Safety, Tolerability and Pharmacokinetics of ONC1-0013B in Patients With Progressive Metastatic Castration-resistant Prostate Cancer
- Conditions
- Metastatic Castration-Resistant Prostate Cancer (mCRPC)
- Interventions
- Registration Number
- NCT03074032
- Lead Sponsor
- Avionco LLC
- Brief Summary
This is a PhaseI, open-label study, Dose-Escalation Study, where tolerated doses will be escalated to the next doses with the safety, tolerability, and PK being evaluated in metastatic castration-resistant prostate cancer (mCRPC) patients. Tumor assessment and PSA values will be evaluated during the study as an additional point.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 17
- 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
-
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description ONC1-0013B 160 mg ONC1-0013B ONC1-0013B 160 mg per os daily ONC1-0013B 80 mg ONC1-0013B ONC1-0013B 80 mg per os daily ONC1-0013B 320 mg ONC1-0013B ONC1-0013B 320 mg per os daily ONC1-0013B 40 mg ONC1-0013B ONC1-0013B 40 mg per os daily
- Primary Outcome Measures
Name Time Method DLT within 4 weeks of ONC1-0013B administration (safety and tolerability) 4 weeks and during the study up to 76 weeks Incidence rate and severity of adverse events, changes in laboratory tests
- Secondary Outcome Measures
Name Time Method Area under the plasma concentration versus time curve (AUC) 28 days PK analysis of ONC1-0013B after single and multiple dosage
Elimination half-life (T1/2) 28 days PK analysis of ONC1-0013B after single and multiple dosage
Time-to-peak concentration (tmax) 28 days PK analysis of ONC1-0013B after single and multiple dosage
Tumor response 12 weeks and during the study up to 76 weeks RECIST 1.1 criteria and the change of the PSA level
Steady-State Concentration (Css) 28 days PK analysis of ONC1-0013B after single and multiple dosage
Peak Plasma Concentration (Cmax) 28 days PK analysis of ONC1-0013B after single and multiple dosage
Trial Locations
- Locations (2)
Medical Radiological Research Center n.a. A.F. Tsyb (branch of FSBI NMRRC of the Ministry of Health of the Russian Federation)
🇷🇺Obninsk, Russian Federation
Research Institute of Urology and Interventional Radiology n.a. N.A. Lopatkin (branch of FSBI NMRRC of the Ministry of Health of the Russian Federation)
🇷🇺Moscow, Russian Federation