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

Sponsor

Astellas Pharma Inc (Industry)

Overall Status

Completed

CT.gov ID

NCT01284920

Collaborator

Medivation LLC, a wholly owned subsidiary of Pfizer Inc. (Industry)

Enrollment

Locations

Arms

Actual Duration (Months)

6.7

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Prostate Cancer Prostate Neoplasms Castration Resistant Prostate Cancer (CRPC)	Drug: MDV3100	Phase 1/Phase 2

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 Design

Study Type:

Interventional

Actual Enrollment :

47 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (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

Actual Study Start Date :

Nov 2, 2010

Actual Primary Completion Date :

Jul 12, 2012

Actual Study Completion Date :

Jul 2, 2014

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

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

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 [3 months during the study]
This measure will be assessed on the dose expansion cohort.

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years and Older

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

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