History of Changes for Study: NCT00974311

Safety and Efficacy Study of MDV3100 in Patients With Castration-Resistant Prostate Cancer Who Have Been Previously Treated With Docetaxel-based Chemotherapy (AFFIRM)

Latest version (submitted November 15, 2018) on ClinicalTrials.gov

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Study Record Versions

Version	Submitted Date	Changes
1	September 9, 2009	None (earliest Version on record)
2	September 10, 2009	Contacts/Locations and Study Status
3	September 14, 2009	Contacts/Locations and Study Status
4	October 6, 2009	Study Status and Contacts/Locations
5	October 22, 2009	Contacts/Locations and Study Status
6	November 4, 2009	Study Status and Contacts/Locations
7	November 18, 2009	Contacts/Locations and Study Status
8	December 15, 2009	Study Status and Contacts/Locations
9	January 11, 2010	Study Status and Contacts/Locations
10	January 20, 2010	Contacts/Locations and Study Status
11	February 3, 2010	Study Status and Contacts/Locations
12	February 9, 2010	Contacts/Locations and Study Status
13	February 23, 2010	Contacts/Locations and Study Status
14	March 10, 2010	Study Status and Contacts/Locations
15	April 22, 2010	Study Status and Contacts/Locations
16	April 29, 2010	Contacts/Locations and Study Status
17	September 22, 2010	Contacts/Locations and Study Status
18	November 17, 2010	Recruitment Status, Study Status and Contacts/Locations
19	May 9, 2012	Study Status and Sponsor/Collaborators
20	July 10, 2012	Eligibility, Outcome Measures, Study Design, Study Status, Arms and Interventions, Oversight and Sponsor/Collaborators
21	September 28, 2012	Outcome Measures, Arms and Interventions, Study Status and Results
22	November 2, 2012	Study Status and Contacts/Locations
23	November 15, 2012	Outcome Measures and Study Status
24	February 22, 2014	Study Status and Baseline Characteristics
25	December 4, 2017	Outcome Measures, Contacts/Locations, Study Status, More Information, Study Identification, Sponsor/Collaborators, Baseline Characteristics, Participant Flow, Eligibility, Adverse Events, Arms and Interventions and Conditions
26	March 14, 2018	Recruitment Status, Study Status and Sponsor/Collaborators
27	April 19, 2018	Sponsor/Collaborators and Study Status
28	June 6, 2018	Study Status and Contacts/Locations
29	July 18, 2018	Study Status
30	October 4, 2018	Study Status and Contacts/Locations
31	November 15, 2018	Adverse Events, Participant Flow, Outcome Measures, Baseline Characteristics, More Information, Sponsor/Collaborators and Study Status

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Merged
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Study NCT00974311
Submitted Date: September 9, 2009 (v1)

Study Identification


Unique Protocol ID:	CRPC2
Brief Title:	Safety and Efficacy Study of MDV3100 in Patients With Castration-Resistant Prostate Cancer Who Have Been Previously Treated With Docetaxel-based Chemotherapy (AFFIRM)
Official Title:	AFFIRM: A Multinational Phase 3, Randomized, Double-Blind, Placebo-COntrolled Efficacy and Safety Study of Oral MDV3100 in Patients With Progressive Castration-Resistant Prostate Cancer Previously Treated With Docetaxel-Based Chemotherapy
Secondary IDs:

Study Status


Record Verification:	September 2009
Overall Status:	Recruiting
Study Start:
Primary Completion:
Study Completion:

First Submitted:	September 9, 2009
First Submitted that Met QC Criteria:	September 9, 2009
First Posted:	September 10, 2009 [Estimate]

Last Update Submitted that Met QC Criteria:	September 9, 2009
Last Update Posted:	September 10, 2009 [Estimate]

Study Description


Brief Summary:	This is a phase 3 study to compare the clinical benefit of MDV3100 versus placebo in patients with castration-resistant prostate cancer who have been previously treated with docetaxel-based chemotherapy.
Detailed Description:

Conditions


Conditions:	Castration-Resistant Prostate Cancer
Keywords:	MDV3100 Prostate Cancer Castration-resistant

Study Design


Study Type:	Interventional
Primary Purpose:	Other
Study Phase:	Phase 3
Interventional Study Model:
Number of Arms:	2
Masking:	(masked roles unspecified)
Enrollment:

Arms and Interventions

Arms	Assigned Interventions
Experimental: MDV3100	Drug: MDV3100 MDV3100, 160 mg orally per day
Placebo Comparator: Placebo	Drug: Placebo

Eligibility


Minimum Age:
Maximum Age:
Sex:	Male
Gender Based:
Accepts Healthy Volunteers:	No
Criteria:	Inclusion Criteria: Progressive prostate cancer Medical or surgical castration with testosterone less than 50 ng/dl One or two prior chemotherapy regimens. At least one chemotherapy regimen must have contained docetaxel ECOG performance status 0-2 Adequate bone marrow, hepatic, and renal function Able to swallow the study drug and comply with study requirements Informed consent Exclusion Criteria: Metastases in the brain or active epidural disease Another malignancy within the previous 5 years Clinically significant cardiovascular disease GI disorder affecting absorption

Contacts/Locations


Central Contact Person:	Mohammad Hirmand, MD Telephone: 415-543-3470
Locations:	United States, Nevada
	[Recruiting] Las Vegas, Nevada, United States, 89169

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