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)

Avionco LLC2 sites in 1 country17 target enrollmentJune 30, 2014

ConditionsMetastatic Castration-Resistant Prostate Cancer (mCRPC)

InterventionsONC1-0013B

DrugsONC1-0013B

Overview

Phase: Phase 1
Intervention: ONC1-0013B
Conditions: Metastatic Castration-Resistant Prostate Cancer (mCRPC)
Sponsor: Avionco LLC
Enrollment: 17
Locations: 2
Primary Endpoint: DLT within 4 weeks of ONC1-0013B administration (safety and tolerability)
Status: Completed
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

June 30, 2014

End Date

April 2017

Last Updated

8 years ago

Study Type

Interventional

Study Design

Single Group

Sex

Male

Investigators

Sponsor

Avionco LLC

Responsible Party

Sponsor

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