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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
January 18, 2011
January 27, 2011
February 1, 2016
November 2010
July 2012   (Final data collection date for primary outcome measure)
  • 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
Same as current
Complete list of historical versions of study NCT01284920 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Not Provided
Not Provided
 
A Study of MDV3100 to Evaluate Safety, Tolerability, Pharmacokinetics and Efficacy of in Prostate Cancer Patients
A Phase I/II, Open-Label, Uncontrolled, Dose-Escalation Study of MDV3100 in Patients With Castration-Resistant Prostate Cancer
This study is to evaluate safety, tolerability pharmacokinetics and efficacy of MDV3100 after oral administration to patients with castration-resistant prostate cancer.
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.
Interventional
Phase 1
Phase 2
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Prostate Neoplasms
  • Prostate Cancer
  • Castration Resistant Prostate Cancer (CRPC)
Drug: MDV3100
oral
  • Experimental: dose-escalation cohort-1
    MDV3100 low dose arm
    Intervention: Drug: MDV3100
  • Experimental: dose-escalation cohort-2
    MDV3100 middle dose arm
    Intervention: Drug: MDV3100
  • Experimental: dose-escalation cohort-3
    MDV3100 high dose arm
    Intervention: Drug: MDV3100
  • Experimental: dose-expansion cohort
    dose expansion with MDV3100 middle dose
    Intervention: Drug: MDV3100
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
47
July 2014
July 2012   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Male
20 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
 
NCT01284920
9785-CL-0111
Yes
Not Provided
Plan to Share IPD: Undecided
Astellas Pharma Inc
Astellas Pharma Inc
Not Provided
Study Chair: Use Central Contact Astellas Pharma Inc
Astellas Pharma Inc
January 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP