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Phase II Sunitinib Prog Met AIPC

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ClinicalTrials.gov Identifier: NCT00599313
Recruitment Status : Completed
First Posted : January 23, 2008
Results First Posted : December 8, 2016
Last Update Posted : October 25, 2018
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
US Oncology Research

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Metastatic Prostate Cancer
Intervention Drug: Sunitinib
Enrollment 36
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Sunitinib Malate
Hide Arm/Group Description Sunitinib Malate (Sutent) (50 mg/day on Days 1-28 of 42-day cycles)
Period Title: Overall Study
Started 36
Completed 0
Not Completed 36
Reason Not Completed
Adverse Event             19
Disease Progression             12
Patient Request             4
Ineligible             1
Arm/Group Title Sunitinib Malate
Hide Arm/Group Description Sunitinib Malate (Sutent) (50 mg/day on Days 1-28 of 42-day cycles)
Overall Number of Baseline Participants 36
Hide Baseline Analysis Population Description
Total participants
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 36 participants
70.0  (9.34)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 36 participants
Female
0
   0.0%
Male
36
 100.0%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 36 participants
Caucasian 32
Black 3
Hispanic 1
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 36 participants
36
1.Primary Outcome
Title Median Progression-free Survival (PFS) Time at 1-year.
Hide Description

PFS is measured from the date of registration to the date of first documented disease progression or date of death, whichever comes first. If a patient neither progresses nor dies, this patient will be censored at last contact date.

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.

Time Frame 12 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT population
Arm/Group Title Sunitinib Malate
Hide Arm/Group Description:
Sunitinib Malate (Sutent) (50 mg/day on Days 1-28 of 42-day cycles)
Overall Number of Participants Analyzed 36
Median (Full Range)
Unit of Measure: weeks
19.4
(2.6 to 48.3)
2.Secondary Outcome
Title Overal Survival (OS) Rate at 1-year.
Hide Description OS is measured from the date of randomization to the date of death for a dead patient. If a patient is still alive or is lost to follow up, the patient will be censored at the last contact date.
Time Frame 12 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT population
Arm/Group Title Sunitinib Malate
Hide Arm/Group Description:
Sunitinib Malate (Sutent) (50 mg/day on Days 1-28 of 42-day cycles)
Overall Number of Participants Analyzed 36
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Probability of Survival at 1-year
0.42
(0.23 to 0.60)
3.Secondary Outcome
Title Prostate Specific Antigen (PSA) Response
Hide Description Percentage of participants whose PSA value declined to 50% when compared to the value at the baseline.
Time Frame Baseline and up to 12 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Evaluable population
Arm/Group Title Sunitinib Malate
Hide Arm/Group Description:
Sunitinib Malate (Sutent) (50 mg/day on Days 1-28 of 42-day cycles)
Overall Number of Participants Analyzed 33
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
12.1
(3.4 to 28.2)
4.Secondary Outcome
Title Change of PSA Doubling Time
Hide Description Difference of PSA doubling time between baseline and end of the treatment.
Time Frame Baseline and up to 12 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Patients who had measurements of prior and post doubling time.
Arm/Group Title Sunitinib Malate
Hide Arm/Group Description:
Sunitinib Malate (Sutent) (50 mg/day on Days 1-28 of 42-day cycles)
Overall Number of Participants Analyzed 25
Median (Full Range)
Unit of Measure: months
0.5
(-5.1 to 43.7)
5.Secondary Outcome
Title Objective Response Rate (ORR)
Hide Description ORR = Complete Response (CR) + Partial response (PR). CR: Disappearance of all target lesions. PR: At least a 30% decrease in the sum of the LD of target lesions taking as reference the baseline sum LD.
Time Frame 12 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Only patients with baseline measurable lesions.
Arm/Group Title Sunitinib Malate
Hide Arm/Group Description:
Sunitinib Malate (Sutent) (50 mg/day on Days 1-28 of 42-day cycles)
Overall Number of Participants Analyzed 18
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
11.1
(1.4 to 34.7)
6.Secondary Outcome
Title Percentage of Participants With Decrease in Present Pain Intensity (PPI) From Baseline.
Hide Description Pain score decreased >=2 points from baseline. The PPI scale has the following descriptors: 0=no pain, 1=mild pain, 2=discomforting pain, 3=distressing pain, 4=horrible pain, and 5=excruciating pain. The patient will be asked to self-assess and record their PPI in the study diary. Upon diary review, the study nurse will utilize the PPI daily scores to calculate the week’s average. The weekly PPI score during the study is the average of the daily PPI scores, based on a minimum of 3 daily PPI assessments during a week’s period.
Time Frame Baseline and up to 12 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Patients with pain measurement at baseline.
Arm/Group Title Sunitinib Malate
Hide Arm/Group Description:
Sunitinib Malate (Sutent) (50 mg/day on Days 1-28 of 42-day cycles)
Overall Number of Participants Analyzed 22
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
13.6
(6.3 to 20.9)
Time Frame During the whole treatment period, up to 30 days following last dose.
Adverse Event Reporting Description For treated patients only, assessed at each treatment visit.
 
Arm/Group Title Sunitinib Malate
Hide Arm/Group Description Sunitinib Malate (Sutent) (50 mg/day on Days 1-28 of 42-day cycles)
All-Cause Mortality
Sunitinib Malate
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Sunitinib Malate
Affected / at Risk (%) # Events
Total   7/35 (20.00%)    
Gastrointestinal disorders   
ABDOMINAL PAIN  1  1/35 (2.86%)  1
DEHYDRATION  1  1/35 (2.86%)  1
DIARRHEA  1  2/35 (5.71%)  2
NAUSEA  1  1/35 (2.86%)  1
NAUSEA AND VOMITING  1  1/35 (2.86%)  1
VOMITING  1  1/35 (2.86%)  1
Infections and infestations   
SEPSIS  1  1/35 (2.86%)  1
Musculoskeletal and connective tissue disorders   
BACK PAIN  1  1/35 (2.86%)  1
Renal and urinary disorders   
FAILURE KIDNEY ACUTE  1  1/35 (2.86%)  1
Respiratory, thoracic and mediastinal disorders   
SHORTNESS OF BREATH  1  1/35 (2.86%)  1
THROMBOSIS PULMONARY  1  1/35 (2.86%)  1
Vascular disorders   
STROKE  1  1/35 (2.86%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, COSTART, CTCAE v3.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Sunitinib Malate
Affected / at Risk (%) # Events
Total   29/35 (82.86%)    
Blood and lymphatic system disorders   
ANEMIA  1  13/35 (37.14%)  17
EDEMA  1  2/35 (5.71%)  2
LEUCOPENIA  1  5/35 (14.29%)  14
NEUTROPENIA  1  11/35 (31.43%)  16
THROMBOCYTOPENIA  1  4/35 (11.43%)  8
Gastrointestinal disorders   
ANOREXIA  1  13/35 (37.14%)  18
CONSTIPATION  1  2/35 (5.71%)  2
DIARRHEA  1  11/35 (31.43%)  13
DYSGUESIA  1  3/35 (8.57%)  3
MUCOSITIS  1  6/35 (17.14%)  9
NAUSEA  1  12/35 (34.29%)  20
STOMATITIS  1  2/35 (5.71%)  2
VOMITING  1  5/35 (14.29%)  5
General disorders   
FATIGUE  1  16/35 (45.71%)  25
MALAISE  1  2/35 (5.71%)  2
WEIGHT LOSS  1  4/35 (11.43%)  4
Metabolism and nutrition disorders   
ALKALINE PHOSPHASTASE SERUM INCREASE  1  2/35 (5.71%)  2
Musculoskeletal and connective tissue disorders   
MUSCLE WEAKNESS  1  2/35 (5.71%)  4
MYALGIA  1  4/35 (11.43%)  4
Nervous system disorders   
NEUROPATHY  1  2/35 (5.71%)  3
Skin and subcutaneous tissue disorders   
HAND-FOOT SYNDROME  1  3/35 (8.57%)  3
RASH  1  6/35 (17.14%)  6
Vascular disorders   
HYPERTENSION  1  3/35 (8.57%)  3
Indicates events were collected by systematic assessment
1
Term from vocabulary, COSTART, CTCAE v3.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Dr. Guru Sonpavde
Organization: Texas Oncology Cancer Center
Phone: 2813327505
Responsible Party: US Oncology Research
ClinicalTrials.gov Identifier: NCT00599313     History of Changes
Other Study ID Numbers: 05112
2006-0012 ( Other Identifier: Pfizer )
First Submitted: January 11, 2008
First Posted: January 23, 2008
Results First Submitted: January 20, 2016
Results First Posted: December 8, 2016
Last Update Posted: October 25, 2018