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

Primary Purpose

Metastatic Castration-Resistant Prostate Cancer (mCRPC)

Status

Completed

Phase

Phase 1

Locations

Russian Federation

Study Type

Interventional

Intervention

ONC1-0013B

About this trial

This is an interventional treatment trial for Metastatic Castration-Resistant Prostate Cancer (mCRPC)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Arm Label

ONC1-0013B 40 mg

ONC1-0013B 80 mg

ONC1-0013B 160 mg

ONC1-0013B 320 mg

Arm Description

ONC1-0013B 40 mg per os daily

ONC1-0013B 80 mg per os daily

ONC1-0013B 160 mg per os daily

ONC1-0013B 320 mg per os daily

Outcomes

Primary Outcome Measures

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

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

Secondary Outcome Measures

Peak Plasma Concentration (Cmax)

PK analysis of ONC1-0013B after single and multiple dosage

Area under the plasma concentration versus time curve (AUC)

PK analysis of ONC1-0013B after single and multiple dosage

Elimination half-life (T1/2)

PK analysis of ONC1-0013B after single and multiple dosage

Time-to-peak concentration (tmax)

PK analysis of ONC1-0013B after single and multiple dosage

Steady-State Concentration (Css)

PK analysis of ONC1-0013B after single and multiple dosage

Tumor response

RECIST 1.1 criteria and the change of the PSA level

Full Information

NCT ID

NCT03074032

First Posted

March 3, 2017

Last Updated

July 8, 2017

Sponsor

Avionco LLC

1. Study Identification

Unique Protocol Identification Number

NCT03074032

Brief Title

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

Official Title

Phase I Open-label Single- and Multiple-ascending Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of ONC1-0013B in Patients With Progressive Metastatic Castration-resistant Prostate Cancer (mCRPC)

Study Type

Interventional

2. Study Status

Record Verification Date

July 2017

Overall Recruitment Status

Completed

Study Start Date

June 30, 2014 (Actual)

Primary Completion Date

April 2017 (Actual)

Study Completion Date

April 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Avionco LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Metastatic Castration-Resistant Prostate Cancer (mCRPC)

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Model Description

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

17 (Actual)

8. Arms, Groups, and Interventions

Arm Title

ONC1-0013B 40 mg

Arm Type

Experimental

Arm Description

ONC1-0013B 40 mg per os daily

Arm Title

ONC1-0013B 80 mg

Arm Type

Experimental

Arm Description

ONC1-0013B 80 mg per os daily

Arm Title

ONC1-0013B 160 mg

Arm Type

Experimental

Arm Description

ONC1-0013B 160 mg per os daily

Arm Title

ONC1-0013B 320 mg

Arm Type

Experimental

Arm Description

ONC1-0013B 320 mg per os daily

Intervention Type

Drug

Intervention Name(s)

ONC1-0013B

Intervention Description

ONC1-0013B per os daily

Primary Outcome Measure Information:

Title

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

Description

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

Time Frame

4 weeks and during the study up to 76 weeks

Secondary Outcome Measure Information:

Title

Peak Plasma Concentration (Cmax)

Description

PK analysis of ONC1-0013B after single and multiple dosage

Time Frame

28 days

Title

Area under the plasma concentration versus time curve (AUC)

Description

PK analysis of ONC1-0013B after single and multiple dosage

Time Frame

28 days

Title

Elimination half-life (T1/2)

Description

PK analysis of ONC1-0013B after single and multiple dosage

Time Frame

28 days

Title

Time-to-peak concentration (tmax)

Description

PK analysis of ONC1-0013B after single and multiple dosage

Time Frame

28 days

Title

Steady-State Concentration (Css)

Description

PK analysis of ONC1-0013B after single and multiple dosage

Time Frame

28 days

Title

Tumor response

Description

RECIST 1.1 criteria and the change of the PSA level

Time Frame

12 weeks and during the study up to 76 weeks

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Facility Information:

Facility Name

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)

City

Moscow

ZIP/Postal Code

105426

Country

Russian Federation

Facility Name

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

City

Obninsk

ZIP/Postal Code

249036

Country

Russian Federation

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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