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

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

Detailed Description
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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.

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

Conditions
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Prostate Cancer, Prostate Neoplasms, Castration Resistant Prostate Cancer (CRPC)

Intervention / Treatment
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* Drug: MDV3100


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: dose-escalation cohort-1<br>MDV3100 low dose arm | Drug: MDV3100<br>* oral<br>|
| Experimental: dose-escalation cohort-2<br>MDV3100 middle dose arm | Drug: MDV3100<br>* oral<br>|
| Experimental: dose-escalation cohort-3<br>MDV3100 high dose arm | Drug: MDV3100<br>* oral<br>|
| Experimental: dose-expansion cohort<br>dose expansion with MDV3100 middle dose | Drug: MDV3100<br>* oral<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety assessed by the vital signs, incidence of adverse events, labo-tests and 12-lead EGC | This measure will be assessed on the dose escalation cohorts. | 3 months during the study | 
| Tumor response assessed by Response Evaluation Criteria in Solid Tumors (RECIST) | This measure will be assessed on the dose expansion cohort | Day 85 and end of long term dosing period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prostate Specific Antigen (PSA) Response |  | 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 | This measure will be assessed on the dose expansion cohort. | 3 months during the study | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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docetaxel, Response Evaluation Criteria in Solid Tumor (RECIST), PSA level, MDV3100