Trial Outcomes & Findings for Bicalutamide and RO4929097 in Treating Patients With Previously Treated Prostate Cancer (NCT NCT01200810)
NCT ID: NCT01200810
Last Updated: 2017-12-02
Results Overview
Time to PSA progression will be compared in the two groups using a log-rank test for a maximum of 54 weeks.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
10 participants
Primary outcome timeframe
Up to 12 months
Results posted on
2017-12-02
Participant Flow
A total of 19 patients were enrolled from a comprehensive cancer center in central New Jersey from August 2010 through November 2011.
During the induction phase, if subjects do not have a decline in PSA ≥ 50%, they are taken off study. Subjects who have a PSA decline ≥ 50% are randomized to Arm I or Arm II.
Participant milestones
| Measure |
Arm I - Placebo
Patients receive oral placebo once daily on days 1-3, 8-10, and 15-17. Treatment repeats every 21 days for 18 courses in the absence of PSA progression.
COMBINATION PHASE: All patients then receive oral bicalutamide once daily on days 1-21 and oral RO4929097 once daily on days 1-3, 8-10, and 15-17. Courses repeat every 21 days for 12 months in the absence of disease progression or unacceptable toxicity.
placebo: Given orally
gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given orally
bicalutamide: Given orally
|
Arm II - RO4929097
Patients receive oral RO4929097 once daily on days 1-3, 8-10, and 15-17. Treatment repeats every 21 days for 18 courses in the absence of PSA progression.
COMBINATION PHASE: All patients then receive oral bicalutamide once daily on days 1-21 and oral RO4929097 once daily on days 1-3, 8-10, and 15-17. Courses repeat every 21 days for 12 months in the absence of disease progression or unacceptable toxicity.
gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given orally
bicalutamide: Given orally
|
|---|---|---|
|
Overall Study
STARTED
|
5
|
5
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
5
|
5
|
Reasons for withdrawal
| Measure |
Arm I - Placebo
Patients receive oral placebo once daily on days 1-3, 8-10, and 15-17. Treatment repeats every 21 days for 18 courses in the absence of PSA progression.
COMBINATION PHASE: All patients then receive oral bicalutamide once daily on days 1-21 and oral RO4929097 once daily on days 1-3, 8-10, and 15-17. Courses repeat every 21 days for 12 months in the absence of disease progression or unacceptable toxicity.
placebo: Given orally
gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given orally
bicalutamide: Given orally
|
Arm II - RO4929097
Patients receive oral RO4929097 once daily on days 1-3, 8-10, and 15-17. Treatment repeats every 21 days for 18 courses in the absence of PSA progression.
COMBINATION PHASE: All patients then receive oral bicalutamide once daily on days 1-21 and oral RO4929097 once daily on days 1-3, 8-10, and 15-17. Courses repeat every 21 days for 12 months in the absence of disease progression or unacceptable toxicity.
gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given orally
bicalutamide: Given orally
|
|---|---|---|
|
Overall Study
Physician Decision
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
2
|
|
Overall Study
Sponsor stopped making study drug
|
3
|
3
|
Baseline Characteristics
Bicalutamide and RO4929097 in Treating Patients With Previously Treated Prostate Cancer
Baseline characteristics by cohort
| Measure |
Arm I
n=5 Participants
Patients receive oral placebo once daily on days 1-3, 8-10, and 15-17. Treatment repeats every 21 days for 18 courses in the absence of PSA progression.
COMBINATION PHASE: All patients then receive oral bicalutamide once daily on days 1-21 and oral RO4929097 once daily on days 1-3, 8-10, and 15-17. Courses repeat every 21 days for 12 months in the absence of disease progression or unacceptable toxicity.
placebo: Given orally
gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given orally
bicalutamide: Given orally
|
Arm II
n=5 Participants
Patients receive oral RO4929097 once daily on days 1-3, 8-10, and 15-17. Treatment repeats every 21 days for 18 courses in the absence of PSA progression.
COMBINATION PHASE: All patients then receive oral bicalutamide once daily on days 1-21 and oral RO4929097 once daily on days 1-3, 8-10, and 15-17. Courses repeat every 21 days for 12 months in the absence of disease progression or unacceptable toxicity.
gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given orally
bicalutamide: Given orally
|
Total
n=10 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
62 years
STANDARD_DEVIATION 6.28 • n=5 Participants
|
67.6 years
STANDARD_DEVIATION 7.5 • n=7 Participants
|
64.8 years
STANDARD_DEVIATION 7.16 • n=5 Participants
|
|
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
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
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
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
10 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
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 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
|
|
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
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
10 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
|
|
Region of Enrollment
United States
|
5 participants
n=5 Participants
|
5 participants
n=7 Participants
|
10 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 12 monthsPopulation: Data were not collected as the protocol was terminated early due to lack of study drug. Only three patients progressed during randomization phase.
Time to PSA progression will be compared in the two groups using a log-rank test for a maximum of 54 weeks.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 12 monthsPopulation: Data were not collected as study was terminated early due to lack of study drug. Only three patients started combination phase and were then removed from study due to lack of study drug.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 12 monthsPopulation: Data were not collected as study was terminated early due to lack of study drug. Only three patients started combination phase and were then removed from study due to lack of study drug.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 12 monthsPopulation: Data were not collected as study was terminated early due to lack of study drug.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 12 monthsPopulation: Data were not collected as study was terminated early due to lack of study drug.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 12 monthsPopulation: Data were not collected as study was terminated early due to lack of study drug. No subjects entered the observation phase.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 12 monthsPopulation: Data were not collected as study was terminated early due to lack of study drug. No subjects entered the observation phase.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 12 monthsNumber of participants randomized to RO4929097 arm who experienced serious adverse events .
Outcome measures
| Measure |
Arm I
n=5 Participants
Patients receive oral placebo once daily on days 1-3, 8-10, and 15-17. Treatment repeats every 21 days for 18 courses in the absence of PSA progression.
COMBINATION PHASE: All patients then receive oral bicalutamide once daily on days 1-21 and oral RO4929097 once daily on days 1-3, 8-10, and 15-17. Courses repeat every 21 days for 12 months in the absence of disease progression or unacceptable toxicity.
placebo: Given orally
gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given orally
bicalutamide: Given orally
|
Arm II
n=5 Participants
Patients receive oral RO4929097 once daily on days 1-3, 8-10, and 15-17. Treatment repeats every 21 days for 18 courses in the absence of PSA progression.
COMBINATION PHASE: All patients then receive oral bicalutamide once daily on days 1-21 and oral RO4929097 once daily on days 1-3, 8-10, and 15-17. Courses repeat every 21 days for 12 months in the absence of disease progression or unacceptable toxicity.
gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given orally
bicalutamide: Given orally
|
|---|---|---|
|
Safety and Tolerability Assessed Using NCI CTCAE Version 4.0
|
0 participants
|
0 participants
|
Adverse Events
Arm I - Placebo
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Arm II - RO4929097
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Arm I - Placebo
n=5 participants at risk
Patients receive oral placebo once daily on days 1-3, 8-10, and 15-17. Treatment repeats every 21 days for 18 courses in the absence of PSA progression.
COMBINATION PHASE: All patients then receive oral bicalutamide once daily on days 1-21 and oral RO4929097 once daily on days 1-3, 8-10, and 15-17. Courses repeat every 21 days for 12 months in the absence of disease progression or unacceptable toxicity.
placebo: Given orally
gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given orally
bicalutamide: Given orally
|
Arm II - RO4929097
n=5 participants at risk
Patients receive oral RO4929097 once daily on days 1-3, 8-10, and 15-17. Treatment repeats every 21 days for 18 courses in the absence of PSA progression.
COMBINATION PHASE: All patients then receive oral bicalutamide once daily on days 1-21 and oral RO4929097 once daily on days 1-3, 8-10, and 15-17. Courses repeat every 21 days for 12 months in the absence of disease progression or unacceptable toxicity.
gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given orally
bicalutamide: Given orally
|
|---|---|---|
|
Metabolism and nutrition disorders
Hyphosphatemia
|
0.00%
0/5 • 12 months
|
20.0%
1/5 • Number of events 2 • 12 months
|
|
Nervous system disorders
Headache
|
0.00%
0/5 • 12 months
|
20.0%
1/5 • Number of events 1 • 12 months
|
|
Nervous system disorders
lightheadedness
|
0.00%
0/5 • 12 months
|
20.0%
1/5 • Number of events 1 • 12 months
|
|
Vascular disorders
hot flashes
|
0.00%
0/5 • 12 months
|
40.0%
2/5 • Number of events 3 • 12 months
|
|
Gastrointestinal disorders
constipation with blood
|
0.00%
0/5 • 12 months
|
20.0%
1/5 • Number of events 1 • 12 months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
20.0%
1/5 • Number of events 1 • 12 months
|
20.0%
1/5 • Number of events 1 • 12 months
|
|
Cardiac disorders
chest pain
|
0.00%
0/5 • 12 months
|
20.0%
1/5 • Number of events 2 • 12 months
|
|
Reproductive system and breast disorders
Breast tenderness
|
20.0%
1/5 • Number of events 1 • 12 months
|
60.0%
3/5 • Number of events 5 • 12 months
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/5 • 12 months
|
20.0%
1/5 • Number of events 1 • 12 months
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/5 • 12 months
|
20.0%
1/5 • Number of events 1 • 12 months
|
|
Musculoskeletal and connective tissue disorders
Arthritic pain
|
0.00%
0/5 • 12 months
|
20.0%
1/5 • Number of events 1 • 12 months
|
|
Infections and infestations
Bilateral eye infection
|
0.00%
0/5 • 12 months
|
20.0%
1/5 • Number of events 1 • 12 months
|
|
Infections and infestations
Contact dermatitis
|
0.00%
0/5 • 12 months
|
20.0%
1/5 • Number of events 1 • 12 months
|
|
Investigations
Decreased lymphocytes
|
0.00%
0/5 • 12 months
|
20.0%
1/5 • Number of events 1 • 12 months
|
|
Gastrointestinal disorders
Diarrhea
|
40.0%
2/5 • Number of events 3 • 12 months
|
20.0%
1/5 • Number of events 1 • 12 months
|
|
Investigations
Elevated Alkaline phosphatase
|
0.00%
0/5 • 12 months
|
20.0%
1/5 • Number of events 1 • 12 months
|
|
Investigations
Elevated ALT
|
0.00%
0/5 • 12 months
|
20.0%
1/5 • Number of events 1 • 12 months
|
|
Skin and subcutaneous tissue disorders
Erythematous right shin lesion
|
20.0%
1/5 • Number of events 1 • 12 months
|
0.00%
0/5 • 12 months
|
|
Infections and infestations
Erythematous rash
|
0.00%
0/5 • 12 months
|
20.0%
1/5 • Number of events 1 • 12 months
|
|
General disorders
Fatigue
|
40.0%
2/5 • Number of events 3 • 12 months
|
40.0%
2/5 • Number of events 3 • 12 months
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/5 • 12 months
|
20.0%
1/5 • Number of events 1 • 12 months
|
|
Reproductive system and breast disorders
Gynecomastia
|
0.00%
0/5 • 12 months
|
20.0%
1/5 • Number of events 1 • 12 months
|
|
Ear and labyrinth disorders
Hearing impairment
|
0.00%
0/5 • 12 months
|
20.0%
1/5 • Number of events 1 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
20.0%
1/5 • Number of events 2 • 12 months
|
0.00%
0/5 • 12 months
|
|
Investigations
hyperbilirubinemia
|
20.0%
1/5 • Number of events 1 • 12 months
|
0.00%
0/5 • 12 months
|
|
Vascular disorders
Hypertension
|
20.0%
1/5 • Number of events 1 • 12 months
|
0.00%
0/5 • 12 months
|
|
Metabolism and nutrition disorders
hypophosphatemia
|
0.00%
0/5 • 12 months
|
20.0%
1/5 • Number of events 2 • 12 months
|
|
Metabolism and nutrition disorders
hyperglycemia
|
20.0%
1/5 • Number of events 1 • 12 months
|
40.0%
2/5 • Number of events 2 • 12 months
|
|
Metabolism and nutrition disorders
Low phosphorous
|
20.0%
1/5 • Number of events 1 • 12 months
|
0.00%
0/5 • 12 months
|
|
Musculoskeletal and connective tissue disorders
Joint pain
|
20.0%
1/5 • Number of events 1 • 12 months
|
0.00%
0/5 • 12 months
|
|
Renal and urinary disorders
Kidney stone
|
0.00%
0/5 • 12 months
|
20.0%
1/5 • Number of events 1 • 12 months
|
|
Investigations
leukopenia
|
20.0%
1/5 • Number of events 1 • 12 months
|
0.00%
0/5 • 12 months
|
|
Investigations
lymphopenia
|
20.0%
1/5 • Number of events 1 • 12 months
|
0.00%
0/5 • 12 months
|
|
Musculoskeletal and connective tissue disorders
Muscle pain
|
20.0%
1/5 • Number of events 1 • 12 months
|
0.00%
0/5 • 12 months
|
|
Gastrointestinal disorders
Nausea
|
20.0%
1/5 • Number of events 2 • 12 months
|
20.0%
1/5 • Number of events 2 • 12 months
|
|
Renal and urinary disorders
Nocturia
|
0.00%
0/5 • 12 months
|
20.0%
1/5 • Number of events 1 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Nose bleed
|
0.00%
0/5 • 12 months
|
20.0%
1/5 • Number of events 1 • 12 months
|
|
Gastrointestinal disorders
Proctitis
|
20.0%
1/5 • Number of events 1 • 12 months
|
0.00%
0/5 • 12 months
|
|
Skin and subcutaneous tissue disorders
Pruritic macular rash
|
20.0%
1/5 • Number of events 1 • 12 months
|
0.00%
0/5 • 12 months
|
|
Infections and infestations
Rhinorrhea
|
0.00%
0/5 • 12 months
|
20.0%
1/5 • Number of events 1 • 12 months
|
|
Musculoskeletal and connective tissue disorders
Right fore arm pain
|
20.0%
1/5 • Number of events 1 • 12 months
|
0.00%
0/5 • 12 months
|
|
Renal and urinary disorders
Urinary frequency
|
20.0%
1/5 • Number of events 1 • 12 months
|
0.00%
0/5 • 12 months
|
|
Renal and urinary disorders
Urinary incontinence
|
20.0%
1/5 • Number of events 1 • 12 months
|
0.00%
0/5 • 12 months
|
|
Gastrointestinal disorders
Vomiting
|
20.0%
1/5 • Number of events 1 • 12 months
|
0.00%
0/5 • 12 months
|
Additional Information
Mark Stein, MD
Rutgers Cancer Institute of New Jersey
Phone: (732) 235-8675
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60