Trial Outcomes & Findings for Safety Study of Sorafenib With Androgen Deprivation and Radiotherapy to Treat Prostate Cancer (NCT NCT00924807)

Last Updated: 2018-12-11

Results Overview

Data of zero ("0") participants were analyzed due to lack of funding and prematurely terminating the study by sponsor. All subjects are following up in the clinic off the study.

Recruitment status

TERMINATED

Study phase

PHASE1/PHASE2

Target enrollment

4 participants

Primary outcome timeframe

Day 29 and every 2 weeks

Results posted on

2018-12-11

Participant Flow

Participant milestones

Participant milestones
Measure	Androgen Depr, Radiotherapy, Sorafenib Everyone will receive Leuprolide acetate, Bicalutamide,Sorafenib and radiotherapy. Leuprolide acetate, Bicalutamide, Sorafenib: Leuprolide acetate - depot, Bicalutamide 50 mg, Sorafenib 400mg
Overall Study STARTED	4
Overall Study COMPLETED	4
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Safety Study of Sorafenib With Androgen Deprivation and Radiotherapy to Treat Prostate Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Androgen Depr, Radiotherapy, Sorafenib n=4 Participants Everyone will receive Leuprolide acetate, Bicalutamide,Sorafenib and radiotherapy. Leuprolide acetate, Bicalutamide, Sorafenib: Leuprolide acetate - depot, Bicalutamide 50 mg, Sorafenib 400mg
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	2 Participants n=5 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants
Age, Continuous	66.25 years n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants
Region of Enrollment United States	4 participants n=5 Participants
Gleason 7 histology, or PSA 10-20	4 participants n=5 Participants

PRIMARY outcome

Timeframe: Day 29 and every 2 weeks

Population: Data of zero ("0") participants were analyzed due to lack of funding and prematurely terminating the study by sponsor. All subjects are following up in the clinic off the study.

Data of zero ("0") participants were analyzed due to lack of funding and prematurely terminating the study by sponsor. All subjects are following up in the clinic off the study.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: after 9 months

Population: data not collected

Data of zero ("0") participants were analyzed due to lack of funding and prematurely terminating the study by sponsor. All subjects are following up in the clinic off the study.

Outcome measures

Outcome data not reported

Adverse Events

Androgen Depr, Radiotherapy, Sorafenib

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Androgen Depr, Radiotherapy, Sorafenib n=4 participants at risk Everyone will receive Leuprolide acetate, Bicalutamide,Sorafenib and radiotherapy. Leuprolide acetate, Bicalutamide, Sorafenib: Leuprolide acetate - depot, Bicalutamide 50 mg, Sorafenib 400mg
Cardiac disorders Hypertension	75.0% 3/4 • Number of events 3 • 18 months Adverse Events were assessed by regular investigator assessment, regular laboratory testing
Renal and urinary disorders Urinary frequency/urgency	100.0% 4/4 • Number of events 4 • 18 months Adverse Events were assessed by regular investigator assessment, regular laboratory testing
Renal and urinary disorders Urinary retention	25.0% 1/4 • Number of events 1 • 18 months Adverse Events were assessed by regular investigator assessment, regular laboratory testing
Renal and urinary disorders dysuria	75.0% 3/4 • Number of events 3 • 18 months Adverse Events were assessed by regular investigator assessment, regular laboratory testing
Skin and subcutaneous tissue disorders Hand-and-foot syndrome	50.0% 2/4 • Number of events 2 • 18 months Adverse Events were assessed by regular investigator assessment, regular laboratory testing
Endocrine disorders Hot flashes	25.0% 1/4 • Number of events 1 • 18 months Adverse Events were assessed by regular investigator assessment, regular laboratory testing
Gastrointestinal disorders Diarrhea	25.0% 1/4 • Number of events 1 • 18 months Adverse Events were assessed by regular investigator assessment, regular laboratory testing
Gastrointestinal disorders Flatulence	50.0% 2/4 • Number of events 2 • 18 months Adverse Events were assessed by regular investigator assessment, regular laboratory testing
Gastrointestinal disorders Proctitis	25.0% 1/4 • Number of events 1 • 18 months Adverse Events were assessed by regular investigator assessment, regular laboratory testing
Eye disorders Ocular-Amaurosis fugax	25.0% 1/4 • Number of events 1 • 18 months Adverse Events were assessed by regular investigator assessment, regular laboratory testing

Additional Information

Seth Cohen, MD

St. Luke's Roosevelt Hospital Center

Phone: 212-523-7289

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place