Trial Outcomes & Findings for Bicalutamide With or Without Everolimus in Treating Patients With Recurrent or Metastatic Prostate Cancer (NCT NCT00814788)

Last Updated: 2018-01-10

Results Overview

The PSA response rate was defined as a 30% reduction in the PSA level from baseline. PSA Working Group consensus criteria combined with radiographic studies were used to determine the proportion of patients with PSA decline.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

24 participants

Primary outcome timeframe

Up to 2 years

Results posted on

2018-01-10

Participant Flow

Participant milestones

Participant milestones
Measure	Bicalutamide + Everolimus Patients receive oral bicalutamide and oral everolimus once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Bicalutamide 50 mg oral daily Everolimus: RAD001 10 mg oral capsule daily - continuously.
Overall Study STARTED	24
Overall Study COMPLETED	24
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Bicalutamide With or Without Everolimus in Treating Patients With Recurrent or Metastatic Prostate Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Bicalutamide + Everolimus n=24 Participants Patients receive oral bicalutamide and oral everolimus once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. bicalutamide: Bicalutamide 50 mg oral daily Everolimus: RAD001 10 mg oral capsule daily - continuously.
Age, Continuous	71.1 years n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	24 Participants n=5 Participants
Region of Enrollment United States	24 participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 2 years

Outcome measures

Outcome measures
Measure	Bicalutamide + Everolimus n=24 Participants Patients receive oral bicalutamide and oral everolimus once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. bicalutamide: Bicalutamide 50 mg oral daily Everolimus: RAD001 10 mg oral capsule daily - continuously.
PSA Response Rate	18 Participants

SECONDARY outcome

Timeframe: Up to 2 years

Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions

Outcome measures

Outcome measures
Measure	Bicalutamide + Everolimus n=24 Participants Patients receive oral bicalutamide and oral everolimus once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. bicalutamide: Bicalutamide 50 mg oral daily Everolimus: RAD001 10 mg oral capsule daily - continuously.
Progression-free Survival	9.4 months Interval 4.0 to 25.0

SECONDARY outcome

Timeframe: Up to 3 years

Overall survival was estimated using the Kaplan-Meier method.

Outcome measures

Outcome measures
Measure	Bicalutamide + Everolimus n=24 Participants Patients receive oral bicalutamide and oral everolimus once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. bicalutamide: Bicalutamide 50 mg oral daily Everolimus: RAD001 10 mg oral capsule daily - continuously.
Overall Survival	28 months Interval 14.1 to 42.7

Adverse Events

Bicalutamide + Everolimus

Serious events: 1 serious events

Other events: 17 other events

Deaths: 2 deaths

Serious adverse events

Serious adverse events
Measure	Bicalutamide + Everolimus n=24 participants at risk Patients receive oral bicalutamide and oral everolimus once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Bicalutamide 50 mg oral daily Everolimus: RAD001 10 mg oral capsule daily - continuously.
General disorders Sepsis	4.2% 1/24 • Number of events 1 • Up to 2 years

Other adverse events

Other adverse events
Measure	Bicalutamide + Everolimus n=24 participants at risk Patients receive oral bicalutamide and oral everolimus once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Bicalutamide 50 mg oral daily Everolimus: RAD001 10 mg oral capsule daily - continuously.
Blood and lymphatic system disorders Anemia	58.3% 14/24 • Number of events 14 • Up to 2 years
Skin and subcutaneous tissue disorders Acne	4.2% 1/24 • Number of events 1 • Up to 2 years
Hepatobiliary disorders ALT increase	16.7% 4/24 • Number of events 4 • Up to 2 years
Hepatobiliary disorders ALK phosphastase increased	25.0% 6/24 • Number of events 6 • Up to 2 years
General disorders Anal mucositis	4.2% 1/24 • Number of events 1 • Up to 2 years
Psychiatric disorders Anorexia	20.8% 5/24 • Number of events 5 • Up to 2 years
Gastrointestinal disorders Abdominal pain	12.5% 3/24 • Number of events 3 • Up to 2 years
Hepatobiliary disorders AST increased	33.3% 8/24 • Number of events 8 • Up to 2 years
Gastrointestinal disorders Constipation	12.5% 3/24 • Number of events 3 • Up to 2 years
General disorders Constitutional Symptoms	4.2% 1/24 • Number of events 1 • Up to 2 years
Gastrointestinal disorders Diarrhea	16.7% 4/24 • Number of events 4 • Up to 2 years
General disorders Dry mouth	4.2% 1/24 • Number of events 1 • Up to 2 years
Skin and subcutaneous tissue disorders Dry skin	8.3% 2/24 • Number of events 2 • Up to 2 years
Respiratory, thoracic and mediastinal disorders Dyspnea	12.5% 3/24 • Number of events 3 • Up to 2 years
Vascular disorders Deep Vein Thrombosis	4.2% 1/24 • Number of events 1 • Up to 2 years
Blood and lymphatic system disorders Edema	25.0% 6/24 • Number of events 6 • Up to 2 years
General disorders Fatigue	66.7% 16/24 • Number of events 16 • Up to 2 years
Skin and subcutaneous tissue disorders Hand Foot Syndrome	4.2% 1/24 • Number of events 1 • Up to 2 years
Cardiac disorders Hypercholesterolemia	62.5% 15/24 • Number of events 15 • Up to 2 years
Renal and urinary disorders Hyperglycemia	50.0% 12/24 • Number of events 12 • Up to 2 years
Cardiac disorders Hypertriglyceridemia	54.2% 13/24 • Number of events 13 • Up to 2 years
Blood and lymphatic system disorders Leukopenia	70.8% 17/24 • Number of events 17 • Up to 2 years
Blood and lymphatic system disorders Lymphopenia	66.7% 16/24 • Number of events 16 • Up to 2 years
Skin and subcutaneous tissue disorders Oral mucositis	58.3% 14/24 • Number of events 14 • Up to 2 years
Blood and lymphatic system disorders Neutropenia	37.5% 9/24 • Number of events 9 • Up to 2 years
Gastrointestinal disorders Nausea	4.2% 1/24 • Number of events 1 • Up to 2 years
Respiratory, thoracic and mediastinal disorders Pneumonitis	25.0% 6/24 • Number of events 6 • Up to 2 years
Respiratory, thoracic and mediastinal disorders Pneumonia	4.2% 1/24 • Number of events 1 • Up to 2 years
Blood and lymphatic system disorders Proteinuria	12.5% 3/24 • Number of events 3 • Up to 2 years
Skin and subcutaneous tissue disorders Pruritus	8.3% 2/24 • Number of events 2 • Up to 2 years
Skin and subcutaneous tissue disorders Rash	20.8% 5/24 • Number of events 5 • Up to 2 years
Musculoskeletal and connective tissue disorders Right hip pain	4.2% 1/24 • Number of events 1 • Up to 2 years
Renal and urinary disorders Renal Failure	8.3% 2/24 • Number of events 2 • Up to 2 years
General disorders Taste Alteration	16.7% 4/24 • Number of events 4 • Up to 2 years
Blood and lymphatic system disorders Thrombocytopenia	33.3% 8/24 • Number of events 8 • Up to 2 years
General disorders Weight Loss	8.3% 2/24 • Number of events 2 • Up to 2 years

Additional Information

Analyst

University of California Davis

Phone: 916 734 0294

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place