Trial Outcomes & Findings for Temsirolimus to Reverse Androgen Insensitivity for Castration-resistant Prostate Cancer (NCT NCT01020305)
NCT ID: NCT01020305
Last Updated: 2014-10-13
Results Overview
Proportion of subjects with \> 50% drop in serum PSA as compared to baseline, assessed at 16 weeks
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
5 participants
Primary outcome timeframe
12 weeks treatment, with primary outcome assessed at 16 weeks
Results posted on
2014-10-13
Participant Flow
Participant milestones
| Measure |
Temsirolimus + Bicalutamide
Temsirolimus 25 mg administered intravenously (IV) once weekly for 12 weeks
Casodex (bicalutamide) administered 50 mg/day orally (PO)
Temsirolimus: Temsirolimus is an inhibitor of the mammalian target of rapamycin (MTOR, aka HGNC:3942)
IUPAC name: (1R,2R,4S)-4-{(2R)-2-\[(3S,6R,7E,9R,10R,12R,14S,15E,17E,19E,21S,23S,26R,27R,34aS)-9,27-dihydroxy-10,21-dimethoxy-6,8,12,14,20,26-hexamethyl-1,5,11,28,29-pentaoxo-1,4,5,6,9,10,11,12,13,14,21,22,23,24,25,26,27,28,29,31,32,33,34,34a-tetracosahydro-3H-23,27-epoxypyrido\[2,1-c\]\[1,4\]oxazacyclohentriacontin-3-yl\]propyl}-2-methoxycyclohexyl 3-hydroxy-2-(hydroxymethyl)-2-methylpropanoate
Casodex (bicalutamide): Casodex (bicalutamide) 50 mg/day PO
|
|---|---|
|
Overall Study
STARTED
|
5
|
|
Overall Study
COMPLETED
|
3
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
Temsirolimus + Bicalutamide
Temsirolimus 25 mg administered intravenously (IV) once weekly for 12 weeks
Casodex (bicalutamide) administered 50 mg/day orally (PO)
Temsirolimus: Temsirolimus is an inhibitor of the mammalian target of rapamycin (MTOR, aka HGNC:3942)
IUPAC name: (1R,2R,4S)-4-{(2R)-2-\[(3S,6R,7E,9R,10R,12R,14S,15E,17E,19E,21S,23S,26R,27R,34aS)-9,27-dihydroxy-10,21-dimethoxy-6,8,12,14,20,26-hexamethyl-1,5,11,28,29-pentaoxo-1,4,5,6,9,10,11,12,13,14,21,22,23,24,25,26,27,28,29,31,32,33,34,34a-tetracosahydro-3H-23,27-epoxypyrido\[2,1-c\]\[1,4\]oxazacyclohentriacontin-3-yl\]propyl}-2-methoxycyclohexyl 3-hydroxy-2-(hydroxymethyl)-2-methylpropanoate
Casodex (bicalutamide): Casodex (bicalutamide) 50 mg/day PO
|
|---|---|
|
Overall Study
Adverse Event
|
2
|
Baseline Characteristics
Temsirolimus to Reverse Androgen Insensitivity for Castration-resistant Prostate Cancer
Baseline characteristics by cohort
| Measure |
Temsirolimus + Bicalutamide
n=5 Participants
Temsirolimus 25 mg administered intravenously (IV) once weekly for 12 weeks
Casodex (bicalutamide) administered 50 mg/day orally (PO)
Temsirolimus: Temsirolimus is an inhibitor of the mammalian target of rapamycin (MTOR, aka HGNC:3942)
IUPAC name: (1R,2R,4S)-4-{(2R)-2-\[(3S,6R,7E,9R,10R,12R,14S,15E,17E,19E,21S,23S,26R,27R,34aS)-9,27-dihydroxy-10,21-dimethoxy-6,8,12,14,20,26-hexamethyl-1,5,11,28,29-pentaoxo-1,4,5,6,9,10,11,12,13,14,21,22,23,24,25,26,27,28,29,31,32,33,34,34a-tetracosahydro-3H-23,27-epoxypyrido\[2,1-c\]\[1,4\]oxazacyclohentriacontin-3-yl\]propyl}-2-methoxycyclohexyl 3-hydroxy-2-(hydroxymethyl)-2-methylpropanoate
Casodex (bicalutamide): Casodex (bicalutamide) 50 mg/day PO
|
|---|---|
|
Age, Continuous
|
73 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 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
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
4 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
|
PRIMARY outcome
Timeframe: 12 weeks treatment, with primary outcome assessed at 16 weeksProportion of subjects with \> 50% drop in serum PSA as compared to baseline, assessed at 16 weeks
Outcome measures
| Measure |
Temsirolimus + Bicalutamide
n=3 Participants
Temsirolimus 25 mg administered intravenously (IV) once weekly for 12 weeks
Casodex (bicalutamide) administered 50 mg/day orally (PO)
Temsirolimus: Temsirolimus is an inhibitor of the mammalian target of rapamycin (MTOR, aka HGNC:3942)
IUPAC name: (1R,2R,4S)-4-{(2R)-2-\[(3S,6R,7E,9R,10R,12R,14S,15E,17E,19E,21S,23S,26R,27R,34aS)-9,27-dihydroxy-10,21-dimethoxy-6,8,12,14,20,26-hexamethyl-1,5,11,28,29-pentaoxo-1,4,5,6,9,10,11,12,13,14,21,22,23,24,25,26,27,28,29,31,32,33,34,34a-tetracosahydro-3H-23,27-epoxypyrido\[2,1-c\]\[1,4\]oxazacyclohentriacontin-3-yl\]propyl}-2-methoxycyclohexyl 3-hydroxy-2-(hydroxymethyl)-2-methylpropanoate
Casodex (bicalutamide): Casodex (bicalutamide) 50 mg/day PO
|
|---|---|
|
Reduction in Serum PSA
|
0 participants
|
Adverse Events
Temsirolimus + Bicalutamide
Serious events: 1 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Temsirolimus + Bicalutamide
n=5 participants at risk
Temsirolimus 25 mg administered intravenously (IV) once weekly for 12 weeks
Casodex (bicalutamide) administered 50 mg/day orally (PO)
Temsirolimus: Temsirolimus is an inhibitor of the mammalian target of rapamycin (MTOR, aka HGNC:3942)
IUPAC name: (1R,2R,4S)-4-{(2R)-2-\[(3S,6R,7E,9R,10R,12R,14S,15E,17E,19E,21S,23S,26R,27R,34aS)-9,27-dihydroxy-10,21-dimethoxy-6,8,12,14,20,26-hexamethyl-1,5,11,28,29-pentaoxo-1,4,5,6,9,10,11,12,13,14,21,22,23,24,25,26,27,28,29,31,32,33,34,34a-tetracosahydro-3H-23,27-epoxypyrido\[2,1-c\]\[1,4\]oxazacyclohentriacontin-3-yl\]propyl}-2-methoxycyclohexyl 3-hydroxy-2-(hydroxymethyl)-2-methylpropanoate
Casodex (bicalutamide): Casodex (bicalutamide) 50 mg/day PO
|
|---|---|
|
Gastrointestinal disorders
Colitis
|
20.0%
1/5 • Number of events 1
|
Other adverse events
| Measure |
Temsirolimus + Bicalutamide
n=5 participants at risk
Temsirolimus 25 mg administered intravenously (IV) once weekly for 12 weeks
Casodex (bicalutamide) administered 50 mg/day orally (PO)
Temsirolimus: Temsirolimus is an inhibitor of the mammalian target of rapamycin (MTOR, aka HGNC:3942)
IUPAC name: (1R,2R,4S)-4-{(2R)-2-\[(3S,6R,7E,9R,10R,12R,14S,15E,17E,19E,21S,23S,26R,27R,34aS)-9,27-dihydroxy-10,21-dimethoxy-6,8,12,14,20,26-hexamethyl-1,5,11,28,29-pentaoxo-1,4,5,6,9,10,11,12,13,14,21,22,23,24,25,26,27,28,29,31,32,33,34,34a-tetracosahydro-3H-23,27-epoxypyrido\[2,1-c\]\[1,4\]oxazacyclohentriacontin-3-yl\]propyl}-2-methoxycyclohexyl 3-hydroxy-2-(hydroxymethyl)-2-methylpropanoate
Casodex (bicalutamide): Casodex (bicalutamide) 50 mg/day PO
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
80.0%
4/5 • Number of events 4
|
|
Cardiac disorders
Chest pain - cardiac
|
20.0%
1/5 • Number of events 1
|
|
Cardiac disorders
Other-Tachycardia
|
20.0%
1/5 • Number of events 1
|
|
Cardiac disorders
Palpitations
|
20.0%
1/5 • Number of events 1
|
|
Gastrointestinal disorders
Constipation
|
20.0%
1/5 • Number of events 1
|
|
General disorders
Diarrhea
|
20.0%
1/5 • Number of events 1
|
|
Gastrointestinal disorders
Nausea
|
20.0%
1/5 • Number of events 1
|
|
General disorders
Edema, trunk
|
20.0%
1/5 • Number of events 1
|
|
General disorders
Fatigue
|
40.0%
2/5 • Number of events 2
|
|
General disorders
Other-fall
|
20.0%
1/5 • Number of events 1
|
|
Investigations
Alkaline phosphatase increased
|
20.0%
1/5 • Number of events 1
|
|
Investigations
Cholesterol high
|
60.0%
3/5 • Number of events 3
|
|
Investigations
Increase ALT
|
40.0%
2/5 • Number of events 2
|
|
Investigations
Increase AST
|
40.0%
2/5 • Number of events 2
|
|
Investigations
Increase creatinine
|
40.0%
2/5 • Number of events 2
|
|
Investigations
Increase in HDL
|
40.0%
2/5 • Number of events 2
|
|
Investigations
Increase LDL
|
60.0%
3/5 • Number of events 3
|
|
Investigations
Platelet count decreased
|
40.0%
2/5 • Number of events 2
|
|
Investigations
Weight loss
|
60.0%
3/5 • Number of events 3
|
|
Metabolism and nutrition disorders
Anorexia
|
60.0%
3/5 • Number of events 3
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
20.0%
1/5 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypertriglyceridemia
|
40.0%
2/5 • Number of events 2
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
40.0%
2/5 • Number of events 2
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
20.0%
1/5 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypokalemia
|
60.0%
3/5 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
Other-Bilateral Knee pain
|
20.0%
1/5 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
20.0%
1/5 • Number of events 1
|
|
Nervous system disorders
Dysgeusia
|
20.0%
1/5 • Number of events 1
|
|
Psychiatric disorders
Anxiety
|
20.0%
1/5 • Number of events 1
|
|
Renal and urinary disorders
Hematuria
|
20.0%
1/5 • Number of events 1
|
|
Renal and urinary disorders
Urinary incontinence
|
20.0%
1/5 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
40.0%
2/5 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
20.0%
1/5 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Other-Sinus congestion
|
20.0%
1/5 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
20.0%
1/5 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
40.0%
2/5 • Number of events 2
|
Additional Information
Associate Professor of Medicine (Oncology)
Stanford University Medical Center
Phone: 650-725-2078
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place