NCT01284920

Brief Summary

This study is to evaluate safety, tolerability pharmacokinetics and efficacy of MDV3100 after oral administration to patients with castration-resistant prostate cancer.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
47

participants targeted

Target at P50-P75 for phase_1 prostate-cancer

Timeline
Completed

Started Nov 2010

Geographic Reach
1 country

7 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

Study Start

First participant enrolled

November 2, 2010

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 18, 2011

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 27, 2011

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 12, 2012

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 2, 2014

Completed
Last Updated

November 21, 2024

Status Verified

November 1, 2024

Enrollment Period

1.7 years

First QC Date

January 18, 2011

Last Update Submit

November 19, 2024

Conditions

Prostate CancerProstate NeoplasmsCastration Resistant Prostate Cancer (CRPC)

Keywords

docetaxelResponse Evaluation Criteria in Solid Tumor (RECIST)PSA levelMDV3100

Outcome Measures

Primary Outcomes (2)

  • Safety assessed by the vital signs, incidence of adverse events, labo-tests and 12-lead EGC

    This measure will be assessed on the dose escalation cohorts.

    3 months during the study

  • Tumor response assessed by Response Evaluation Criteria in Solid Tumors (RECIST)

    This measure will be assessed on the dose expansion cohort

    Day 85 and end of long term dosing period

Secondary Outcomes (2)

  • Prostate Specific Antigen (PSA) Response

    Day 85 and end of long term dosing period

  • Safety assessed by the vital signs, incidence of adverse events, labo-tests and 12-lead ECG

    3 months during the study

Study Arms (4)

dose-escalation cohort-1

EXPERIMENTAL

MDV3100 low dose arm

Drug: MDV3100

dose-escalation cohort-2

EXPERIMENTAL

MDV3100 middle dose arm

Drug: MDV3100

dose-escalation cohort-3

EXPERIMENTAL

MDV3100 high dose arm

Drug: MDV3100

dose-expansion cohort

EXPERIMENTAL

dose expansion with MDV3100 middle dose

Drug: MDV3100

Interventions

MDV3100DRUG

oral

dose-escalation cohort-1dose-escalation cohort-2dose-escalation cohort-3dose-expansion cohort

Eligibility Criteria

Age20 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histologically or cytologically confirmed adenocarcinoma of the prostate
  • Ongoing androgen deprivation therapy with a GnRH analogue or a bilateral orchiectomy
  • Progressive disease after prior androgen deprivation therapy (medical or surgical castration)
  • For Expansion Cohort, the patient has no more than two prior chemotherapy regimens with at least one regimen containing docetaxel
  • For Expansion Cohort, the patient must have measurable lesions by RECIST

You may not qualify if:

  • Metastases in the brain
  • History of another malignancy except for adenocarcinoma of the prostate within the previous 5 years
  • Use of bicalutamide within 6 weeks prior to study
  • Radiation therapy within 12 weeks prior to study
  • Evidence of serious drug hypersensitivity

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Unknown Facility

Chugoku, Japan

Location

Unknown Facility

Chūbu, Japan

Location

Unknown Facility

Hokkaido, Japan

Location

Unknown Facility

Kansai, Japan

Location

Unknown Facility

Kanto, Japan

Location

Unknown Facility

Kyusyu, Japan

Location

Unknown Facility

Shikoku, Japan

Location

Related Publications (1)

  • Akaza H, Uemura H, Tsukamoto T, Ozono S, Ogawa O, Sakai H, Oya M, Namiki M, Fukasawa S, Yamaguchi A, Uemura H, Ohashi Y, Maeda H, Saito A, Takeda K, Naito S. A multicenter phase I/II study of enzalutamide in Japanese patients with castration-resistant prostate cancer. Int J Clin Oncol. 2016 Aug;21(4):773-782. doi: 10.1007/s10147-016-0952-6. Epub 2016 Jan 21.

    PMID: 26793974DERIVED

Related Links

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

enzalutamide

Condition Hierarchy (Ancestors)

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

Study Officials

  • Use Central Contact

    Astellas Pharma Inc

    STUDY CHAIR

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

Study Record Dates

First Submitted

January 18, 2011

First Posted

January 27, 2011

Study Start

November 2, 2010

Primary Completion

July 12, 2012

Study Completion

July 2, 2014

Last Updated

November 21, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

Access to anonymized individual participant level data will not be provided for this trial. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.

Locations

JP(7)