Study Stopped
Per protocol, study was terminated due to low rate of randomized patients.
Saracatinib in Treating Patients With Prostate Cancer
A Randomized Discontinuation Phase 2 Study of AZD0530 as a Metastasis Inhibitor in Castrate Resistant Prostate Cancer
8 other identifiers
interventional
31
1 country
15
Brief Summary
This randomized phase II clinical trial is studying how well saracatinib works in treating patients with prostate cancer. Saracatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Dec 2010
Typical duration for phase_2
15 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2010
CompletedFirst Submitted
Initial submission to the registry
December 24, 2010
CompletedFirst Posted
Study publicly available on registry
December 28, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2013
CompletedResults Posted
Study results publicly available
April 1, 2015
CompletedApril 1, 2015
January 1, 2013
1.8 years
December 24, 2010
January 30, 2015
March 18, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Duration of Stable Disease. (Time to Disease Progression by CT and/or Bone Scan or Clinical Progression.)
Time to progression will be assessed using the Kaplan-Meier method and compared between groups via Wilcoxon rank-sum test.
Up to 6 months.
Secondary Outcomes (3)
Toxicity and Incidence of Adverse Events
Up to 6 months.
Toxicity and Incidence of Adverse Events.
Up to 6 months.
Correlation of Molecular Profile With Clinical Outcomes
Up to 2 years
Study Arms (2)
Arm I (saracatinib)
EXPERIMENTALPatients receive oral saracatinib once daily on days 1-28. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
Arm II (placebo)
PLACEBO COMPARATORPatients receive oral placebo once daily on days 1-28. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Upon progression, patients may crossover to arm I.
Interventions
Eligibility Criteria
You may qualify if:
- Histologically or cytologically confirmed prostate cancer with progressive disease; progressive disease may be defined as either
- New clinical or radiographic metastases
- Rising PSA: PSA must be greater than 1.0 ng/mL with at least 2 consecutive rises after completion of prior therapy; the PSA values documenting these rises should be separated by no less than 10 days; the baseline PSA value may be taken from the end of prior therapy
- Previous treatment with docetaxel for disease progression following hormonal therapy (i.e., castrate-resistant disease) required
- ECOG performance status 0-1
- ANC ≥ 1,500/mm³
- Hemoglobin \> 9.0 g/dL
- Platelet count \> 100,000/mm³
- Total bilirubin \< 2.0 x institutional ULN
- AST/ALT \< 5 x institutional ULN in the presence of bone/liver metastases
- Serum creatinine (Cr) within ULN
- Patients with Cr \> ULN must have a Cr clearance of \> 60 mL/min
- Testosterone 50 ng/mL or lower if a patient is receiving an LHRH agonist
- No testosterone testing is required for men who have undergone surgical orchiectomy
- Fertile patients must agree to abstinence or some adequate form of contraception
- +18 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (15)
University of Chicago
Chicago, Illinois, 60637, United States
Decatur Memorial Hospital
Decatur, Illinois, 62526, United States
NorthShore University HealthSystem-Evanston Hospital
Evanston, Illinois, 60201, United States
Ingalls Memorial Hospital
Harvey, Illinois, 60426, United States
Loyola University Medical Center
Maywood, Illinois, 60153, United States
Illinois CancerCare-Peoria
Peoria, Illinois, 61615, United States
Central Illinois Hematology Oncology Center
Springfield, Illinois, 60702, United States
Southern Illinois University
Springfield, Illinois, 62702, United States
Fort Wayne Medical Oncology and Hematology Inc-Parkview
Fort Wayne, Indiana, 46845, United States
University of Maryland Greenebaum Cancer Center
Baltimore, Maryland, 21201-1595, United States
University of Michigan
Ann Arbor, Michigan, 48109, United States
Saint John's Mercy Medical Center
St Louis, Missouri, 63141, United States
M D Anderson Cancer Center
Houston, Texas, 77030, United States
University of Wisconsin Women's Health Center
Madison, Wisconsin, 53715, United States
Froedtert and the Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Walter M. Stadler
- Organization
- University of Chicago
Study Officials
- PRINCIPAL INVESTIGATOR
Walter Stadler
University of Chicago
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 24, 2010
First Posted
December 28, 2010
Study Start
December 1, 2010
Primary Completion
September 1, 2012
Study Completion
November 1, 2013
Last Updated
April 1, 2015
Results First Posted
April 1, 2015
Record last verified: 2013-01