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

Phase 1

Completed

• Conditions: Prostate Cancer; Prostate Neoplasms; Castration Resistant Prostate Cancer (CRPC)
• Interventions: Drug: MDV3100

• Registration Number: NCT01284920
• Lead Sponsor: Astellas Pharma Inc

Brief Summary

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

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.

Study Timeline

• Study Start: 2010-11-02
• Study First Submitted: 2011-01-18
• Study First Submitted QC: 2011-01-26
• Study First Posted: 2011-01-27
• Primary Completion: 2012-07-12
• Study Completion: 2014-07-02
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-19
• Last Update Posted: 2024-11-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 47

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
dose-escalation cohort-3	MDV3100	MDV3100 high dose arm
dose-expansion cohort	MDV3100	dose expansion with MDV3100 middle dose
dose-escalation cohort-1	MDV3100	MDV3100 low dose arm
dose-escalation cohort-2	MDV3100	MDV3100 middle dose arm

Primary Outcome Measures

Name	Time	Method
Safety assessed by the vital signs, incidence of adverse events, labo-tests and 12-lead EGC	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)	Day 85 and end of long term dosing period	This measure will be assessed on the dose expansion cohort

Secondary Outcome Measures

Name	Time	Method
Safety assessed by the vital signs, incidence of adverse events, labo-tests and 12-lead ECG	3 months during the study	This measure will be assessed on the dose expansion cohort.
Prostate Specific Antigen (PSA) Response	Day 85 and end of long term dosing period