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

Sponsor:	Astellas Pharma Inc
Information provided by (Responsible Party):	Astellas Pharma Inc
ClinicalTrials.gov Identifier:	NCT01284920

Purpose

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

Condition	Intervention	Phase
Prostate Neoplasms Prostate Cancer Castration Resistant Prostate Cancer (CRPC)	Drug: MDV3100	Phase I Phase II

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: 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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Prostate Cancer

U.S. FDA Resources

Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:

Safety assessed by the vital signs, incidence of adverse events, labo-tests and 12-lead EGC [ Time Frame: 3 months during the study ] [ Designated as safety issue: No ]
This measure will be assessed on the dose escalation cohorts.
Tumor response assessed by Response Evaluation Criteria in Solid Tumors (RECIST) [ Time Frame: Day 85 and end of long term dosing period ] [ Designated as safety issue: No ]
This measure will be assessed on the dose expansion cohort

Secondary Outcome Measures:

Prostate Specific Antigen (PSA) Response [ Time Frame: Day 85 and end of long term dosing period ] [ Designated as safety issue: No ]
Safety assessed by the vital signs, incidence of adverse events, labo-tests and 12-lead ECG [ Time Frame: 3 months during the study ] [ Designated as safety issue: No ]
This measure will be assessed on the dose expansion cohort.

Estimated Enrollment:	46
Study Start Date:	November 2010
Estimated Study Completion Date:	December 2012
Estimated Primary Completion Date:	December 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

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.

Eligibility

Ages Eligible for Study:	20 Years and older
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01284920

Contacts

Contact: Clinical Development Administration Department

clinicaltrials_info@jp.astellas.com

Locations

Japan
	Recruiting
Chubu, Japan
	Recruiting
Chugoku, Japan
	Recruiting
Hokkaido, Japan
	Recruiting
Kansai, Japan
	Recruiting
Kanto, Japan
	Recruiting
Kyusyu, Japan
	Recruiting
Shikoku, Japan

Sponsors and Collaborators

Astellas Pharma Inc

Investigators

Study Chair:

Use Central Contact

Astellas Pharma Inc

More Information

No publications provided

Responsible Party:	Astellas Pharma Inc
ClinicalTrials.gov Identifier:	NCT01284920 History of Changes
Other Study ID Numbers:	9785-CL-0111
Study First Received:	January 18, 2011
Last Updated:	December 15, 2011
Health Authority:	Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by Astellas Pharma Inc:

MDV3100
Response Evaluation Criteria in Solid Tumor (RECIST)
docetaxel
PSA level

Additional relevant MeSH terms:

Neoplasms
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms

Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on February 28, 2012