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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 01, 2014