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NCT Number: NCT01284920

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

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

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Key information

Conditions

Prostate Cancer Castration Resistant Prostate Cancer (CRPC) Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostate Neoplasms Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

20 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Chugoku, Japan

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MDV3100

Drug

oral

Primary outcomes

  1. 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.

  2. 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 outcomes

  1. Prostate Specific Antigen (PSA) Response

    Time frame: Day 85 and end of long term dosing period

  2. 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.

Sponsors and collaborators

Lead sponsor

Astellas Pharma Inc

Industry

Collaborators

  • Medivation LLC, a wholly owned subsidiary of Pfizer Inc.

Registry information

Official study title

A Phase I/II, Open-Label, Uncontrolled, Dose-Escalation Study of MDV3100 in Patients With Castration-Resistant Prostate Cancer

Important dates

Study start
2010
Primary completion
2012
Study completion
2014
First posted
Jan 27, 2011
Registry last updated
Nov 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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