Safety, Tolerability and Pharmacokinetics of ONC1-0013B in Patients With Progressive Metastatic Castration-resistant Prostate Cancer

Inclusion criteria

• Men aged 18 years and older.
• Histologically confirmed diagnosis of prostate cancer
• Castrate level of testosterone in blood serum < 1,7 nmol/l or < 50 ng/dl
• PSA level at screening > 2 ng/ml
• Progression of metastatic CRPC after the chemical castration with gonadotropin-releasing hormone (GnRH) analogue or after the chemical castration and subsequent chemotherapy.
• The patient's ECOG performance status of 0 - 2
• Patients previously treated with docetaxel chemotherapy should have received 2 or less prior lines of chemotherapy for mCRPC
• The expected survival time of not less than 12 weeks

Exclusion criteria

• Prior anticancer therapy:

• Treatment with chemotherapeutic agents or radiotherapy within 4 weeks prior to screening or preserved toxicities of ≥ II grade according to CTCAE scale, related to prior anticancer therapy (excluding alopecia)
• Prior antiandrogen therapy: flutamide within 4 weeks prior to screening or bicalutamide within 6 weeks prior to screening
• Exposure to bisphosphonates is allowed only if the treatment started prior to screening
• Clinically significant cardiovascular system diseases:
• Clinically significant central nervous system diseases:
• History of other significant concomitant diseases which, in the Investigator's opinion, may cause a disease recurrence (i.e. uncontrolled diabetes mellitus)
• Prior or concomitant therapy:

• Exposure to drugs which may cause a convulsive state within 4 weeks prior to screening
• Exposure to treatment with characteristics of CYP3A4 or CYP2D6 inhibitors within 4 weeks prior to screening
• Exposure to treatment relating to the Class I risk of QT-interval prolongation; exposure to treatment relating to the Class II risk of QT-interval prolongation is allowed if the patient have received not less than 5 half-life periods of flat-dosed treatment