Clinical trial NCT02064608 (phase 1, status: completed)
Conditions: prostate cancer
ICD codes: C61, D29.1, D40.0, Z15.03, Z80.42, Z85.46, Z12.5
Drugs: azd2014
SMILES: [H][C@@]1(C[C@@H](C)[C@]2([H])CC(=O)[C@H](C)\C=C(C)\[C@@H](O)[C@@H](OC)C(=O)[C@H](C)C[C@H](C)\C=C\C=C\C=C(C)\[C@H](C[C@]3([H])CC[C@@H](C)[C@@](O)(O3)C(=O)C(=O)N3CCCC[C@@]3([H])C(=O)O2)OC)CC[C@@H](OCCO)[C@@H](C1)OC
Eligibility criteria:

        Inclusion Criteria:

          -  Men aged 18 years old or older

          -  ECOG performance status of 0 or 1

          -  Clinical diagnosis of Intermediate (one or more of stage T2, or PSA >10ng/mL, or
             Gleason score of at least 7) or High Risk Prostate Cancer (one or more of stage T2c,
             or PSA >20ng/mL, or Gleason score of at least 8)

          -  Patient suitable for radical prostatectomy, following discussion at specialist MDT and
             subsequent review by surgical team

          -  Willing to use barrier contraceptive method, e.g. condom & spermicide

          -  Adequate bone marrow reserve or organ function (as specified in the study protocol)

          -  Normal chest radiograph and oxygen saturations, OR normal CT thorax

        Exclusion Criteria:

          -  Contraindication to AZD2014 (as specified in the study protocol)

          -  Patients who have experienced any of the following procedures in the past 12 months:
             coronary artery bypass graft; angioplasty; vascular stent; myocardial infarction;
             angina pectoris; congestive heart failure (New York Heart Association grade of 2 or
             above); ventricular arrhythmias requiring continuous therapy; supraventricular
             arrhythmias including atrial fibrillation, which are uncontrolled; haemorrhagic or
             thrombotic stroke including transient ischaemic attacks or any other CNS bleeding.

          -  Previous chemotherapy, biological therapy, radiation therapy, androgens, thalidomide,
             immunotherapy, other anticancer agents and/or investigational agents within 28 days of
             starting study treatment.

          -  Major surgery within 4 weeks prior to study entry (excluding placement of vascular
             access), or minor surgery within 2 weeks of entry into the study

          -  Potent or moderate inhibitors and inducers of CYP2C8 if taken within the stated
             wash-out period: Gemfibrozil, trimethoprim, glitazones, montelukast, deferasirox and
             quercetin (1-week minimum wash out period)

          -  Any haematopoietic growth factors, e.g. G-CSF, GM-CSF, within 4 weeks prior to
             receiving study drug

          -  As judged by the Investigator, any evidence of severe or uncontrolled systemic disease
             (as specified in the study protocol)

          -  Abnormal ECHO or MUGA at baseline

          -  Mean resting QTc of 470msec or above (as per local reading)

          -  Concomitant medications known to prolong QT interval, or with factors that increase
             the risk of QTc prolongation, or risk of arrythmic events (examples specified in study
             protocol). History of Torsades de Pointes.

          -  Patients with Diabetes Type I or uncontrolled Type II as judged by the investigator

          -  Judgement by the investigator that the patient is unsuitable to participate in the
             study and the patient is unlikely to comply with study procedures, restrictions and
             requirements.

          -  Unable to provide informed consent