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

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01284920
• Other study ID #: 9785-CL-0111
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: November 2, 2010
• Est. completion date: July 2, 2014

Study information

• Verified date: November 2018
• Source: Astellas Pharma Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 47
• Est. completion date: July 2, 2014
• Est. primary completion date: July 12, 2012
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Castration Resistant Prostate Cancer (CRPC)
• Prostate Cancer
• Prostate Neoplasms
• Prostatic Neoplasms

Intervention

Drug:
• MDV3100
oral

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Astellas Pharma Inc	Medivation LLC, a wholly owned subsidiary of Pfizer Inc.

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Prostate Specific Antigen (PSA) Response		Day 85 and end of long term dosing period
Secondary	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

External Links

•   Link to results on the Astellas Clinical Study Results website