Phase II Sunitinib Prog Met AIPC
|ClinicalTrials.gov Identifier: NCT00599313|
Recruitment Status : Completed
First Posted : January 23, 2008
Results First Posted : December 8, 2016
Last Update Posted : October 25, 2018
|Condition or disease||Intervention/treatment||Phase|
|Metastatic Prostate Cancer||Drug: Sunitinib||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||36 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Trial of Sunitinib Malate for the Therapy of Progressive Metastatic Androgen Independent Prostate Cancer (AIPC) Following Docetaxel-based Chemotherapy|
|Study Start Date :||March 2007|
|Actual Primary Completion Date :||June 2009|
|Actual Study Completion Date :||June 2009|
Experimental: Sunitinib Malate
Sunitinib Malate (Sutent) (50 mg/day on Days 1-28 of 42-day cycles)
50 mg/day orally each of Days 1-28 of each 6 week cycle
- Median Progression-free Survival (PFS) Time at 1-year. [ Time Frame: 12 months ]
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.
- Overal Survival (OS) Rate at 1-year. [ Time Frame: 12 months ]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.
- Prostate Specific Antigen (PSA) Response [ Time Frame: Baseline and up to 12 months ]Percentage of participants whose PSA value declined to 50% when compared to the value at the baseline.
- Change of PSA Doubling Time [ Time Frame: Baseline and up to 12 months ]Difference of PSA doubling time between baseline and end of the treatment.
- Objective Response Rate (ORR) [ Time Frame: 12 months ]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.
- Percentage of Participants With Decrease in Present Pain Intensity (PPI) From Baseline. [ Time Frame: Baseline and up to 12 months ]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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00599313
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|Principal Investigator:||Guru Sonpavde, MD||US Oncology Research|