Clincosm LogoSign in Get a demo

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

Sponsor
Avionco LLC (Industry)
Overall Status
Completed
CT.gov ID
NCT03074032
Collaborator
(none)
17
Enrollment
2
Locations
4
Arms
33.1
Actual Duration (Months)
8.5
Patients Per Site
0.3
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
17 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Intervention Model Description:
Single Group AssignmentSingle Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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)
Actual Study Start Date :
Jun 30, 2014
Actual Primary Completion Date :
Apr 1, 2017
Actual Study Completion Date :
Apr 1, 2017

Arms and Interventions

Arm Intervention/Treatment
Experimental: ONC1-0013B 40 mg

ONC1-0013B 40 mg per os daily

Drug: ONC1-0013B
ONC1-0013B per os daily
Experimental: ONC1-0013B 80 mg

ONC1-0013B 80 mg per os daily

Drug: ONC1-0013B
ONC1-0013B per os daily
Experimental: ONC1-0013B 160 mg

ONC1-0013B 160 mg per os daily

Drug: ONC1-0013B
ONC1-0013B per os daily
Experimental: ONC1-0013B 320 mg

ONC1-0013B 320 mg per os daily

Drug: ONC1-0013B
ONC1-0013B per os daily

Outcome Measures

Primary Outcome Measures

  1. 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

  1. Peak Plasma Concentration (Cmax) [28 days]

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

  2. Area under the plasma concentration versus time curve (AUC) [28 days]

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

  3. Elimination half-life (T1/2) [28 days]

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

  4. Time-to-peak concentration (tmax) [28 days]

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

  5. Steady-State Concentration (Css) [28 days]

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

  6. Tumor response [12 weeks and during the study up to 76 weeks]

    RECIST 1.1 criteria and the change of the PSA level

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Male
Accepts 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

  1. Clinically significant cardiovascular system diseases:

  2. Clinically significant central nervous system diseases:

  3. History of other significant concomitant diseases which, in the Investigator's opinion, may cause a disease recurrence (i.e. uncontrolled diabetes mellitus)

  4. 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 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 105426
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 249036

Sponsors and Collaborators

  • Avionco LLC

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Avionco LLC
ClinicalTrials.gov Identifier:
NCT03074032
Other Study ID Numbers:
  • ONC-ONC10013B-01
First Posted:
Mar 8, 2017
Last Update Posted:
Jul 11, 2017
Last Verified:
Jul 1, 2017
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Prostatic Neoplasms

Study Results

No Results Posted as of Jul 11, 2017