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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00676650




Registration number
NCT00676650
Ethics application status
Date submitted
8/05/2008
Date registered
13/05/2008
Date last updated
8/03/2013

Titles & IDs
Public title
Sunitinib Plus Prednisone In Patients With Metastatic Castration-Resistant Prostate Cancer After Failure Of Docetaxel Chemotherapy
Scientific title
A Multicenter, Randomized, Double-Blind, Phase 3 Study Of Sunitinib Plus Prednisone Versus Prednisone In Patients With Progressive Metastatic Castration-Resistant Prostate Cancer After Failure Of A Docetaxel-Based Chemotherapy Regimen
Secondary ID [1] 0 0
A6181120
Universal Trial Number (UTN)
Trial acronym
SUN 1120
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prostatic Neoplasms 0 0
Condition category
Condition code
Cancer 0 0 0 0
Prostate

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Prednisone
Treatment: Drugs - sunitinib
Treatment: Drugs - Placebo
Treatment: Drugs - Prednisone

Experimental: A - Treatment Arm A - sunitinib + prednisone

Placebo Comparator: B - Treatment Arm B - placebo + prednisone


Treatment: Drugs: Prednisone
5 mg BID, oral

Treatment: Drugs: sunitinib
37.5 mg/day, oral, administered on a continuous daily dosing regimen

Treatment: Drugs: Placebo
37.5 mg/day, oral, administered on a continuous daily dosing regimen

Treatment: Drugs: Prednisone
5 mg BID, oral

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Overall Survival (OS) - OS is the duration from randomization to death. For participants who were alive, overall survival was censored at the last contact. OS (in months) calculated as (date of death minus [-] date of randomization plus [+] 1) divided (/) 30.4.
Timepoint [1] 0 0
Baseline up to 32 months
Secondary outcome [1] 0 0
Progression-Free Survival (PFS) - PFS is the period from randomization until disease progression or death on study. PFS is censored on the date of last tumor assessment documenting absence of progressive disease. PFS (weeks) calculated as (first event date - randomization date + 1)/7.02
Timepoint [1] 0 0
Baseline, every 8 weeks up to 123 weeks
Secondary outcome [2] 0 0
Percent of Participants With Objective Response (OR) - OR defined as the percent (%) of participants with confirmed Complete Response (CR) (disappearance of all target lesions) or Partial Response (PR) (>=30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions) according to Response Evaluation Criteria in Solid Tumors (RECIST), relative to the full analysis population. Confirmed responses were those that persist on repeat imagining study >= 4 weeks after initial documentation of response.
Timepoint [2] 0 0
Baseline, every 8 weeks up to 123 weeks
Secondary outcome [3] 0 0
Duration of Response (DR) - Time in weeks from the first documentation of objective tumor response to objective tumor progression or death due to any cause. Duration of tumor response was calculated as (the date of the first documentation of objective tumor progression or death due to cause - the date of the first CR or PR that was subsequently confirmed plus 1 divided by 7.02. DR calculated for the subgroup of participants with a confirmed objective tumor response
Timepoint [3] 0 0
Baseline, every 8 weeks up to 123 weeks
Secondary outcome [4] 0 0
Change From Baseline in Pain Severity - Pain severity recorded on a numerical scale ranging from 0 (no pain) to 10 (pain as bad as you can imagine). Higher scores indicated greater level of pain. The pain score for each cycle averaged for the 7 days.
Timepoint [4] 0 0
Day 1 through Day 7 every 28 days (every cycle) up to 29 months
Secondary outcome [5] 0 0
Change From Baseline in Functional Assessment of Cancer Therapy-Prostate (FACT-P) - FACT-P is a validated, self-administered instrument used to assess health-related quality of life and prostate cancer-specific symptoms. Scores ranged from 0 (not at all) to 4 (very much). It is 27-item FACT-General and 12 items for the prostate cancer specific concerns. The 27 items in FACT-G are grouped into 4 domains: physical well-being, social/family well-being, emotional well-being and functional well-being. The 12 prostate cancer symptoms items focus on pain (3 items), urination problems (3 items), sexual functions (2 items), weight loss, appetite, overall comfort, and bowel movement.
Timepoint [5] 0 0
Baseline, every 4 weeks up to 123 weeks
Secondary outcome [6] 0 0
Change From Baseline in Euro Quality of Life (EQ-5D)- Health State Profile Utility Score - EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state ("confined to bed"). Overall scores range from 0 to 1, with lower scores representing a higher level of dysfunction.
Timepoint [6] 0 0
Baseline, every 4 weeks up to 123 weeks

Eligibility
Key inclusion criteria
- Histologically or cytologically confirmed adenocarcinoma of the prostate.

- Progressive, metastatic castration-resistant prostate cancer after failure of
docetaxel chemotherapy (resistant or intolerant).

- Progressive disease based on PSA progression, RECIST, or positive bone scan.

- ECOG 0 or 1.
Minimum age
18 Years
Maximum age
No limit
Gender
Males
Can healthy volunteers participate?
No
Key exclusion criteria
- Prior treatment with sunitinib and/or more than 1 prior chemotherapy regimen in the
metastatic disease setting.

- Chemotherapy within 3 weeks.

- Impending complications from bone metastases.

- Ongoing urinary obstruction.

- Cardiac dysfunction, QTc >470 msec.

- CNS involvement.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Terminated
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
Pfizer Investigational Site - Port Macquarie
Recruitment hospital [2] 0 0
Pfizer Investigational Site - Wahroong
Recruitment hospital [3] 0 0
Pfizer Investigational Site - Westmead
Recruitment hospital [4] 0 0
Pfizer Investigational Site - Wodonga
Recruitment postcode(s) [1] 0 0
2444 - Port Macquarie
Recruitment postcode(s) [2] 0 0
2076 - Wahroong
Recruitment postcode(s) [3] 0 0
2145 - Westmead
Recruitment postcode(s) [4] 0 0
3690 - Wodonga
Recruitment outside Australia
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Pfizer
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This study will compare the safety and efficacy of sunitinib in combination with prednisone
versus placebo and prednisone in patients that have metastatic castration-resistant prostate
cancer that has progressed after treatment with a docetaxel-containing chemotherapy regimen.
This is a second-line study.
Trial website
https://clinicaltrials.gov/show/NCT00676650
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Pfizer CT.gov Call Center
Address 0 0
Pfizer
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT00676650