Trial Outcomes & Findings for Pazopanib as Second Line Therapy in Patients With Metastatic Prostate Cancer Refractory to Total Androgen Blockade (NCT NCT00945477)
NCT ID: NCT00945477
Last Updated: 2013-11-18
Results Overview
Response rate defined as 50% decrease in the Prostate Specific Antigen (PSA) level at week 12 compared to baseline
TERMINATED
PHASE2
11 participants
12 weeks
2013-11-18
Participant Flow
Male patients were enrolled from 7/17/2009 through 10/9/2012. All patients were from our practice and screened from our database.
Participant milestones
| Measure |
Advanced Prostate Cancer, Treatment, Pazopanib
Pazopanib
Pazopanib (GW786034) : Pazopanib 800 mg daily x 12 weeks
|
|---|---|
|
Overall Study
STARTED
|
11
|
|
Overall Study
COMPLETED
|
5
|
|
Overall Study
NOT COMPLETED
|
6
|
Reasons for withdrawal
| Measure |
Advanced Prostate Cancer, Treatment, Pazopanib
Pazopanib
Pazopanib (GW786034) : Pazopanib 800 mg daily x 12 weeks
|
|---|---|
|
Overall Study
Adverse Event
|
3
|
|
Overall Study
Lack of Efficacy
|
2
|
|
Overall Study
Withdrawal by Subject
|
1
|
Baseline Characteristics
Pazopanib as Second Line Therapy in Patients With Metastatic Prostate Cancer Refractory to Total Androgen Blockade
Baseline characteristics by cohort
| Measure |
Advanced Prostate Cancer, Treatment, Pazopanib
n=11 Participants
Pazopanib
Pazopanib (GW786034) : Pazopanib 800 mg daily x 12 weeks
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
4 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
7 Participants
n=5 Participants
|
|
Age Continuous
|
68.5 years
STANDARD_DEVIATION 14.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
11 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: Five subjects completed the 12 week treatment requirement.
Response rate defined as 50% decrease in the Prostate Specific Antigen (PSA) level at week 12 compared to baseline
Outcome measures
| Measure |
Pazopanib 800mg Daily by Mouth
n=5 Participants
Response rate at 12 weeks
|
|---|---|
|
Response Rate at 12 Weeks
|
2 participants
|
SECONDARY outcome
Timeframe: 0-12 weeksPopulation: The adverse events for all participants enrolled were evaluated by documentation of Adverse Events (AEs)Grades 1-5 using NCI-CTCAE v 3.0
Safety was evaluated by documentation of Adverse Events (AEs), by assessment of clinical laboratory findings, and by physicial examination, including measurement of vital signs and weight in all eleven subjects.
Outcome measures
| Measure |
Pazopanib 800mg Daily by Mouth
n=11 Participants
Response rate at 12 weeks
|
|---|---|
|
Number Adverse Events, Grades 1-5 Using NCI-CTCAE v 3.0
|
197 Adverse events Grade 1-5
|
Adverse Events
Pazopanib 800mg Daily by Mouth
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Pazopanib 800mg Daily by Mouth
n=11 participants at risk
Response rate at 12 weeks
|
|---|---|
|
Blood and lymphatic system disorders
Hemoglobin
|
90.9%
10/11 • 0-12 weeks
|
|
Blood and lymphatic system disorders
Leukocytes
|
81.8%
9/11 • 0-12 weeks
|
|
Cardiac disorders
Hypertension
|
72.7%
8/11 • 0-12 weeks
|
|
General disorders
Fatigue
|
90.9%
10/11 • 0-12 weeks
|
|
Gastrointestinal disorders
Anorexia
|
63.6%
7/11 • 0-12 weeks
|
|
Gastrointestinal disorders
Diarrhea
|
81.8%
9/11 • 0-12 weeks
|
|
Gastrointestinal disorders
Nausea
|
81.8%
9/11 • 0-12 weeks
|
|
Blood and lymphatic system disorders
Alkaline Phosphatase
|
63.6%
7/11 • 0-12 weeks
|
|
Blood and lymphatic system disorders
AST (SGOT)
|
54.5%
6/11 • 0-12 weeks
|
|
Renal and urinary disorders
Proteinuria
|
81.8%
9/11 • 0-12 weeks
|
|
Blood and lymphatic system disorders
Sodium-serum, low
|
63.6%
7/11 • 0-12 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place