Metastatic Castration-Resistant Prostate Cancer (mCRPC)
Conditions
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.
Interventions
DRUGONC1-0013B
ONC1-0013B per os daily
Sponsors
Avionco LLC
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Single Group Assignment
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Men aged 18 years and older. 2. Histologically confirmed diagnosis of prostate cancer 3. Castrate level of testosterone in blood serum \< 1,7 nmol/l or \< 50 ng/dl 4. PSA level at screening \> 2 ng/ml 5. Progression of metastatic CRPC after the chemical castration with gonadotropin-releasing hormone (GnRH) analogue or after the chemical castration and subsequent chemotherapy. 6. The patient's ECOG performance status of 0 - 2 7. Patients previously treated with docetaxel chemotherapy should have received 2 or less prior lines of chemotherapy for mCRPC 8. The expected survival time of not less than 12 weeks
Exclusion criteria
1. 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 2. Clinically significant cardiovascular system diseases: 3. Clinically significant central nervous system diseases: 4. History of other significant concomitant diseases which, in the Investigator's opinion, may cause a disease recurrence (i.e. uncontrolled diabetes mellitus) 5. 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Peak Plasma Concentration (Cmax) | 28 days | PK analysis of ONC1-0013B after single and multiple dosage |
| Steady-State Concentration (Css) | 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 |
| Time-to-peak concentration (tmax) | 28 days | PK analysis of ONC1-0013B after single and multiple dosage |
Countries
Russia
Outcome results
None listed