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Saracatinib in Treating Patients With Prostate Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01267266
Recruitment Status : Terminated (Per protocol, study was terminated due to low rate of randomized patients.)
First Posted : December 28, 2010
Results First Posted : April 1, 2015
Last Update Posted : April 1, 2015
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Hormone-resistant Prostate Cancer Recurrent Prostate Cancer Stage IV Prostate Cancer Drug: saracatinib Other: hydrocortisone/placebo Phase 2

Detailed Description:


I. Determine if AZD0530 (saracatinib) increases time to radiographic progression in men with CRPC compared to placebo.


I. Describe the adverse events related to AZD0530 in this population. II. Explore the role of FYN and other SRC kinase expression as a predictor of response to AZD0530.

OUTLINE: This is a multicenter study.

LEAD-IN PHASE: Patients receive oral saracatinib once daily during for 8 weeks. Patients who achieve disease regression or a PSA decrease of > 50% continue to receive open-label saracatinib. Patients who do not show radiographic evidence of new metastases on bone scan and CT, disease regression, or a > 50% decrease in PSA continue on to the randomized phase.

RANDOMIZED PHASE: Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients 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: Patients 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.

Tissue samples may be collected for correlative studies. After completion of study treatment, patients are followed up for 12 months.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 31 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Discontinuation Phase 2 Study of AZD0530 as a Metastasis Inhibitor in Castrate Resistant Prostate Cancer
Study Start Date : December 2010
Primary Completion Date : September 2012
Study Completion Date : November 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Arm I (saracatinib)
Patients receive oral saracatinib once daily on days 1-28. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
Drug: saracatinib
Given orally
Other Name: AZD0530
Placebo Comparator: Arm II (placebo)
Patients 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.
Other: hydrocortisone/placebo
Given orally

Outcome Measures

Primary Outcome Measures :
  1. Duration of Stable Disease. (Time to Disease Progression by CT and/or Bone Scan or Clinical Progression.) [ Time Frame: Up to 6 months. ]
    Time to progression will be assessed using the Kaplan-Meier method and compared between groups via Wilcoxon rank-sum test.

Secondary Outcome Measures :
  1. Toxicity and Incidence of Adverse Events [ Time Frame: Up to 6 months. ]
    Percentage of patients with grade 4 toxicity.

  2. Toxicity and Incidence of Adverse Events. [ Time Frame: Up to 6 months. ]
    Percentage of patients who discontinued therapy due to toxicity.

  3. Correlation of Molecular Profile With Clinical Outcomes [ Time Frame: Up to 2 years ]
    Study terminated after randomization of only 8 subjects. Correlative data not analyzed.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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
  • Previous AZD0530 exposure is allowed provided that the patient did not show radiographic progression during treatment
  • Patients receiving non-steroidal anti-androgens (e.g., flutamide) or other hormonal treatment (such as ketoconazole, abiraterone, or TAK-700) must have stopped these drugs at least 28 days prior to enrollment for flutamide or ketoconazole, or at least 42 days prior to enrollment for bicalutamide or nilutamide, and the patients must have demonstrated progression of disease since the agents were suspended
  • Patients should be at least 2 weeks away from previous chemotherapy, surgery, or radiotherapy
  • No unresolved toxicity from previous treatments that are CTCAE grade 2 from previous anti-cancer therapy (except alopecia)
  • Patients who are currently on zoledronic acid (Zometa) or other bisphosphonate therapy are eligible provided that they have been on therapy at least 6 weeks prior to participation

    • Increases in bisphosphonate dosing will not be allowed (i.e., starting within 6 weeks or changing from every 3-month to every 1-month dosing)
  • Use of specifically prohibited CYP3A4-active agents or substances are not permitted during protocol treatment, and patients who must continue treatment with these agents are not eligible

    • Prohibited drugs should be discontinued 7 days prior to the administration of the first dose of AZD0530 and for 7 days following discontinuation of AZD0530 (unless otherwise specified)
  • No concurrent use of non-FDA approved medications
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01267266

United States, Illinois
University of Chicago
Chicago, Illinois, United States, 60637
Decatur Memorial Hospital
Decatur, Illinois, United States, 62526
NorthShore University HealthSystem-Evanston Hospital
Evanston, Illinois, United States, 60201
Ingalls Memorial Hospital
Harvey, Illinois, United States, 60426
Loyola University Medical Center
Maywood, Illinois, United States, 60153
Illinois CancerCare-Peoria
Peoria, Illinois, United States, 61615
Central Illinois Hematology Oncology Center
Springfield, Illinois, United States, 60702
Southern Illinois University
Springfield, Illinois, United States, 62702
United States, Indiana
Fort Wayne Medical Oncology and Hematology Inc-Parkview
Fort Wayne, Indiana, United States, 46845
United States, Maryland
University of Maryland Greenebaum Cancer Center
Baltimore, Maryland, United States, 21201-1595
United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109
United States, Missouri
Saint John's Mercy Medical Center
Saint Louis, Missouri, United States, 63141
United States, Texas
M D Anderson Cancer Center
Houston, Texas, United States, 77030
United States, Wisconsin
University of Wisconsin Women's Health Center
Madison, Wisconsin, United States, 53715
Froedtert and the Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Sponsors and Collaborators
National Cancer Institute (NCI)
Principal Investigator: Walter Stadler University of Chicago
More Information

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT01267266     History of Changes
Other Study ID Numbers: NCI-2011-02563
NCI-2011-02563 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
10-436-B ( Other Identifier: University of Chicago )
8446 ( Other Identifier: CTEP )
N01CM00099 ( U.S. NIH Grant/Contract )
N01CM00071 ( U.S. NIH Grant/Contract )
U01CA062491 ( U.S. NIH Grant/Contract )
P30CA014599 ( U.S. NIH Grant/Contract )
First Posted: December 28, 2010    Key Record Dates
Results First Posted: April 1, 2015
Last Update Posted: April 1, 2015
Last Verified: January 2013

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases
Hydrocortisone 17-butyrate 21-propionate
Hydrocortisone acetate
Cortisol succinate
Anti-Inflammatory Agents
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action