Trial Outcomes & Findings for RAD001 in Patients With Metastatic, Hormone-Refractory Prostate Cancer (NCT NCT00629525)
NCT ID: NCT00629525
Last Updated: 2015-03-03
Results Overview
Number of participants with 50% decline in serum PSA from baseline was pre-set as the primary measure of disease response.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
35 participants
Primary outcome timeframe
Patients were followed for a median of 315 days
Results posted on
2015-03-03
Participant Flow
Participant milestones
| Measure |
RAD001
RAD001 at a dose of 10 mg PO daily
|
|---|---|
|
Overall Study
STARTED
|
35
|
|
Overall Study
COMPLETED
|
32
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
RAD001 in Patients With Metastatic, Hormone-Refractory Prostate Cancer
Baseline characteristics by cohort
| Measure |
RAD001
n=35 Participants
RAD001 at a dose of 10 mg PO daily
|
|---|---|
|
Age, Continuous
|
71 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
35 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Patients were followed for a median of 315 daysNumber of participants with 50% decline in serum PSA from baseline was pre-set as the primary measure of disease response.
Outcome measures
| Measure |
RAD001
n=35 Participants
RAD001 at a dose of 10 mg PO daily
|
|---|---|
|
Biochemical Response Rate
|
0 participants
|
SECONDARY outcome
Timeframe: Patients were followed for a median of 315 daysPopulation: Only subjects with paired samples were included in this analysis
Number of participants with either a 50% or greater decrease in proliferation index or a 50% or greater increase in apoptotic index
Outcome measures
| Measure |
RAD001
n=4 Participants
RAD001 at a dose of 10 mg PO daily
|
|---|---|
|
Pathologic Response
|
0 participants
|
SECONDARY outcome
Timeframe: Patients were followed for a median of 315 days, with the last patient censored at 1309 days.Population: Intent to treat
Time in months from the start of study treatment to the date of first progression according to RECIST 1.0, or to death due to any cause. Patients alive who had not progressed as of the last follow-up had PFS censored at the last follow-up date. Median PFS was estimated using a Kaplan-Meier curve.
Outcome measures
| Measure |
RAD001
n=35 Participants
RAD001 at a dose of 10 mg PO daily
|
|---|---|
|
Progression Free Survival
|
3.58 months
Interval 2.07 to 4.83
|
SECONDARY outcome
Timeframe: Patients were followed for a median of 315 daysPopulation: Immunohistochemistry (IHC) for pS6 was compared for 9 pairs of samples for which paraffin embedded tissue was available.
Functional extent of mTOR inhibition by changes in the phosphorylation status of pS6 in prostate tumors.
Outcome measures
| Measure |
RAD001
n=9 Participants
RAD001 at a dose of 10 mg PO daily
|
|---|---|
|
Molecular Response
|
60.11 percentage of decrease
Interval 14.29 to 100.0
|
SECONDARY outcome
Timeframe: Patients were followed for a median of 315 daysThe percentage of participants with a complete or partial response as defined by RECIST 1.0. Response Criteria are defined below: Complete Response: Disappearance of all target lesions Partial Response: At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD Progressive Disease: At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions Stable Disease: Neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum LD
Outcome measures
| Measure |
RAD001
n=35 Participants
RAD001 at a dose of 10 mg PO daily
|
|---|---|
|
Clinical Response
|
0 participants
|
Adverse Events
RAD001
Serious events: 8 serious events
Other events: 35 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
RAD001
n=35 participants at risk
RAD001 at a dose of 10 mg PO daily
|
|---|---|
|
Cardiac disorders
Myocardial infarction
|
2.9%
1/35 • 3 years
data were collected in Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 and converted to version 4.0 for Clinicaltrials.gov entry
|
|
General disorders
Death NOS
|
5.7%
2/35 • 3 years
data were collected in Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 and converted to version 4.0 for Clinicaltrials.gov entry
|
|
Infections and infestations
Sepsis
|
2.9%
1/35 • 3 years
data were collected in Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 and converted to version 4.0 for Clinicaltrials.gov entry
|
|
Investigations
INR increased
|
2.9%
1/35 • 3 years
data were collected in Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 and converted to version 4.0 for Clinicaltrials.gov entry
|
|
Metabolism and nutrition disorders
Dehydration
|
2.9%
1/35 • 3 years
data were collected in Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 and converted to version 4.0 for Clinicaltrials.gov entry
|
|
Nervous system disorders
Nervous system disorders - spinal cord compression
|
2.9%
1/35 • 3 years
data were collected in Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 and converted to version 4.0 for Clinicaltrials.gov entry
|
|
Renal and urinary disorders
Hematuria
|
2.9%
1/35 • 3 years
data were collected in Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 and converted to version 4.0 for Clinicaltrials.gov entry
|
Other adverse events
| Measure |
RAD001
n=35 participants at risk
RAD001 at a dose of 10 mg PO daily
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
40.0%
14/35 • 3 years
data were collected in Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 and converted to version 4.0 for Clinicaltrials.gov entry
|
|
Gastrointestinal disorders
Constipation
|
17.1%
6/35 • 3 years
data were collected in Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 and converted to version 4.0 for Clinicaltrials.gov entry
|
|
Gastrointestinal disorders
Diarrhea
|
31.4%
11/35 • 3 years
data were collected in Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 and converted to version 4.0 for Clinicaltrials.gov entry
|
|
Gastrointestinal disorders
Dry Mouth
|
14.3%
5/35 • 3 years
data were collected in Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 and converted to version 4.0 for Clinicaltrials.gov entry
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify: Mucositis
|
54.3%
19/35 • 3 years
data were collected in Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 and converted to version 4.0 for Clinicaltrials.gov entry
|
|
Gastrointestinal disorders
Mocositis oral
|
5.7%
2/35 • 3 years
data were collected in Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 and converted to version 4.0 for Clinicaltrials.gov entry
|
|
Gastrointestinal disorders
Nausea
|
34.3%
12/35 • 3 years
data were collected in Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 and converted to version 4.0 for Clinicaltrials.gov entry
|
|
Gastrointestinal disorders
Vomiting
|
28.6%
10/35 • 3 years
data were collected in Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 and converted to version 4.0 for Clinicaltrials.gov entry
|
|
General disorders
Chills
|
5.7%
2/35 • 3 years
data were collected in Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 and converted to version 4.0 for Clinicaltrials.gov entry
|
|
General disorders
Edema Limbs
|
5.7%
2/35 • 3 years
data were collected in Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 and converted to version 4.0 for Clinicaltrials.gov entry
|
|
General disorders
Fatigue
|
51.4%
18/35 • 3 years
data were collected in Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 and converted to version 4.0 for Clinicaltrials.gov entry
|
|
General disorders
Facial Pain
|
14.3%
5/35 • 3 years
data were collected in Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 and converted to version 4.0 for Clinicaltrials.gov entry
|
|
General disorders
Fever
|
14.3%
5/35 • 3 years
data were collected in Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 and converted to version 4.0 for Clinicaltrials.gov entry
|
|
General disorders
Non-cardiac chest pain
|
5.7%
2/35 • 3 years
data were collected in Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 and converted to version 4.0 for Clinicaltrials.gov entry
|
|
Investigations
Alanine aminotransferase increased
|
17.1%
6/35 • 3 years
data were collected in Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 and converted to version 4.0 for Clinicaltrials.gov entry
|
|
Investigations
Aspartate aminotransferase increased
|
42.9%
15/35 • 3 years
data were collected in Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 and converted to version 4.0 for Clinicaltrials.gov entry
|
|
Investigations
Cholesterol high
|
31.4%
11/35 • 3 years
data were collected in Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 and converted to version 4.0 for Clinicaltrials.gov entry
|
|
Investigations
Creatinine increased
|
5.7%
2/35 • 3 years
data were collected in Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 and converted to version 4.0 for Clinicaltrials.gov entry
|
|
Investigations
Lymphocyte count decreased
|
8.6%
3/35 • 3 years
data were collected in Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 and converted to version 4.0 for Clinicaltrials.gov entry
|
|
Investigations
Neutrophil count decreased
|
34.3%
12/35 • 3 years
data were collected in Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 and converted to version 4.0 for Clinicaltrials.gov entry
|
|
Investigations
Platelet count decreased
|
48.6%
17/35 • 3 years
data were collected in Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 and converted to version 4.0 for Clinicaltrials.gov entry
|
|
Investigations
Weight loss
|
31.4%
11/35 • 3 years
data were collected in Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 and converted to version 4.0 for Clinicaltrials.gov entry
|
|
Investigations
White blood cell decreased
|
22.9%
8/35 • 3 years
data were collected in Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 and converted to version 4.0 for Clinicaltrials.gov entry
|
|
Metabolism and nutrition disorders
Anorexia
|
48.6%
17/35 • 3 years
data were collected in Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 and converted to version 4.0 for Clinicaltrials.gov entry
|
|
Metabolism and nutrition disorders
Dehydration
|
5.7%
2/35 • 3 years
data were collected in Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 and converted to version 4.0 for Clinicaltrials.gov entry
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
8.6%
3/35 • 3 years
data were collected in Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 and converted to version 4.0 for Clinicaltrials.gov entry
|
|
Metabolism and nutrition disorders
Hypertriglyceridemia
|
48.6%
17/35 • 3 years
data were collected in Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 and converted to version 4.0 for Clinicaltrials.gov entry
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
17.1%
6/35 • 3 years
data were collected in Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 and converted to version 4.0 for Clinicaltrials.gov entry
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
5.7%
2/35 • 3 years
data were collected in Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 and converted to version 4.0 for Clinicaltrials.gov entry
|
|
Metabolism and nutrition disorders
Hypokalemia
|
8.6%
3/35 • 3 years
data were collected in Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 and converted to version 4.0 for Clinicaltrials.gov entry
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
5.7%
2/35 • 3 years
data were collected in Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 and converted to version 4.0 for Clinicaltrials.gov entry
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
5.7%
2/35 • 3 years
data were collected in Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 and converted to version 4.0 for Clinicaltrials.gov entry
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
5.7%
2/35 • 3 years
data were collected in Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 and converted to version 4.0 for Clinicaltrials.gov entry
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
14.3%
5/35 • 3 years
data were collected in Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 and converted to version 4.0 for Clinicaltrials.gov entry
|
|
Nervous system disorders
Dizziness
|
8.6%
3/35 • 3 years
data were collected in Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 and converted to version 4.0 for Clinicaltrials.gov entry
|
|
Nervous system disorders
Dysgeusia
|
25.7%
9/35 • 3 years
data were collected in Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 and converted to version 4.0 for Clinicaltrials.gov entry
|
|
Nervous system disorders
Headache
|
11.4%
4/35 • 3 years
data were collected in Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 and converted to version 4.0 for Clinicaltrials.gov entry
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.7%
2/35 • 3 years
data were collected in Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 and converted to version 4.0 for Clinicaltrials.gov entry
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
20.0%
7/35 • 3 years
data were collected in Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 and converted to version 4.0 for Clinicaltrials.gov entry
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
8.6%
3/35 • 3 years
data were collected in Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 and converted to version 4.0 for Clinicaltrials.gov entry
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
8.6%
3/35 • 3 years
data were collected in Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 and converted to version 4.0 for Clinicaltrials.gov entry
|
|
Respiratory, thoracic and mediastinal disorders
Sinus disorder
|
5.7%
2/35 • 3 years
data were collected in Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 and converted to version 4.0 for Clinicaltrials.gov entry
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
20.0%
7/35 • 3 years
data were collected in Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 and converted to version 4.0 for Clinicaltrials.gov entry
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
5.7%
2/35 • 3 years
data were collected in Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 and converted to version 4.0 for Clinicaltrials.gov entry
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
37.1%
13/35 • 3 years
data were collected in Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 and converted to version 4.0 for Clinicaltrials.gov entry
|
|
Vascular disorders
Hypotension
|
5.7%
2/35 • 3 years
data were collected in Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 and converted to version 4.0 for Clinicaltrials.gov entry
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place