Clinical Trials Register

Summary
EudraCT Number:	2010-020821-41
Sponsor's Protocol Code Number:	MDV3100-03
National Competent Authority:	Austria - BASG
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2010-11-03
Trial results	View results

Index
A. PROTOCOL INFORMATION
B. SPONSOR INFORMATION
C. APPLICANT IDENTIFICATION
D. IMP IDENTIFICATION
D.8 INFORMATION ON PLACEBO
E. GENERAL INFORMATION ON THE TRIAL
F. POPULATION OF TRIAL SUBJECTS
G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
P. END OF TRIAL

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A. Protocol Information

A.1

Member State Concerned

Austria - BASG

A.2

EudraCT number

2010-020821-41

A.3

Full title of the trial

PREVAIL: A Multinational Phase 3, Randomized, Double-Blind, Placebo-Controlled Efficacy and Safety Study of Oral MDV3100 in Chemotherapy-Naïve Patients with Progressive Metastatic Prostate Cancer Who Have Failed Androgen Deprivation Therapy

A.3.1

Title of the trial for lay people, in easily understood, i.e. non-technical, language

An International Study to Evaluate the Safety and Effectiveness of
MDV3100 in Patients with Prostate Cancer Where Their Cancer Has
Progressed Despite Hormonal Therapy

A.3.2

Name or abbreviated title of the trial where available

PREVAIL

A.4.1

Sponsor's protocol code number

MDV3100-03

A.5.2

US NCT (ClinicalTrials.gov registry) number

NCT01212991

A.7

Trial is part of a Paediatric Investigation Plan

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	Medivation, Inc., a wholly owned subsidiary of Pfizer Inc.
B.1.3.4	Country	United States
B.3.1 and B.3.2	Status of the sponsor	Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	Medivation Inc.
B.4.2	Country	United States
B.4.1	Name of organisation providing support	Astellas Pharma US Inc.
B.4.2	Country	United States
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Medivation Inc
B.5.2	Functional name of contact point	Medical Officer
B.5.3	Address:
B.5.3.1	Street Address	525 Market Street, 36th Floor
B.5.3.2	Town/ city	San Francisco, CA
B.5.3.3	Post code	94105
B.5.3.4	Country	United States
B.5.4	Telephone number	1415543 3470
B.5.5	Fax number	1415875 7967
B.5.6	E-mail	info@prevailtrial.com

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	Xtandi
D.2.1.1.2	Name of the Marketing Authorisation holder	Astellas Pharma BV
D.2.1.2	Country which granted the Marketing Authorisation	European Union
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	MDV3100
D.3.2	Product code	MDV3100
D.3.4	Pharmaceutical form	Capsule, soft
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Enzalutamide
D.3.9.1	CAS number	915087-33-1
D.3.9.2	Current sponsor code	MDV3100
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	40
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No

D.8 Information on Placebo
D.8 Placebo: 1
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Capsule, soft
D.8.4	Route of administration of the placebo	Oral use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Chemotherapy-Naïve Patients with Progressive Metastatic Prostate Cancer Who Have Failed Androgen Deprivation Therapy

E.1.1.1

Medical condition in easily understood language

Prostate Cancer

E.1.1.2

Therapeutic area

Diseases [C] - Cancer [C04]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	20.0
E.1.2	Level	PT
E.1.2	Classification code	10036909
E.1.2	Term	Prostate cancer metastatic
E.1.2	System Organ Class	10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

Co-Primary Objectives:
• To determine the benefit of MDV3100 as compared to placebo as assessed by overall survival

• To determine the benefit of MDV3100 as compared to placebo as assessed by radiographic progression-free survival (rPFS)

E.2.2

Secondary objectives of the trial

Key Secondary Objectives:
• To determine the benefit of MDV3100 as compared to placebo as assessed by time to first skeletal-related event
• To determine the benefit of MDV3100 as compared to placebo as assessed by time to initiation of cytotoxic chemotherapy

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

The inclusion criteria apply to patients receiving enzalutamide or placebo during double-blind treatment.
Eligible patients must meet all inclusion criteria.
1. Received randomized double-blind treatment in PREVAIL;
2. Open-label day 1 visit is within 6 months after this amendment is approved and becomes effective at the study site;
3. Is willing to maintain androgen deprivation therapy with a gonadotropin-releasing hormone (GnRH) agonist/antagonist or has had
a bilateral orchiectomy;
4. Is able to swallow enzalutamide capsules whole and to comply with study requirements throughout the study;

E.4

Principal exclusion criteria

The exclusion criteria apply only to patients starting new treatment with enzalutamide after receiving placebo as randomized treatment. Each
patient must NOT meet any of the following criteria:
1. Is taking commercially available enzalutamide (Xtandi);
2. Has any clinically significant cardiovascular, dermatologic, endocrine, gastrointestinal, hematologic, hepatic, infectious, metabolic, neurologic,
psychological, pulmonary, or renal disorder or any other condition, including excessive alcohol or drug abuse, or secondary malignancy, that may interfere with study participation in the opinion of the investigator or medical monitor;
3. Has current or previously treated brain metastasis or active leptomeningeal disease;
4. Has a history of seizure or a condition that may increase the risk of seizure;
5. Has total bilirubin ≥ 1.5-times the upper limit of normal (ULN) (except patients with a diagnosis of Gilbert's disease); alanine aminotransferase
(ALT) or aspartate aminotransferase (AST) ≥ 2.5-times ULN at screening. For patients with documented liver metastases, ALT and AST exclusion is > 5-times ULN;
6. Has creatinine > 2 mg/dL (177 μmol/L) at screening.

E.5 End points

E.5.1

Primary end point(s)

Co-primary endpoints:
Overall Survival and Radiographic Progression Free Survival

E.5.1.1

Timepoint(s) of evaluation of this end point

Overall Survival: Time from randomization to death due to any cause will be assessed

Radiographic Progression-Free Survival: Time from randomization to the first objective evidence of radiologic progression or death due to any cause (whichever occurs first) will be assessed

E.5.2

Secondary end point(s)

Time to First Skeletal-Related Event
Time to Initiation of Cytotoxic Chemotherapy

E.5.2.1

Timepoint(s) of evaluation of this end point

Time to First Skeletal-Related Event: Time from randomization to first skeletal-related event will be assessed

Time to Initiation of Cytotoxic Chemotherapy: Time from randomization to initiation of cytotoxic chemotherapy will be assessed

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

E.6.3

Therapy

Yes

E.6.4

Safety

Yes

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

Yes

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

Yes

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

Yes

E.6.13.1

Other scope of the trial description

Quality of Life

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

E.7.3

Therapeutic confirmatory (Phase III)

Yes

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

Yes

E.8.1.1

Randomised

Yes

E.8.1.2

Open

E.8.1.3

Single blind

E.8.1.4

Double blind

Yes

E.8.1.5

Parallel group

Yes

E.8.1.6

Cross over

E.8.1.7

Other

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

E.8.2.2

Placebo

Yes

E.8.2.3

Other

E.8.2.4

Number of treatment arms in the trial

E.8.3

The trial involves single site in the Member State concerned

E.8.4

The trial involves multiple sites in the Member State concerned

Yes

E.8.4.1

Number of sites anticipated in Member State concerned

E.8.5

The trial involves multiple Member States

Yes

E.8.5.1

Number of sites anticipated in the EEA

150

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

Yes

E.8.6.2

Trial being conducted completely outside of the EEA

E.8.6.3

If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned

Australia

Austria

Belgium

Canada

Denmark

Finland

France

Germany

Israel

Italy

Japan

Korea, Republic of

Lithuania

Netherlands

Poland

Russian Federation

Singapore

Slovakia

Spain

Sweden

United Kingdom

United States

E.8.7

Trial has a data monitoring committee

Yes

E.8.8

Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial

LVLS

E.8.9 Initial estimate of the duration of the trial

E.8.9.1

In the Member State concerned years

E.8.9.1

In the Member State concerned months

E.8.9.1

In the Member State concerned days

E.8.9.2

In all countries concerned by the trial years

E.8.9.2

In all countries concerned by the trial months

E.8.9.2

In all countries concerned by the trial days

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

F.1.1

Number of subjects for this age range:

F.1.1.1

In Utero