A Study to Evaluate the Potential Increased Risk of Seizures Among Metastatic Castration-Resistant Prostate Cancer (mCRPC) Patients Treated With Enzalutamide (UPWARD)
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|ClinicalTrials.gov Identifier: NCT01977651|
Recruitment Status : Completed
First Posted : November 7, 2013
Last Update Posted : January 14, 2020
|Condition or disease||Intervention/treatment||Phase|
|Metastatic Castration-resistant Prostate Cancer (mCRPC)||Drug: enzalutamide||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||424 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Multicenter, Single-arm, Open-label, Postmarketing Safety Study to Evaluate the Risk of Seizure Among Subjects With Metastatic Castration-Resistant Prostate Cancer (mCRPC) Treated With Enzalutamide Who Are at Potential Increased Risk of Seizure|
|Actual Study Start Date :||September 25, 2013|
|Actual Primary Completion Date :||February 1, 2016|
|Actual Study Completion Date :||January 11, 2019|
Experimental: Enzalutamide 160 mg
Participants will receive 160 mg of enzalutamide orally once a day, for 4 months.
Participants will receive 4 capsules (40 mg each) of enzalutamide orally once a day, for a total daily dose of 160 mg. Treatment will be given with or without food and as close as possible to the same time each day.
- The Percentage of Evaluable Participants With at Least One Confirmed Seizure as Adjudicated by the Independent Adjudication Committee (IAC) [ Time Frame: Day 1 up to Week 17 (End of Treatment) ]Evaluable participant is defined as a participant with a confirmed seizure during the 4-month treatment period of the study or a participant who completes at least 3 months (75%) of the planned treatment.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01977651
|Study Director:||Sr. Medical Director||Astellas Pharma Global Development, Inc.|