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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01284920
First Posted: January 27, 2011
Last Update Posted: February 1, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Astellas Pharma Inc
  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
Intervention Model: Single Group Assignment
Masking: None (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 ]
    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 ]
    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 ]
  • Safety assessed by the vital signs, incidence of adverse events, labo-tests and 12-lead ECG [ Time Frame: 3 months during the study ]
    This measure will be assessed on the dose expansion cohort.


Enrollment: 47
Study Start Date: November 2010
Study Completion Date: July 2014
Primary Completion Date: July 2012 (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

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT01284920     History of Changes
Other Study ID Numbers: 9785-CL-0111
First Submitted: January 18, 2011
First Posted: January 27, 2011
Last Update Posted: February 1, 2016
Last Verified: January 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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

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