Clinical trial NCT00513071 (phase 2, status: completed)
Conditions: hormone-resistant prostate cancer, recurrent prostate cancer
ICD codes: C61, D29.1, D40.0, Z15.03, Z80.42, Z85.46, Z12.5, C61, D29.1, D40.0, Z15.03, Z80.42, Z85.46, Z12.5
Drugs: saracatinib
SMILES: CN1CCN(CCOC2=CC3=C(C(NC4=C(Cl)C=CC5=C4OCO5)=NC=N3)C(OC3CCOCC3)=C2)CC1
Eligibility criteria:

        Inclusion Criteria:

          -  Histologically or cytologically confirmed prostate cancer with a Gleason score
             available or interpretable and meeting 1 of the following criteria:

               -  No prior chemotherapy and relatively minimal cancer spread

               -  Only one prior taxane-based chemotherapy for aggressive and/or symptomatic
                  disease

          -  Must have prostate cancer considered to be hormone refractory or androgen independent
             by one or more of the following criteria (despite androgen deprivation and
             anti-androgen withdrawal when applicable):

               -  Progression of unidimensionally measurable disease assessed within 28 days prior
                  to initial administration of drug

               -  Progression of evaluable but not measurable disease assessed within 28 days prior
                  to initial administration of drug for PSA evaluation and within 42 days for
                  imaging studies (e.g., bone scans)

          -  Patients must have nonmeasurable disease (e.g., nuclear medicine bone scans) and
             non-target lesions (e.g., PSA level) assessed within 28 days prior to initial
             administration of drug

               -  Measurable disease is not required but is allowed

          -  Must be surgically or medically castrated

               -  If the method of castration was luteinizing hormone-releasing hormone (LHRH)
                  agonists (e.g., leuprolide or goserelin), then the patient must be willing to
                  continue the use of LHRH agonists

               -  Serum testosterone must be at castrate levels (< 50 ng/dL) at least 3 months
                  prior to registration

          -  ECOG performance status 0-2

          -  WBC >= 3,000/uL

          -  Absolute neutrophil count >= 1,500/uL

          -  Platelets >= 100,000/uL

          -  Hemoglobin > 9 g/d

          -  Total bilirubin within normal institutional limits

          -  AST/ALT =< 2.5 x institutional upper limit of normal

          -  Creatinine within normal institutional limits OR creatinine clearance >= 60 mL/min

          -  Must agree to use adequate contraception prior to study entry and for the duration of
             study participation

          -  At least 3 weeks since the completion of chemotherapy and radiotherapy and the patient
             must have recovered from the side effects of the therapy

          -  At least 28 days since prior non-steroidal anti-androgens (e.g., flutamide) (42 days
             for bicalutamide or nilutamide) or hormonal treatment (e.g., ketoconazole) and
             demonstrated progression of disease since the agents were suspended

          -  Concurrent bisphosphonate therapy is allowed

        Exclusion Criteria:

          -  Known brain metastases

          -  History of allergic reactions attributed to compounds of similar chemical or
             biological composition to AZD0530

          -  Patients with any of the following conditions that impair the ability to swallow
             AZD0530 tablets

               -  Gastrointestinal tract disease resulting in an inability to take oral medication
                  or requiring IV alimentation

               -  Prior surgical procedures affecting absorption

               -  Active peptic ulcer disease

          -  Uncontrolled intercurrent illness including, but not limited to, ongoing or active
             infection or psychiatric illness/social situations that would limit compliance with
             study requirements

          -  Patients who have not recovered from adverse events due to agents administered more
             than 4 weeks earlier

          -  Use of specifically prohibited CYP3A4-active agents or substances

               -  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

          -  Patients receiving any other investigational agents

          -  No investigational or commercial agents or therapies other than study drugs may be
             administered with the intent to treat the patient's malignancy

          -  HIV-positive patients on combination antiretroviral therapy