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

Marshall Edwards Pty Ltd0 个研究点目标入组 24 人开始时间: 2005年9月26日最近更新: 2020年1月13日

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•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.

•a) Patients may not be on a concurrent investigational drug study and must be off treatment with any investigational agents for at least 4 weeksb) Patients may not have active infectionc) Patients may not have active CNS metastases. Patients with known CNS metastases must have received prior radiation therapy, and CNS metastatic disease must be stable for 4 weeks.d) Patients must have recovered from the effects of any prior anti-neoplastic therapy.

发起方

Marshall Edwards Pty Ltd