Safety and Efficacy Study of MDV3100 in Patients With Castration-Resistant Prostate Cancer Who Have Been Previously Treated With Docetaxel-based Chemotherapy (AFFIRM)
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00974311 |
Recruitment Status :
Completed
First Posted : September 10, 2009
Results First Posted : October 30, 2012
Last Update Posted : December 11, 2018
|
Sponsor:
Pfizer
Collaborators:
Astellas Pharma Inc
Medivation LLC, a wholly owned subsidiary of Pfizer Inc.
Information provided by (Responsible Party):
Pfizer
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Study Type | Interventional |
---|---|
Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Investigator, Outcomes Assessor); Primary Purpose: Treatment |
Condition |
Castration-Resistant Prostate Cancer |
Interventions |
Drug: Enzalutamide Drug: Placebo |
Enrollment | 1199 |
Participant Flow
Recruitment Details | A total of 1199 participants were enrolled and randomized for double-blind (DB) phase. Out of which, 159 participants entered the optional open-label extension (OLE) phase. |
Pre-assignment Details | Participants were randomized 2:1 to receive either Enzalutamide or Placebo in DB phase. All participants who continued in OLE phase, received Enzalutamide. |
Arm/Group Title | Enzalutamide | Placebo |
---|---|---|
Arm/Group Description | In DB Phase, participants received Enzalutamide capsules 160 mg orally per day. Participants who completed DB Phase, entered in optional OLE Phase and received same treatment until unacceptable toxicity, confirmed disease progression and the participant was scheduled to initiate a new systemic anti-neoplastic therapy, death or withdrawal (median treatment duration was 8.3 months). | In DB Phase, participants received placebo capsules (for Enzalutamide) orally per day. Participants who completed DB Phase, entered in optional OLE Phase and received Enzalutamide capsules 160 mg orally per day until unacceptable toxicity, confirmed disease progression and the participant was scheduled to initiate a new systemic anti-neoplastic therapy, death or withdrawal (median treatment duration was 3.0 months in DB Phase and 7.7 months in OLE Phase). |
Period Title: DB Phase (up to 24 Months) | ||
Started | 800 | 399 |
Completed | 109 | 50 |
Not Completed | 691 | 349 |
Reason Not Completed | ||
Lost to Follow-up | 5 | 2 |
Death | 561 | 298 |
Withdrawal by Subject | 16 | 7 |
Study Terminated by Sponsor | 108 | 42 |
Other | 1 | 0 |
Period Title: OLE Phase (up to 77 Months) | ||
Started | 109 | 50 |
Completed | 0 | 0 |
Not Completed | 109 | 50 |
Reason Not Completed | ||
Death | 14 | 21 |
Study Terminated by Sponsor | 78 | 26 |
Other | 15 | 2 |
Withdrawal by Subject | 2 | 1 |
Baseline Characteristics
Arm/Group Title | Enzalutamide | Placebo | Total | |
---|---|---|---|---|
Arm/Group Description | In DB Phase, participants received Enzalutamide capsules 160 mg orally per day. Participants who completed DB Phase, entered in optional OLE Phase and received same treatment until unacceptable toxicity, confirmed disease progression and the participant was scheduled to initiate a new systemic anti-neoplastic therapy, death or withdrawal (median treatment duration was 8.3 months). | In DB Phase, participants received placebo capsules (for Enzalutamide) orally per day. Participants who completed DB Phase, entered in optional OLE Phase and received Enzalutamide capsules 160 mg orally per day until unacceptable toxicity, confirmed disease progression and the participant was scheduled to initiate a new systemic anti-neoplastic therapy, death or withdrawal (median treatment duration was 3.0 months in DB Phase and 7.7 months in OLE Phase). | Total of all reporting groups | |
Overall Number of Baseline Participants | 800 | 399 | 1199 | |
Baseline Analysis Population Description |
Intent-to-treat population (ITT) included all participants who were randomized into the study.
|
|||
Age, Categorical
Measure Type: Count of Participants Unit of measure: Participants |
||||
Number Analyzed | 800 participants | 399 participants | 1199 participants | |
<=18 years |
0 0.0%
|
0 0.0%
|
0 0.0%
|
|
Between 18 and 65 years |
232 29.0%
|
130 32.6%
|
362 30.2%
|
|
>=65 years |
568 71.0%
|
269 67.4%
|
837 69.8%
|
|
Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
||||
Number Analyzed | 800 participants | 399 participants | 1199 participants | |
68.8 (7.96) | 68.6 (8.39) | 68.7 (8.11) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
||||
Number Analyzed | 800 participants | 399 participants | 1199 participants | |
Female |
0 0.0%
|
0 0.0%
|
0 0.0%
|
|
Male |
800 100.0%
|
399 100.0%
|
1199 100.0%
|
|
Ethnicity (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
||||
Number Analyzed | 800 participants | 399 participants | 1199 participants | |
Hispanic or Latino |
32 4.0%
|
23 5.8%
|
55 4.6%
|
|
Not Hispanic or Latino |
768 96.0%
|
376 94.2%
|
1144 95.4%
|
|
Unknown or Not Reported |
0 0.0%
|
0 0.0%
|
0 0.0%
|
|
Race (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
||||
Number Analyzed | 800 participants | 399 participants | 1199 participants | |
American Indian or Alaska Native |
1 0.1%
|
1 0.3%
|
2 0.2%
|
|
Asian |
5 0.6%
|
8 2.0%
|
13 1.1%
|
|
Native Hawaiian or Other Pacific Islander |
1 0.1%
|
0 0.0%
|
1 0.1%
|
|
Black or African American |
27 3.4%
|
20 5.0%
|
47 3.9%
|
|
White |
745 93.1%
|
366 91.7%
|
1111 92.7%
|
|
More than one race |
0 0.0%
|
0 0.0%
|
0 0.0%
|
|
Unknown or Not Reported |
21 2.6%
|
4 1.0%
|
25 2.1%
|
|
Region of Enrollment
Measure Type: Count of Participants Unit of measure: Participants |
Number Analyzed | 800 participants | 399 participants | 1199 participants |
United States |
181 22.6%
|
107 26.8%
|
288 24.0%
|
|
Spain |
23 2.9%
|
13 3.3%
|
36 3.0%
|
|
Austria |
15 1.9%
|
10 2.5%
|
25 2.1%
|
|
Chile |
6 0.8%
|
5 1.3%
|
11 0.9%
|
|
United Kingdom |
82 10.3%
|
50 12.5%
|
132 11.0%
|
|
Italy |
20 2.5%
|
10 2.5%
|
30 2.5%
|
|
France |
193 24.1%
|
80 20.1%
|
273 22.8%
|
|
Canada |
82 10.3%
|
25 6.3%
|
107 8.9%
|
|
Argentina |
7 0.9%
|
3 0.8%
|
10 0.8%
|
|
Belgium |
27 3.4%
|
18 4.5%
|
45 3.8%
|
|
Poland |
7 0.9%
|
4 1.0%
|
11 0.9%
|
|
Australia |
60 7.5%
|
33 8.3%
|
93 7.8%
|
|
South Africa |
3 0.4%
|
3 0.8%
|
6 0.5%
|
|
Germany |
62 7.8%
|
24 6.0%
|
86 7.2%
|
|
Netherlands |
32 4.0%
|
14 3.5%
|
46 3.8%
|
Outcome Measures
Adverse Events
Limitations and Caveats
The primary objectives (overall survival) of the study had been met and all participants who had remained on study treatment have discontinued and therefore the study has been considered as completed.
More Information
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts
the PI's rights to discuss or publish trial results after the trial is completed.
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Results Point of Contact
Name/Title: | Pfizer ClinicalTrials.gov Call Center |
Organization: | Pfizer Inc. |
Phone: | 1-800-718-1021 |
EMail: | ClinicalTrials.gov_Inquiries@pfizer.com |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Pfizer |
ClinicalTrials.gov Identifier: | NCT00974311 |
Other Study ID Numbers: |
CRPC2 2009-013174-41 ( EudraCT Number ) C3431010 ( Other Identifier: Alias Study Number ) |
First Submitted: | September 9, 2009 |
First Posted: | September 10, 2009 |
Results First Submitted: | September 28, 2012 |
Results First Posted: | October 30, 2012 |
Last Update Posted: | December 11, 2018 |