Saracatinib in Treating Patients With Prostate Cancer

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Hormone-resistant Prostate Cancer, Recurrent Prostate Cancer, Stage IV Prostate Cancer

In brief

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.

Key facts

Study ID: NCT01267266
Run by: National Cancer Institute (NCI)
People needed: 31
Starts: 2010-12-01
Expected to finish: 2013-11-01
Last updated by the study team: 2015-04-01

Who can join

Age: any. Sex: male. Healthy volunteers: not accepted.

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
Treatment in the adjuvant or neoadjuvant setting will NOT be grounds for inclusion unless docetaxel has been used again in the setting of progressive CRPC
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
No patients with any condition (e.g., gastrointestinal tract disease resulting in an inability to take oral medication or a requirement for IV alimentation, prior surgical procedures affecting absorption, or active peptic ulcer disease) that impairs the ability to swallow AZD0530 tablets
No history of uncontrolled or unstable cardiac dysrhythmia
No resting ECG with measurable QTc interval of > 480 msec at 2 or more time points within a 24-hour period
No evidence of interstitial lung disease (bilateral, diffuse, parenchymal lung disease)
A high-resolution CT of the chest will be required during screening
No evidence of severe or uncontrolled systemic conditions (e.g., severe hepatic impairment) or current unstable or uncompensated respiratory or cardiac conditions which makes it undesirable for the patient to participate in the study or which could jeopardize compliance with the protocol
No patients with a known immunodeficiency syndrome
No patients with a history of allergic reactions attributed to compounds of similar chemical or biologic composition to AZD0530
No patients receiving any other investigational agents

Where it is running

University of Chicago — Chicago, Illinois, United States
Decatur Memorial Hospital — Decatur, Illinois, United States
NorthShore University HealthSystem-Evanston Hospital — Evanston, Illinois, United States
Ingalls Memorial Hospital — Harvey, Illinois, United States
Loyola University Medical Center — Maywood, Illinois, United States
Illinois CancerCare-Peoria — Peoria, Illinois, United States
Central Illinois Hematology Oncology Center — Springfield, Illinois, United States
Southern Illinois University — Springfield, Illinois, United States
Fort Wayne Medical Oncology and Hematology Inc-Parkview — Fort Wayne, Indiana, United States
University of Maryland Greenebaum Cancer Center — Baltimore, Maryland, United States
University of Michigan — Ann Arbor, Michigan, United States
Saint John's Mercy Medical Center — St Louis, Missouri, United States
M D Anderson Cancer Center — Houston, Texas, United States
University of Wisconsin Women's Health Center — Madison, Wisconsin, United States
Froedtert and the Medical College of Wisconsin — Milwaukee, Wisconsin, United States

Full record on ClinicalTrials.gov

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