Trial Outcomes & Findings for Pasireotide (SOM230) With or Without Everolimus in Treating Patients With Hormone Resistant, Chemotherapy Naive Prostate Cancer (NCT NCT01313559)
NCT ID: NCT01313559
Last Updated: 2025-04-30
Results Overview
Progression of disease is defined as disease progression by RECIST 1.1 criteria on CT scan (X-ray computed tomography), or appearance of \> 2 new bone lesions on bone scan, or prostate-specific antigen (PSA) progression by Prostate Cancer Clinical Trials Working Group (PCWG2) criteria or death from any cause.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
6 participants
Primary outcome timeframe
12 weeks after treatment
Results posted on
2025-04-30
Participant Flow
Participant milestones
| Measure |
Cohort A (Pasireotide)
Patients receive pasireotide IM once every 4 weeks
Pasireotide: Given IM
Laboratory biomarker analysis: Correlative studies
|
Cohort B (Pasireotide and Everolimus)
Patients receive pasireotide as in cohort A and everolimus PO QD
Pasireotide: Given IM
Everolimus: Given PO
Laboratory biomarker analysis: Correlative studies
|
|---|---|---|
|
Overall Study
STARTED
|
4
|
2
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
4
|
2
|
Reasons for withdrawal
| Measure |
Cohort A (Pasireotide)
Patients receive pasireotide IM once every 4 weeks
Pasireotide: Given IM
Laboratory biomarker analysis: Correlative studies
|
Cohort B (Pasireotide and Everolimus)
Patients receive pasireotide as in cohort A and everolimus PO QD
Pasireotide: Given IM
Everolimus: Given PO
Laboratory biomarker analysis: Correlative studies
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
2
|
|
Overall Study
Disease progression
|
1
|
0
|
|
Overall Study
Rising PSA
|
2
|
0
|
Baseline Characteristics
Pasireotide (SOM230) With or Without Everolimus in Treating Patients With Hormone Resistant, Chemotherapy Naive Prostate Cancer
Baseline characteristics by cohort
| Measure |
Cohort A (Pasireotide)
n=4 Participants
Patients receive pasireotide IM once every 4 weeks
Pasireotide: Given IM
Laboratory biomarker analysis: Correlative studies
|
Cohort B (Pasireotide and Everolimus)
n=2 Participants
Patients receive pasireotide as in cohort A and everolimus PO QD
Pasireotide: Given IM
Everolimus: Given PO
Laboratory biomarker analysis: Correlative studies
|
Total
n=6 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Age, Continuous
|
78.0 years
STANDARD_DEVIATION 4.6 • n=5 Participants
|
69.4 years
STANDARD_DEVIATION 8.4 • n=7 Participants
|
75.2 years
STANDARD_DEVIATION 6.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
4 participants
n=5 Participants
|
2 participants
n=7 Participants
|
6 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 weeks after treatmentProgression of disease is defined as disease progression by RECIST 1.1 criteria on CT scan (X-ray computed tomography), or appearance of \> 2 new bone lesions on bone scan, or prostate-specific antigen (PSA) progression by Prostate Cancer Clinical Trials Working Group (PCWG2) criteria or death from any cause.
Outcome measures
| Measure |
Cohort A (Pasireotide)
n=4 Participants
Patients receive pasireotide IM once every 4 weeks
Pasireotide: Given IM
Laboratory biomarker analysis: Correlative studies
|
Cohort B (Pasireotide and Everolimus)
n=2 Participants
Patients receive pasireotide as in cohort A and everolimus PO QD
Pasireotide: Given IM
Everolimus: Given PO
Laboratory biomarker analysis: Correlative studies
|
|---|---|---|
|
Number of Participants Alive and Progression Free After 12 Weeks of Treatment
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: After 12 weeks of treatmentOutcome measures
| Measure |
Cohort A (Pasireotide)
n=4 Participants
Patients receive pasireotide IM once every 4 weeks
Pasireotide: Given IM
Laboratory biomarker analysis: Correlative studies
|
Cohort B (Pasireotide and Everolimus)
n=2 Participants
Patients receive pasireotide as in cohort A and everolimus PO QD
Pasireotide: Given IM
Everolimus: Given PO
Laboratory biomarker analysis: Correlative studies
|
|---|---|---|
|
Number of Participants With > 50% Decline From Baseline PSA Level
|
2 participants
|
0 participants
|
SECONDARY outcome
Timeframe: After 12 weeks of treatmentOutcome measures
| Measure |
Cohort A (Pasireotide)
n=4 Participants
Patients receive pasireotide IM once every 4 weeks
Pasireotide: Given IM
Laboratory biomarker analysis: Correlative studies
|
Cohort B (Pasireotide and Everolimus)
n=2 Participants
Patients receive pasireotide as in cohort A and everolimus PO QD
Pasireotide: Given IM
Everolimus: Given PO
Laboratory biomarker analysis: Correlative studies
|
|---|---|---|
|
Number of Participants Without New Bone Lesions After 12 Weeks of Treatment
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Assessed up to 30 days after completion of study treatmentProgression free survival (PFS) based on primary outcome criteria for disease progression. Patients without radiographic disease progression who permanently discontinue the study drugs will be censored
Outcome measures
| Measure |
Cohort A (Pasireotide)
n=4 Participants
Patients receive pasireotide IM once every 4 weeks
Pasireotide: Given IM
Laboratory biomarker analysis: Correlative studies
|
Cohort B (Pasireotide and Everolimus)
n=2 Participants
Patients receive pasireotide as in cohort A and everolimus PO QD
Pasireotide: Given IM
Everolimus: Given PO
Laboratory biomarker analysis: Correlative studies
|
|---|---|---|
|
Number of Participants With Progression Free Survival (PFS) Based on RECIST 1.1 Criteria
|
0 participants
|
0 participants
|
Adverse Events
Cohort A (Pasireotide)
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
Cohort B (Pasireotide and Everolimus)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cohort A (Pasireotide)
n=4 participants at risk
Patients receive pasireotide IM once every 4 weeks
Pasireotide: Given IM
Laboratory biomarker analysis: Correlative studies
|
Cohort B (Pasireotide and Everolimus)
n=2 participants at risk
Patients receive pasireotide as in cohort A and everolimus PO QD
Pasireotide: Given IM
Everolimus: Given PO
Laboratory biomarker analysis: Correlative studies
|
|---|---|---|
|
Blood and lymphatic system disorders
Elevated creatinine
|
25.0%
1/4 • Number of events 1
|
0.00%
0/2
|
|
Renal and urinary disorders
Urinary tract obstruction
|
25.0%
1/4 • Number of events 1
|
0.00%
0/2
|
Other adverse events
| Measure |
Cohort A (Pasireotide)
n=4 participants at risk
Patients receive pasireotide IM once every 4 weeks
Pasireotide: Given IM
Laboratory biomarker analysis: Correlative studies
|
Cohort B (Pasireotide and Everolimus)
n=2 participants at risk
Patients receive pasireotide as in cohort A and everolimus PO QD
Pasireotide: Given IM
Everolimus: Given PO
Laboratory biomarker analysis: Correlative studies
|
|---|---|---|
|
General disorders
Abdominal pain
|
25.0%
1/4 • Number of events 1
|
0.00%
0/2
|
|
Blood and lymphatic system disorders
Anemia
|
25.0%
1/4 • Number of events 1
|
0.00%
0/2
|
|
General disorders
Anorexia
|
50.0%
2/4 • Number of events 2
|
50.0%
1/2 • Number of events 1
|
|
General disorders
Chest discomfort
|
25.0%
1/4 • Number of events 1
|
0.00%
0/2
|
|
General disorders
Chills
|
0.00%
0/4
|
50.0%
1/2 • Number of events 2
|
|
Gastrointestinal disorders
Constipation
|
25.0%
1/4 • Number of events 1
|
50.0%
1/2 • Number of events 1
|
|
General disorders
Cough
|
25.0%
1/4 • Number of events 1
|
50.0%
1/2 • Number of events 1
|
|
General disorders
Decreased appetite
|
0.00%
0/4
|
50.0%
1/2 • Number of events 1
|
|
General disorders
Dehydration
|
50.0%
2/4 • Number of events 3
|
50.0%
1/2 • Number of events 1
|
|
Gastrointestinal disorders
Diarrhea
|
50.0%
2/4 • Number of events 2
|
50.0%
1/2 • Number of events 2
|
|
General disorders
Dizziness
|
50.0%
2/4 • Number of events 3
|
0.00%
0/2
|
|
General disorders
Dry mouth
|
25.0%
1/4 • Number of events 1
|
50.0%
1/2 • Number of events 1
|
|
General disorders
Dry skin
|
0.00%
0/4
|
50.0%
1/2 • Number of events 1
|
|
General disorders
Dysgeusia
|
0.00%
0/4
|
50.0%
1/2 • Number of events 1
|
|
Gastrointestinal disorders
Dyspepsia
|
25.0%
1/4 • Number of events 1
|
0.00%
0/2
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
25.0%
1/4 • Number of events 1
|
0.00%
0/2
|
|
Blood and lymphatic system disorders
Elevated creatinine
|
0.00%
0/4
|
50.0%
1/2 • Number of events 2
|
|
Blood and lymphatic system disorders
Elevated transaminase
|
0.00%
0/4
|
50.0%
1/2 • Number of events 1
|
|
General disorders
Fall
|
25.0%
1/4 • Number of events 1
|
0.00%
0/2
|
|
General disorders
Fatigue
|
75.0%
3/4 • Number of events 3
|
100.0%
2/2 • Number of events 4
|
|
General disorders
Flatulence
|
50.0%
2/4 • Number of events 2
|
0.00%
0/2
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
25.0%
1/4 • Number of events 1
|
0.00%
0/2
|
|
General disorders
Headache
|
75.0%
3/4 • Number of events 4
|
0.00%
0/2
|
|
Renal and urinary disorders
Hematuria
|
25.0%
1/4 • Number of events 1
|
0.00%
0/2
|
|
General disorders
Hip pain
|
0.00%
0/4
|
50.0%
1/2 • Number of events 1
|
|
General disorders
Hot flashes
|
25.0%
1/4 • Number of events 1
|
0.00%
0/2
|
|
Blood and lymphatic system disorders
Hyperglycemia
|
75.0%
3/4 • Number of events 5
|
100.0%
2/2 • Number of events 6
|
|
Blood and lymphatic system disorders
Hypertension
|
25.0%
1/4 • Number of events 1
|
0.00%
0/2
|
|
Blood and lymphatic system disorders
Hypocalcemia
|
25.0%
1/4 • Number of events 1
|
0.00%
0/2
|
|
Blood and lymphatic system disorders
Hypokalemia
|
25.0%
1/4 • Number of events 1
|
0.00%
0/2
|
|
Blood and lymphatic system disorders
Hypophosphatemia
|
25.0%
1/4 • Number of events 1
|
0.00%
0/2
|
|
Infections and infestations
Infection
|
25.0%
1/4 • Number of events 1
|
0.00%
0/2
|
|
General disorders
Mood alteration
|
25.0%
1/4 • Number of events 1
|
0.00%
0/2
|
|
General disorders
Mucositis
|
0.00%
0/4
|
100.0%
2/2 • Number of events 2
|
|
General disorders
Muscular pain
|
25.0%
1/4 • Number of events 1
|
0.00%
0/2
|
|
General disorders
Nausea
|
25.0%
1/4 • Number of events 1
|
0.00%
0/2
|
|
General disorders
Pain at injection site
|
0.00%
0/4
|
50.0%
1/2 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/4
|
100.0%
2/2 • Number of events 3
|
|
General disorders
Shoulder pain
|
0.00%
0/4
|
50.0%
1/2 • Number of events 1
|
|
General disorders
Side pain
|
25.0%
1/4 • Number of events 1
|
0.00%
0/2
|
|
Cardiac disorders
Sinus bradycardia
|
25.0%
1/4 • Number of events 1
|
0.00%
0/2
|
|
General disorders
Sweating
|
0.00%
0/4
|
100.0%
2/2 • Number of events 2
|
|
General disorders
Tremors
|
25.0%
1/4 • Number of events 1
|
0.00%
0/2
|
|
Renal and urinary disorders
Urinary frequency
|
0.00%
0/4
|
50.0%
1/2 • Number of events 1
|
|
General disorders
Urinary incontinence
|
25.0%
1/4 • Number of events 1
|
0.00%
0/2
|
|
Renal and urinary disorders
Urinary retention
|
25.0%
1/4 • Number of events 1
|
0.00%
0/2
|
|
General disorders
Vomiting
|
25.0%
1/4 • Number of events 1
|
50.0%
1/2 • Number of events 1
|
|
General disorders
Weakness
|
25.0%
1/4 • Number of events 1
|
0.00%
0/2
|
|
General disorders
Weight loss
|
25.0%
1/4 • Number of events 1
|
100.0%
2/2 • Number of events 2
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place