Phase 1/2 Pharmacokinetic and Safety Study of Oral Phenoxodiol in Patients with Hormone-Refractory Prostatic Adenocarcinoma

Inclusion Criteria1

• a) Patients must have histological evidence of prostatic adenocarcinomab) Patients must have a malignancy that, in the opinion of the investigator, has become refractory to standard therapy including hormonal therapy c)Patients must be able to understand the risks and benefits of the study and give written informed consent to participation d) Patients must have an estimated life-expectancy of at least 3 months e) Patients must have -acceptable renal and hepatic function evidenced by a serum creatinine < 0.12mmol/L and serum transaminase levels <3 x the upper limit of normal for the reference laboratory-bilirubin < 20umol/L-adequate haematological function defined by platelets > 100x109/L , WCC > 4x109/L, Hb > 10g/dL, neutrophils > 1.5 x 109 /L f) Patients engaging in sexual activity must (i) agree to use contraception, or (ii) ensure that their sexual partner be using contraception which must be either oral contraceptives, implantable hormonal contraceptives, or double-barrier methods, if of child-bearing potential.