutaneous tissue disorders
rash
|
37.5%
12/32
|
|
Renal and urinary disorders
renal insufficiency
|
9.4%
3/32
|
|
Respiratory, thoracic and mediastinal disorders
shortness of breath
|
18.8%
6/32
|
|
General disorders
syncope
|
6.2%
2/32
|
|
Musculoskeletal and connective tissue disorders
shoulder pain
|
9.4%
3/32
|
|
Skin and subcutaneous tissue disorders
skin dry
|
18.8%
6/32
|
|
Gastrointestinal disorders
taste changes
|
18.8%
6/32
|
|
Blood and lymphatic system disorders
thrombocytopenia
|
62.5%
20/32
|
|
Cardiac disorders
tachycardia
|
15.6%
5/32
|
|
General disorders
throat sore
|
9.4%
3/32
|
|
Infections and infestations
unrinary tract infection
|
9.4%
3/32
|
|
Renal and urinary disorders
urinary frequency increased
|
9.4%
3/32
|
|
General disorders
weight loss
|
34.4%
11/32
|
|
Respiratory, thoracic and mediastinal disorders
wheezing
|
6.2%
2/32
|
|
General disorders
weakness
|
15.6%
5/32
|
|
Gastrointestinal disorders
vomiting
|
15.6%
5/32
|
|
Eye disorders
vision problems
|
6.2%
2/32
|
|
Eye disorders
vision changes
|
9.4%
3/32
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place