NCT02344017

Brief Summary

The purpose of this first-in-man study is to evaluate safety, tolerability and pharmacokinetics of ODM-204 in patients with metastatic castration-resistant prostate cancer.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
23

participants targeted

Target at P25-P50 for phase_1 prostate-cancer

Timeline
Completed

Started Feb 2015

Typical duration for phase_1 prostate-cancer

Geographic Reach
4 countries

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 29, 2014

Completed
24 days until next milestone

First Posted

Study publicly available on registry

January 22, 2015

Completed
10 days until next milestone

Study Start

First participant enrolled

February 1, 2015

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2019

Completed
Last Updated

December 19, 2019

Status Verified

December 1, 2019

Enrollment Period

3.9 years

First QC Date

December 29, 2014

Last Update Submit

December 17, 2019

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (3)

  • Safety and tolerability assessed by incidence of adverse events

    Until disease progression, an expected average of 6 months

  • Safety and tolerability assessed by vitals signs and 12-lead ECG

    Until disease progression, an expected average of 6 months

  • Safety and tolerability assessed by laboratory assessments

    Until disease progression, an expected average of 6 months

Secondary Outcomes (6)

  • Pharmacokinetic profile assessed by plasma peak concentration (Cmax)

    0 - week 12

  • Pharmacokinetic profile assessed by area under the concentration-time curve (AUC)

    0 - week 12

  • Pharmacokinetic profile assessed by time to reach peak concentration (tmax)

    0 - week 12

  • Preliminary antitumour activity assessed by prostate specific antigen (PSA) response

    Until disease progression, an expected average of 6 months

  • Preliminary antitumour activity assessed by response in soft and bone tissues

    Until disease progression, an expected average of 6 months

  • +1 more secondary outcomes

Study Arms (2)

ODM-204 Phase I dose escalation

EXPERIMENTAL

Dose escalation

Drug: ODM-204Drug: Prednisone

ODM-204 Phase II dose expansion

EXPERIMENTAL
Drug: ODM-204Drug: Prednisone

Interventions

ODM-204DRUG

co-administered with prednisone, orally daily

ODM-204 Phase I dose escalationODM-204 Phase II dose expansion
PrednisoneDRUG

ODM-204 is co-administered with oral prednisone

ODM-204 Phase I dose escalationODM-204 Phase II dose expansion

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Written informed consent (IC) obtained.
  • Male aged ≥ 18 years.
  • Histologically or cytologically confirmed adenocarcinoma of prostate.
  • Ongoing GnRH agonist or antagonist therapy, or after bilateral orchiectomy.
  • Progressive metastatic disease
  • Adequate bone marrow, hepatic, and renal function
  • Acceptable and regular bowel movements without any GI disorder or procedure which may interfere with absorption of study treatment
  • Ability to swallow study treatments

You may not qualify if:

  • History of pituitary or adrenal dysfunction.
  • Known brain metastases.
  • Active infection or other medical condition that would make prednisone (corticosteroid) contraindicated.
  • Uncontrolled hypertension
  • Clinically significant heart disease
  • Prolonged QTc interval

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Helsinki University Central Hospital

Helsinki, Finland

Location

Institut Gustave Roussy

Villejuif, France

Location

P. Stradins Clinical University Hospital

Riga, Latvia

Location

Velindre Cancer Centre

Cardiff, United Kingdom

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

ODM-204Prednisone

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

PregnadienediolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • Karim Fizazi

    Gustave Roussy, Cancer Campus, Grand Paris

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

December 29, 2014

First Posted

January 22, 2015

Study Start

February 1, 2015

Primary Completion

January 1, 2019

Study Completion

January 1, 2019

Last Updated

December 19, 2019

Record last verified: 2019-12

Locations

FI(1)GB(1)FR(1)LA(1)