Trial Outcomes & Findings for Study of SU11248 in Men With Advanced Prostate Cancer (NCT NCT00299741)

Last Updated: 2012-12-19

Results Overview

Prostate specific antigen (PSA) responses, defined as the number of men who exhibit PSA decline of at least 50% that is confirmed by a second PSA value 4 or more weeks later (PSA Working Group I Criteria)

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

36 participants

Primary outcome timeframe

were followed until disease progression, an average of 12 weeks

Results posted on

2012-12-19

Participant Flow

Patients identified from routine care in oncology clinic

Participant milestones

Participant milestones
Measure	Metastatic Prostate Cancer Treated With Sunitinib Sunitinib administered orally at a dosage of 37.5 mg once daily
Overall Study STARTED	36
Overall Study COMPLETED	36
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Study of SU11248 in Men With Advanced Prostate Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Metastatic Prostate Cancer Treated With Sunitinib n=36 Participants Sunitinib
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	16 Participants n=5 Participants
Age, Categorical >=65 years	20 Participants n=5 Participants
Age Continuous	68 years STANDARD_DEVIATION 10 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	36 Participants n=5 Participants
Region of Enrollment United States	36 participants n=5 Participants

PRIMARY outcome

Timeframe: were followed until disease progression, an average of 12 weeks

Population: All participants analyzed

Outcome measures

Outcome measures
Measure	Metastatic Prostate Cancer Treated With Sunitinib n=36 Participants Sunitinib
The Number of Men With Advanced Prostate Cancer Treated With Sunitinib Who Have a Prostate Specific Antigen (PSA) Response	2 participants

SECONDARY outcome

Timeframe: Participants were followed until the time of disease progression, an average of 12 weeks

The response rate is defined by Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.0) for target lesions as assessed by radiographic evaluation. Complete response(CR): disappearance of all target lesions; Partial response(PR): \>=30% decrease in the sum of the longest diameter of target lesions; Overall response = CR + PR.

Outcome measures

Outcome measures
Measure	Metastatic Prostate Cancer Treated With Sunitinib n=36 Participants Sunitinib
Objective Responses, Defined as the Number of Participants With Complete or Partial Response	1 participants

Adverse Events

Metastatic Prostate Cancer Treated With Sunitinib

Serious events: 25 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Metastatic Prostate Cancer Treated With Sunitinib n=36 participants at risk Sunitinib
Blood and lymphatic system disorders Hemoglobin	8.3% 3/36 • Number of events 3 • Throughout treatment period
Blood and lymphatic system disorders Leukocytes	16.7% 6/36 • Number of events 6 • Throughout treatment period
Blood and lymphatic system disorders Neutrophils	13.9% 5/36 • Number of events 5 • Throughout treatment period
Blood and lymphatic system disorders Platelets	11.1% 4/36 • Number of events 4 • Throughout treatment period
Hepatobiliary disorders ALT/AST elevation	2.8% 1/36 • Number of events 1 • Throughout treatment period
Renal and urinary disorders Creatinine	2.8% 1/36 • Number of events 1 • Throughout treatment period
Renal and urinary disorders Hyponatremia	2.8% 1/36 • Number of events 1 • Throughout treatment period
Cardiac disorders Hypertension	13.9% 5/36 • Number of events 5 • Throughout treatment period
Cardiac disorders Left Ventricular Dysfunction	2.8% 1/36 • Number of events 1 • Throughout treatment period
General disorders Fatigue	8.3% 3/36 • Number of events 3 • Throughout treatment period
Gastrointestinal disorders Diarrhea	11.1% 4/36 • Number of events 4 • Throughout treatment period
Gastrointestinal disorders Lower GI hemorrhage	2.8% 1/36 • Number of events 1 • Throughout treatment period
Nervous system disorders Neuropathy - sensory	2.8% 1/36 • Number of events 1 • Throughout treatment period
Nervous system disorders Seizure	2.8% 1/36 • Number of events 1 • Throughout treatment period
Nervous system disorders Headache	2.8% 1/36 • Number of events 1 • Throughout treatment period
Vascular disorders Thrombosis/Embolism	2.8% 1/36 • Number of events 1 • Throughout treatment period

Other adverse events

Adverse event data not reported

Additional Information

Dr. Dror Michaelson

Massachusetts General Hospital

Phone: 617-726-1594

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place