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

NCT03074032 | Completed Phase 1 DMC

• 1 other identifier: ONC-ONC10013B-01
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 2

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.

Conditions

Metastatic Castration-Resistant Prostate Cancer (mCRPC)

Outcome Measures

Primary Outcomes (1)

• DLT within 4 weeks of ONC1-0013B administration (safety and tolerability)

  Incidence rate and severity of adverse events, changes in laboratory tests

  4 weeks and during the study up to 76 weeks

Secondary Outcomes (6)

• Peak Plasma Concentration (Cmax)

  28 days

• Area under the plasma concentration versus time curve (AUC)

  28 days

• Elimination half-life (T1/2)

  28 days

• Time-to-peak concentration (tmax)

  28 days

• Steady-State Concentration (Css)

  28 days

Study Arms (4)

ONC1-0013B 40 mg

EXPERIMENTAL

ONC1-0013B 40 mg per os daily

Drug: ONC1-0013B

ONC1-0013B 80 mg

EXPERIMENTAL

ONC1-0013B 80 mg per os daily

Drug: ONC1-0013B

ONC1-0013B 160 mg

EXPERIMENTAL

ONC1-0013B 160 mg per os daily

Drug: ONC1-0013B

ONC1-0013B 320 mg

EXPERIMENTAL

ONC1-0013B 320 mg per os daily

Drug: ONC1-0013B

Interventions

ONC1-0013B DRUG

ONC1-0013B per os daily

ONC1-0013B 160 mg; ONC1-0013B 320 mg; ONC1-0013B 40 mg; ONC1-0013B 80 mg

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Avionco LLC: lead

Study Sites (2)

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, 105426, Russia

Location

Medical Radiological Research Center n.a. A.F. Tsyb (branch of FSBI NMRRC of the Ministry of Health of the Russian Federation)

Obninsk, 249036, Russia

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Single Group Assignment

Study Record Dates

• First Submitted: March 3, 2017
• First Posted: March 8, 2017
• Study Start: June 30, 2014
• Primary Completion: April 1, 2017
• Study Completion: April 1, 2017
• Last Updated: July 11, 2017

Record last verified: 2017-07

Data Sharing

• IPD Sharing: Will not share

Locations

RU (2)