- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01597193
Safety Study of Enzalutamide (MDV3100) in Patients With Incurable Breast Cancer
May 7, 2019 updated by: Pfizer
A PHASE 1 OPEN-LABEL, DOSE ESCALATION STUDY EVALUATING THE SAFETY, TOLERABILITY, AND PHARMACOKINETICS OF ENZALUTAMIDE (FORMERLY MDV3100) IN PATIENTS WITH INCURABLE BREAST CANCER
The purpose of this study is to determine the safety, tolerability and pharmacokinetics of enzalutamide alone and in combination with anastrozole, or exemestane, or fulvestrant in patients with incurable breast cancer.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
101
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Colorado
-
Aurora, Colorado, United States, 80045
- University of Colorado Cancer Center
-
Aurora, Colorado, United States, 80045
- ATTN-Research Pharmacist
-
Aurora, Colorado, United States, 80045
- University of Colorado Hospital, Anschutz Outpatient Pavilion
-
-
Connecticut
-
Enfield, Connecticut, United States, 06082
- Connecticut Multispecialty Group
-
-
Florida
-
Sarasota, Florida, United States, 34232
- Florida Cancer Specialists
-
-
Michigan
-
Detroit, Michigan, United States, 48201
- Karmanos Cancer Institute
-
-
Mississippi
-
Corinth, Mississippi, United States, 38834
- The West Clinic, PC
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Southaven, Mississippi, United States, 38671
- The West Clinic
-
-
New York
-
New York, New York, United States, 10065
- Memorial Sloan Kettering Cancer Center
-
New York, New York, United States, 10022
- Memorial Sloan Kettering Cancer Center
-
New York, New York, United States, 10065
- Memorial Sloan Kettering Cancer Center - IDS Pharmacy
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New York, New York, United States, 10065
- Memorial Sloan Kettering Cancer Center - OPD Pharmacy
-
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Tennessee
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Germantown, Tennessee, United States, 38138
- The West Clinic
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Memphis, Tennessee, United States, 38120
- The West Clinic
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Memphis, Tennessee, United States, 38104
- The West Clinic
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Nashville, Tennessee, United States, 37203
- The Sarah Cannon Research Institute
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Nashville, Tennessee, United States, 37203
- Tennessee Oncology, PLLC.
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Histologically confirmed breast cancer with accompanying pathology report;
- Submit unstained representative tumor specimen, either as a paraffin block (preferred) or ≥ 10 unstained slides
- Received at least 2 lines of systemic therapy in the advanced setting (for enzalutamide alone arm only);
- Eastern Cooperative Oncology Group performance (ECOG) status of 0 or 1;
- Estimated life expectancy of at least 3 months
Exclusion Criteria:
- Severe concurrent disease, infection, or comorbidity that, in the judgment of the Investigator, would make the patient inappropriate for enrollment;
- Pregnant or lactating;
- Known or suspected brain metastasis or leptomeningeal disease;
- History of another malignancy within the previous 5 years other than curatively treated in situ carcinomas;
- For patients who are enrolled to receive enzalutamide plus anastrozole or exemestane or fulvestrant must not have received tamoxifen or any medication known to be a potent CYP3A4 inducer or inhibitor.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: enzalutamide (80-mg with increase to 160 mg)
enzalutamide be provided as two or four 40-mg capsules by mouth daily
|
80 mg (2 capsules) or 160 mg (4 capsules) taken orally daily.
Other Names:
160 mg (4 capsules) taken orally daily.
Other Names:
|
Experimental: enzalutamide and anastrozole
enzalutamide (160 mg) administered as four 40-mg capsules by mouth once daily in combination with anastrozole (1 mg) administered as one 1-mg tablet by mouth once daily.
|
80 mg (2 capsules) or 160 mg (4 capsules) taken orally daily.
Other Names:
160 mg (4 capsules) taken orally daily.
Other Names:
1 mg/day
Other Names:
|
Experimental: enzalutamide and exemestane 25 mg
enzalutamide (160 mg) administered as four 40-mg capsules by mouth once daily in combination with exemestane administered as one 25-mg tablet daily
|
80 mg (2 capsules) or 160 mg (4 capsules) taken orally daily.
Other Names:
160 mg (4 capsules) taken orally daily.
Other Names:
The exemestane dose is 25mg daily.
Other Names:
The exemestane dose is 50 mg daily.
Other Names:
|
Experimental: enzalutamide and exemestane 50 mg
enzalutamide (160 mg) administered as four 40-mg capsules by mouth once daily in combination with exemestane administered as two 25-mg tablets daily
|
80 mg (2 capsules) or 160 mg (4 capsules) taken orally daily.
Other Names:
160 mg (4 capsules) taken orally daily.
Other Names:
The exemestane dose is 25mg daily.
Other Names:
The exemestane dose is 50 mg daily.
Other Names:
|
Experimental: enzalutamide and fulvestrant
enzalutamide (160 mg) administered as four 40-mg capsules by mouth once daily in combination with fulvestrant (500 mg) administered as two 250-mg intramuscular injections every 28 days
|
80 mg (2 capsules) or 160 mg (4 capsules) taken orally daily.
Other Names:
160 mg (4 capsules) taken orally daily.
Other Names:
500 mg every 28 days
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Dose-Escalation Phase: Percentage of Participants With Dose-limiting Toxicity (DLTs)
Time Frame: Baseline up to Day 35
|
DLTs were defined as any of following events related to the study drug: Any adverse event (AE) consistent with a seizure of any grade; Grade greater than equal to (>=) 3 fatigue, diarrhea, nausea, or vomiting that did not improve to Grade 1 within 14 days of initiating standard of care therapy; any Grade >=3 hematologic toxicity with the following modifications: 1) Grade >=3 platelet count associated with bleeding, 2) Grade >=3 absolute neutrophil count that persists for 7 or more days or that was associated with fevers (febrile neutropenia); Grade >=3 any other non-hematological toxicity that was determined to be related to study drug.
|
Baseline up to Day 35
|
Percentage of Participants With Adverse Events of Grade 3 or Higher Severity by National Cancer Institute Common Toxicity Criteria For Adverse Events (NCI CTCAE) (Version 4.03)
Time Frame: Day 1 up to 30 days after the last dose of study drug or before initiation of a new systemic antitumor treatment, whichever occurred first (up to 3.5 years)
|
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.
AE was assessed according to severity grading based on NCI CTCAE Version 4.03 and defined as Grade 3 AEs = severe or medically significant events but not immediately life-threatening, hospitalization or prolongation of hospitalization indicated, disabling, limiting self-care activities of daily living; Grade 4 AEs = life-threatening, urgent intervention indicated; Grade 5 AEs = death related to adverse event.
|
Day 1 up to 30 days after the last dose of study drug or before initiation of a new systemic antitumor treatment, whichever occurred first (up to 3.5 years)
|
Percentage of Participants With Treatment-Emergent Serious Adverse Events (SAEs)
Time Frame: Day 1 up to 30 days after the last dose of study drug or before initiation of a new systemic antitumor treatment, whichever occurred first (up to 3.5 years)
|
An AE was any untoward medical occurrence in a participant who received study treatment without regard to possibility of causal relationship.
SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death, initial or prolonged inpatient hospitalization, life-threatening experience (immediate risk of dying), persistent or significant disability or incapacity, congenital anomaly.
Treatment-emergent are events between first dose of study drug and up to 30 days after last dose of study drug that were absent before treatment or that worsened relative to pretreatment state.
AEs included both serious and non-serious adverse events.
|
Day 1 up to 30 days after the last dose of study drug or before initiation of a new systemic antitumor treatment, whichever occurred first (up to 3.5 years)
|
Percentage of Participants Who Discontinued the Study Drug Due to Adverse Events or Serious Adverse Events
Time Frame: Day 1 up to 30 days after the last dose of study drug or before initiation of a new systemic antitumor treatment, whichever occurred first (up to 3.5 years)
|
An AE was any untoward medical occurrence in a participant who received study treatment without regard to possibility of causal relationship.
SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death, initial or prolonged inpatient hospitalization, life-threatening experience (immediate risk of dying), persistent or significant disability or incapacity, congenital anomaly.
|
Day 1 up to 30 days after the last dose of study drug or before initiation of a new systemic antitumor treatment, whichever occurred first (up to 3.5 years)
|
Percentage of Participants Who Require Dose Reductions Due to Adverse Events
Time Frame: Day 1 up to 30 days after the last dose of study drug or before initiation of a new systemic antitumor treatment, whichever occurred first (up to 3.5 years)
|
An AE was any untoward medical occurrence in a participant who received study treatment without regard to possibility of causal relationship.
SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death, initial or prolonged inpatient hospitalization, life-threatening experience (immediate risk of dying), persistent or significant disability or incapacity, congenital anomaly.
|
Day 1 up to 30 days after the last dose of study drug or before initiation of a new systemic antitumor treatment, whichever occurred first (up to 3.5 years)
|
Percentage of Participants With Potentially Clinically Significant Change From Baseline in Vital Signs
Time Frame: Day 1 up to 30 days after the last dose of study drug or before initiation of a new systemic antitumor treatment, whichever occurred first (up to 3.5 years)
|
Absolute systolic blood pressure (SBP) greater than (>) 180 millimeter of mercury (mm Hg) and an increase of >40 mm Hg from baseline; absolute SBP less than (<) 90 mm Hg and an decrease of >30 mm Hg from baseline.
Absolute diastolic blood pressure (DBP) >105 mm Hg and an increase of >30 mm Hg from baseline; absolute DBP <50 mm Hg and an increase of >20 mm Hg from baseline.
Absolute heart rate >120 beats per minute (bpm) and an increase of >30 bpm from baseline; absolute heart rate <50 bpm and decrease of >20 bpm from baseline.
Participants with any of these abnormalities were reported for this outcome in each arm.
|
Day 1 up to 30 days after the last dose of study drug or before initiation of a new systemic antitumor treatment, whichever occurred first (up to 3.5 years)
|
Dose-Escalation Phase: Maximum Plasma Concentration (Cmax) of Enzalutamide and Its Metabolites After Single Dose
Time Frame: pre-dose, 0.5, 1, 2, 4, 6, 24, 48, 72 and 96 hours post dose on Day 1
|
Carboxylic Acid (M1) and N-desmethyl (M2) are two metabolites of Enzalutamide.
|
pre-dose, 0.5, 1, 2, 4, 6, 24, 48, 72 and 96 hours post dose on Day 1
|
Dose-Escalation Phase: Time to Reach Maximum Plasma Concentration (Tmax) of Enzalutamide and Its Metabolites After Single Dosing
Time Frame: pre-dose, 0.5, 1, 2, 4, 6, 24, 48, 72 and 96 hours post dose on Day 1
|
Carboxylic Acid (M1) and N-desmethyl (M2) are two metabolites of Enzalutamide.
|
pre-dose, 0.5, 1, 2, 4, 6, 24, 48, 72 and 96 hours post dose on Day 1
|
Dose-Escalation Phase: Area Under the Plasma Concentration-time Curve From Time Zero to 24 Hours (AUC24h) of Enzalutamide and Its Metabolites After Single Dose
Time Frame: pre-dose, 0.5, 1, 2, 4, 6 and 24 hours post dose on Day 1
|
Carboxylic Acid (M1) and N-desmethyl (M2) are two metabolites of Enzalutamide.
|
pre-dose, 0.5, 1, 2, 4, 6 and 24 hours post dose on Day 1
|
Dose-Escalation Phase: Area Under the Plasma Concentration-time Curve From Time Zero to 72 Hours (AUC72h) of Enzalutamide After Single Dosing
Time Frame: pre-dose, 0.5, 1, 2, 4, 6, 24, 48 and 72 hours post dose on Day 1
|
pre-dose, 0.5, 1, 2, 4, 6, 24, 48 and 72 hours post dose on Day 1
|
|
Dose-Escalation Phase: Area Under the Plasma Concentration-Time Profile From Time Zero Extrapolated to Infinite Time (AUCinf) of Enzalutamide After Single Dosing
Time Frame: pre-dose, 0.5, 1, 2, 4, 6, 24, 48, 72 and 96 hours post dose on Day 1
|
AUCinf = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - inf).
|
pre-dose, 0.5, 1, 2, 4, 6, 24, 48, 72 and 96 hours post dose on Day 1
|
Dose-Escalation Phase: Terminal Elimination Half-Life (t1/2) of Enzalutamide After Single Dosing
Time Frame: pre-dose, 0.5, 1, 2, 4, 6, 24, 48, 72 and 96 hours post dose on Day 1
|
Terminal elimination half-life is the time measured for the plasma concentration of Enzalutamide to decrease by one-half of its initial concentration.
|
pre-dose, 0.5, 1, 2, 4, 6, 24, 48, 72 and 96 hours post dose on Day 1
|
Dose Escalation Phase: Apparent Oral Clearance (CL/F) of Enzalutamide After Single Dosing
Time Frame: pre-dose, 0.5, 1, 2, 4, 6, 24, 48, 72 and 96 hours post dose on Day 1
|
Apparent oral clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes.
It was obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed.
|
pre-dose, 0.5, 1, 2, 4, 6, 24, 48, 72 and 96 hours post dose on Day 1
|
Dose Escalation Phase: Apparent Volume of Distribution (Vz/F) of Enzalutamide After Single Dosing
Time Frame: pre-dose, 0.5, 1, 2, 4, 6, 24, 48, 72 and 96 hours post dose on Day 1
|
Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug.
Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed.
|
pre-dose, 0.5, 1, 2, 4, 6, 24, 48, 72 and 96 hours post dose on Day 1
|
Dose-Escalation Phase: Maximum Plasma Concentration (Cmax) of Enzalutamide and Its Metabolites After Multiple Dosing
Time Frame: pre-dose, 0.5, 1, 2, 4, 6, and 24 hours post-dose on Day 50
|
Carboxylic Acid (M1) and N-desmethyl (M2) are two metabolites of Enzalutamide.
|
pre-dose, 0.5, 1, 2, 4, 6, and 24 hours post-dose on Day 50
|
Dose-Escalation Phase: Time to Reach Maximum Plasma Concentration (Tmax) of Enzalutamide and Its Metabolites After Multiple Dosing
Time Frame: pre-dose, 0.5, 1, 2, 4, 6, and 24 hours post-dose on Day 50
|
Carboxylic Acid (M1) and N-desmethyl (M2) are two metabolites of Enzalutamide.
|
pre-dose, 0.5, 1, 2, 4, 6, and 24 hours post-dose on Day 50
|
Dose-Escalation Phase: Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of Enzalutamide and Its Metabolites After Multiple Dosing
Time Frame: pre-dose, 0.5, 1, 2, 4, 6, and 24 hours post-dose on Day 50
|
Area under the plasma concentration versus time-curve from time zero to end of dosing interval (AUCtau), where dosing interval was 24 hours.
Carboxylic Acid (M1) and N-desmethyl (M2) are two metabolites of Enzalutamide.
|
pre-dose, 0.5, 1, 2, 4, 6, and 24 hours post-dose on Day 50
|
Dose-Escalation Phase: Apparent Oral Clearance (CL/F) of Enzalutamide After Multiple Dosing
Time Frame: pre-dose, 0.5, 1, 2, 4, 6, and 24 hours post-dose on Day 50
|
Apparent oral clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes.
It was obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed.
|
pre-dose, 0.5, 1, 2, 4, 6, and 24 hours post-dose on Day 50
|
Dose-Escalation Phase: Peak-to-Trough Ratio of Enzalutamide and Its Metabolites After Multiple Dosing
Time Frame: pre-dose, 0.5, 1, 2, 4, 6, and 24 hours post-dose on Day 50
|
Peak-to-trough ratio was calculated by dividing Cmax with Cmin of Enzalutamide and its Metabolites.
Carboxylic Acid (M1) and N-desmethyl (M2) are two metabolites of Enzalutamide.
Cmax was maximum plasma concentration during the dosing interval and Cmin was minimum observed plasma concentration during the dosing interval.
|
pre-dose, 0.5, 1, 2, 4, 6, and 24 hours post-dose on Day 50
|
Dose-Escalation Phase: Accumulation Ratio of AUC24 of Enzalutamide and Its Metabolites After Multiple Dosing
Time Frame: pre-dose, 0.5, 1, 2, 4, 6, and 24 hours post-dose on Day 1 and 50
|
Accumulation Ratio was defined as the ratio of AUC24 of Day 50 to AUC24 of Day 1, where AUC24 was area under the plasma concentration-time curve from time zero to 24 hours post-dose.
Carboxylic Acid (M1) and N-desmethyl (M2) are two metabolites of Enzalutamide.
|
pre-dose, 0.5, 1, 2, 4, 6, and 24 hours post-dose on Day 1 and 50
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Dose-Expansion Phase: Trough Plasma Concentration for Enzalutamide
Time Frame: pre-dose on Day 57
|
pre-dose on Day 57
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 30, 2012
Primary Completion (Actual)
December 15, 2015
Study Completion (Actual)
January 22, 2018
Study Registration Dates
First Submitted
May 9, 2012
First Submitted That Met QC Criteria
May 9, 2012
First Posted (Estimate)
May 11, 2012
Study Record Updates
Last Update Posted (Actual)
May 8, 2019
Last Update Submitted That Met QC Criteria
May 7, 2019
Last Verified
May 1, 2019
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Skin Diseases
- Neoplasms
- Neoplasms by Site
- Breast Diseases
- Breast Neoplasms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antineoplastic Agents
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Antineoplastic Agents, Hormonal
- Hormone Antagonists
- Aromatase Inhibitors
- Steroid Synthesis Inhibitors
- Estrogen Antagonists
- Estrogen Receptor Antagonists
- Fulvestrant
- Anastrozole
- Exemestane
Other Study ID Numbers
- MDV3100-08
- C3431006 (Other Identifier: Alias Study Number)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
IPD Plan Description
Pfizer will provide access to individual de-identified participant data and related study documents (e.g.
protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions.
Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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