A Study of MDV3100 to Evaluate Safety, Tolerability, Pharmacokinetics and Efficacy of in Prostate Cancer Patients

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT01284920
First received: January 18, 2011
Last updated: January 10, 2014
Last verified: January 2014
  Purpose

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


Condition Intervention Phase
Prostate Neoplasms
Prostate Cancer
Castration Resistant Prostate Cancer (CRPC)
Drug: MDV3100
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I/II, Open-Label, Uncontrolled, Dose-Escalation Study of MDV3100 in Patients With Castration-Resistant Prostate Cancer

Resource links provided by NLM:


Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:
  • Safety assessed by the vital signs, incidence of adverse events, labo-tests and 12-lead EGC [ Time Frame: 3 months during the study ] [ Designated as safety issue: No ]
    This measure will be assessed on the dose escalation cohorts.

  • Tumor response assessed by Response Evaluation Criteria in Solid Tumors (RECIST) [ Time Frame: Day 85 and end of long term dosing period ] [ Designated as safety issue: No ]
    This measure will be assessed on the dose expansion cohort


Secondary Outcome Measures:
  • Prostate Specific Antigen (PSA) Response [ Time Frame: Day 85 and end of long term dosing period ] [ Designated as safety issue: No ]
  • Safety assessed by the vital signs, incidence of adverse events, labo-tests and 12-lead ECG [ Time Frame: 3 months during the study ] [ Designated as safety issue: No ]
    This measure will be assessed on the dose expansion cohort.


Enrollment: 47
Study Start Date: November 2010
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: dose-escalation cohort-1
MDV3100 low dose arm
Drug: MDV3100
oral
Experimental: dose-escalation cohort-2
MDV3100 middle dose arm
Drug: MDV3100
oral
Experimental: dose-escalation cohort-3
MDV3100 high dose arm
Drug: MDV3100
oral
Experimental: dose-expansion cohort
dose expansion with MDV3100 middle dose
Drug: MDV3100
oral

Detailed Description:

This is a Phase1/2, open-label, uncontrolled study, involving Dose-Escalation Cohorts, where dose will be escalated to next dose with the safety, tolerability, and PK being evaluated in metastatic castration-resistant prostate cancer (mCRPC) patients and an Expansion Cohort, where the efficacy, safety, and PK of MDV3100 in post-chemo mCRPC patients will be evaluated. After evaluation of the safety and tolerability in Dose-Escalation Cohorts, additional patients are included in Expansion Cohort.

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01284920

Locations
Japan
Chubu, Japan
Chugoku, Japan
Hokkaido, Japan
Kansai, Japan
Kanto, Japan
Kyusyu, Japan
Shikoku, Japan
Sponsors and Collaborators
Astellas Pharma Inc
Investigators
Study Chair: Use Central Contact Astellas Pharma Inc
  More Information

No publications provided

Responsible Party: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT01284920     History of Changes
Other Study ID Numbers: 9785-CL-0111
Study First Received: January 18, 2011
Last Updated: January 10, 2014
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by Astellas Pharma Inc:
MDV3100
Response Evaluation Criteria in Solid Tumor (RECIST)
docetaxel
PSA level

Additional relevant MeSH terms:
Neoplasms
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on April 16, 2014