Back to resultsZEN003694 and Enzalutamide Versus Enzalutamide Monotherapy in Metastatic Castration-Resistant Prostate Cancer
Primary Purpose
Metastatic Castration-Resistant Prostate Cancer
Status
Recruiting
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
ZEN003694
Enzalutamide
Sponsored by
About this trial
This is an interventional treatment trial for Metastatic Castration-Resistant Prostate Cancer focused on measuring mCRPC, ZEN003694, ZEN-3694, Bromodomain, BETi, Enzalutamide, Xtandi®
Eligibility Criteria
Inclusion Criteria:
- Males age ≥ 18 years
- Metastatic, castration-resistant, histologically confirmed prostate cancer
- Surgical castration or continuous medical castration for ≥ 8 weeks prior to screening; serum testosterone < 50 ng/dL confirmed within 4 weeks of first administration of study drug
- Have progressed on prior abiraterone treatment by PCWG3 criteria
- Patients who are not candidates for chemotherapy in the opinion of the investigator or patients who decline chemotherapy
Cohort A only - Patient must meet definition of poor responder to abiraterone by one of the following:
- Abiraterone started in hormone-sensitive prostate cancer (HSPC) disease setting: < 12 months duration on abiraterone or failure to achieve PSA nadir of 0.2 ng/mL while taking abiraterone
- Abiraterone started in castrate-resistant prostate cancer (CRPC) disease setting: < 6 months duration on abiraterone or failure to achieve a PSA50 response
Cohort B only - Patient must meet definition of responder to abiraterone by one of the following:
- Abiraterone started in hormone-sensitive prostate cancer (HSPC) disease setting: ≥ 12 months duration on abiraterone and nadir PSA < 0.2 ng/mL
- Abiraterone started in castrate-resistant prostate cancer (CRPC) disease setting: ≥ 6 months duration on abiraterone and PSA50 response
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Exclusion Criteria:
- Any history of brain metastases, prior seizure, conditions predisposing to seizure activity
- Have previously received an investigational BET inhibitor (including previous participation in this study or a study of ZEN003694)
- Receipt of prior second-generation androgen receptor inhibitors (e.g. enzalutamide, apalutamide, darolutamide, proxalutamide). Receipt of first-generation AR antagonists (e.g. bicalutamide, nilutamide, flutamide) does not count towards this limit.
- Have received prior chemotherapy in the metastatic castration-resistant setting (prior chemotherapy in the hormone-sensitive setting is allowed provided last dose was at least 6 months prior to first dose of study drug)
- Have received prior systemic anti-cancer therapy within 2 weeks or five half-lives, whichever is shorter, prior to the first administration of study drug
- Have received exogenous administration of testosterone therapy since discontinuation of abiraterone.
- Failure to recover to Grade 1 or lower toxicity related to prior systemic therapy (excluding alopecia and neuropathy) prior to study entry
- Radiation therapy within 2 weeks of the first administration of study drug
Sites / Locations
- University of California, San FranciscoRecruiting
- Innovative Clinical Research InstituteRecruiting
- Colorado UrologyRecruiting
- BRCR GlobalRecruiting
- Hematology Oncology Clinic
- University of Michigan Rogel Cancer CenterRecruiting
- Weill Cornell Medical College - New York Presbyterian Hospital
- Messino Cancer CenterRecruiting
- Seattle Cancer Care AllianceRecruiting
- Anhui Provincial HospitalRecruiting
- Chongqing Cancer HospitalRecruiting
- The First Affiliated Hospital of Xiamen UniversityRecruiting
- Henan Cancer HospitalRecruiting
- Tongji Hospital of Tongji Medical College, Huazhong University of Science & TechnologyRecruiting
- Hubei Cancer HospitalRecruiting
- Hunan Cancer HospitalRecruiting
- Nanjing Drum Tower HospitalRecruiting
- Liaoning Cancer Hospital
- The First Affiliated Hospital of Xi'an Jiaotang UniversityRecruiting
- Fudan University Shanghai Cancer CenterRecruiting
- Shanghai Tenth People's HospitalRecruiting
- First Hospital of Shanxi Medical UniversityRecruiting
- Sichuan Provincial People's HospitalRecruiting
- Zhejiang Provincial People's HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Active Comparator
Experimental
Active Comparator
Arm Label
Cohort A - ZEN003694 + Enzalutamide
Cohort A - Enzalutamide
Cohort B - ZEN003694 + Enzalutamide
Cohort B - Enzalutamide
Arm Description
Patients will be administered enzalutamide (160 mg) orally once daily for 21 days prior to the initiation of the combination therapy (Lead-in) to reach steady state concentration (Css) prior to Cycle 1. After the Lead-in, ZEN003694 (72 mg) will be administered orally one daily in combination with daily enzalutamide for 28-day cycles.
Patients will be administered enzalutamide (160 mg) orally once daily for 21 days prior to Cycle 1 Day 1 (Lead-in). After the Lead-in, patients will be administered enzalutamide 160 mg orally once daily for 28-day cycles. Active control patients will have the option to cross-over to treatment with ZEN003694 in combination with enzalutamide upon confirmed radiographic progression by PCWG3 criteria by independent central review.
Patients will be administered enzalutamide (160 mg) orally once daily for 21 days prior to the initiation of the combination therapy (Lead-in) to reach steady state concentration (Css) prior to Cycle 1. After the Lead-in, ZEN003694 (72 mg) will be administered orally one daily in combination with daily enzalutamide for 28-day cycles.
Patients will be administered enzalutamide (160 mg) orally once daily for 21 days prior to Cycle 1 Day 1 (Lead-in). After the Lead-in, patients will be administered enzalutamide 160 mg orally once daily for 28-day cycles. Active control patients will have the option to cross-over to treatment with ZEN003694 in combination with enzalutamide upon confirmed radiographic progression by PCWG3 criteria by independent central review.
Outcomes
Primary Outcome Measures
Cohort A: Radiographic progression-free survival (rPFS) by BICR
Time from date of randomization to the date of first disease radiographic progression or death for any reason. Radiographic progression disease will be evaluated by RECIST 1.1 and PCWG3.
Secondary Outcome Measures
Cohorts A + B: Radiographic progression-free survival (rPFS) by BICR
Time from date of randomization to the date of first disease radiographic progression or death for any reason. Radiographic progression disease will be evaluated by RECIST 1.1 and PCWG3
Cohort A: Radiographic progression-free survival (rPFS) by investigator assessment
Time from date of randomization to the date of first disease radiographic progression or death for any reason. Radiographic progression disease will be evaluated by RECIST 1.1 and PCWG3.
Cohort A + B: Radiographic progression-free survival (rPFS) by investigator assessment
Time from date of randomization to the date of first disease radiographic progression or death for any reason. Radiographic progression disease will be evaluated by RECIST 1.1 and PCWG3.
Cohort A: Progression-free survival (PFS) by investigator assessment
Time from date of randomization to the date of first disease radiographic progression, clinical progression, or death for any reason. Radiographic progression of disease will be evaluated by RECIST 1.1 and PCWG3 by investigator assessment. Clinical progression is significant pain increase or clinical deterioration that requires initiating another line of treatment.
Cohort A + B: Progression-free survival (PFS) by investigator assessment
Time from date of randomization to the date of first disease radiographic progression, clinical progression, or death for any reason. Radiographic progression of disease will be evaluated by RECIST 1.1 and PCWG3 by investigator assessment. Clinical progression is significant pain increase or clinical deterioration that requires initiating another line of treatment.
Cohort A: Overall survival (OS)
Time from date of randomization to the date of death from any cause
Cohort A + B: Overall survival (OS)
Time from date of randomization to the date of death from any cause
Cohort A: PSA50 response rate
PSA response is a reduction in serum PSA concentration of ≥50% from baseline.
Cohort A + B: PSA50 response rate
PSA response is a reduction in serum PSA concentration of ≥50% from baseline.
Objective response rate (ORR)
Proportion of the patients who have either a complete response (CR) or partial response (PR) by RECIST 1.1 criteria who have measurable disease at baseline.
Patient-reported health status and quality of life (QoL) measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)
EORTC QLQ-C30: cancer-specific instrument with 30 questions to assess the participant QoL. First 28 questions used to evaluate 5 functional scales (physical, role, cognitive, emotional, social), 3 symptom scales (fatigue, nausea and vomiting, pain) and other single items (dyspnea, appetite loss, insomnia, constipation, diarrhea, financial difficulties). Each question assessed on a 4-point scale (1= not at all, 2= a little, 3= quite a bit, 4= very much); functional scales: higher score = better level of functioning; symptom scale: higher score = more severe symptoms; for single items: higher score= more severe problem. Last 2 questions used to evaluate global health status (GHS)/QoL. Each question was assessed on 7-point scale (1= very poor to 7= excellent). Scores averaged, transformed to 0-100 scale; higher score=better quality of life/better level of functioning.
Patient-reported health status and quality of life (QoL) measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Prostate Module (EORTC QLQ-PR25).
EORTC QLQ-PR25: prostate cancer specific instrument with 25 questions used in conjunction with EORTC QLQ-C30 to assess the participant QoL. Used to evaluate 5 multi-item scales (urinary, bowel, and hormonal treatment-related symptoms, sexual activity, and sexual functioning) and one single item (problems due to incontinence aid use). Each question assessed on a 4-point scale (1= not at all, 2= a little, 3= quite a bit, 4= very much). Scores averaged, transformed to 0-100 scale; higher score=better quality of life/better level of functioning.
Time to initiation of chemotherapy
Time from date of randomization to the first dose of chemotherapy.
Time to first skeletal related event (SRE)
Time from date of randomization to the first SRE such as pathological fracture, surgery/radiotherapy for pain/prevention of fracture, hypercalcemia, and spinal cord compression.
Measure plasma concentrations of ZEN003694 and the active metabolite ZEN003791
Plasma concentrations of ZEN003694 and the active metabolite ZEN003791 will be measured.
Full Information
NCT ID
NCT04986423
First Posted
July 14, 2021
Last Updated
June 7, 2023
Sponsor
Zenith Epigenetics
Collaborators
Astellas Pharma Inc, Newsoara Biopharma Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT04986423
Brief Title
ZEN003694 and Enzalutamide Versus Enzalutamide Monotherapy in Metastatic Castration-Resistant Prostate Cancer
Official Title
A Randomized Phase 2b Study of ZEN003694 in Combination With Enzalutamide Versus Enzalutamide Monotherapy in Patients With Metastatic Castration-Resistant Prostate Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 8, 2021 (Actual)
Primary Completion Date
March 2024 (Anticipated)
Study Completion Date
September 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Zenith Epigenetics
Collaborators
Astellas Pharma Inc, Newsoara Biopharma Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This is an open-label, randomized, Phase 2b study of ZEN003694 in combination with enzalutamide vs. enzalutamide monotherapy in patients with mCRPC who have progressed on prior abiraterone by PCWG3 criteria. Disease must have progressed on only abiraterone by PCWG3 criteria prior to study entry.
The patient population will be separated into two cohorts:
Cohort A: Patients with poor response to prior abiraterone defined as:
Abiraterone started in hormone-sensitive prostate cancer (HSPC) disease setting: < 12 months duration on abiraterone or failure to achieve PSA nadir of 0.2 ng/mL while taking abiraterone, or;
Abiraterone started in castrate-resistant prostate cancer (CRPC) disease setting: < 6 months duration on abiraterone or failure to achieve PSA50 response while on abiraterone
Cohort B: Patients with response to prior abiraterone, defined as:
Abiraterone started in hormone-sensitive prostate cancer (HSPC) disease setting: ≥ 12 months duration on abiraterone and nadir PSA < 0.2 ng/mL, or;
Abiraterone started in castrate-resistant prostate cancer (CRPC) disease setting: ≥ 6 months duration on abiraterone and confirmed PSA50 response
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Castration-Resistant Prostate Cancer
Keywords
mCRPC, ZEN003694, ZEN-3694, Bromodomain, BETi, Enzalutamide, Xtandi®
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Cohort A - ZEN003694 + Enzalutamide
Arm Type
Experimental
Arm Description
Patients will be administered enzalutamide (160 mg) orally once daily for 21 days prior to the initiation of the combination therapy (Lead-in) to reach steady state concentration (Css) prior to Cycle 1. After the Lead-in, ZEN003694 (72 mg) will be administered orally one daily in combination with daily enzalutamide for 28-day cycles.
Arm Title
Cohort A - Enzalutamide
Arm Type
Active Comparator
Arm Description
Patients will be administered enzalutamide (160 mg) orally once daily for 21 days prior to Cycle 1 Day 1 (Lead-in). After the Lead-in, patients will be administered enzalutamide 160 mg orally once daily for 28-day cycles. Active control patients will have the option to cross-over to treatment with ZEN003694 in combination with enzalutamide upon confirmed radiographic progression by PCWG3 criteria by independent central review.
Arm Title
Cohort B - ZEN003694 + Enzalutamide
Arm Type
Experimental
Arm Description
Patients will be administered enzalutamide (160 mg) orally once daily for 21 days prior to the initiation of the combination therapy (Lead-in) to reach steady state concentration (Css) prior to Cycle 1. After the Lead-in, ZEN003694 (72 mg) will be administered orally one daily in combination with daily enzalutamide for 28-day cycles.
Arm Title
Cohort B - Enzalutamide
Arm Type
Active Comparator
Arm Description
Patients will be administered enzalutamide (160 mg) orally once daily for 21 days prior to Cycle 1 Day 1 (Lead-in). After the Lead-in, patients will be administered enzalutamide 160 mg orally once daily for 28-day cycles. Active control patients will have the option to cross-over to treatment with ZEN003694 in combination with enzalutamide upon confirmed radiographic progression by PCWG3 criteria by independent central review.
Intervention Type
Drug
Intervention Name(s)
ZEN003694
Other Intervention Name(s)
ZEN-3694
Intervention Description
72 mg PO QD
Intervention Type
Drug
Intervention Name(s)
Enzalutamide
Other Intervention Name(s)
Xtandi®, MDV3100
Intervention Description
160 mg PO QD
Primary Outcome Measure Information:
Title
Cohort A: Radiographic progression-free survival (rPFS) by BICR
Description
Time from date of randomization to the date of first disease radiographic progression or death for any reason. Radiographic progression disease will be evaluated by RECIST 1.1 and PCWG3.
Time Frame
Randomization up to 30 months
Secondary Outcome Measure Information:
Title
Cohorts A + B: Radiographic progression-free survival (rPFS) by BICR
Description
Time from date of randomization to the date of first disease radiographic progression or death for any reason. Radiographic progression disease will be evaluated by RECIST 1.1 and PCWG3
Time Frame
Randomization up to 30 months
Title
Cohort A: Radiographic progression-free survival (rPFS) by investigator assessment
Description
Time from date of randomization to the date of first disease radiographic progression or death for any reason. Radiographic progression disease will be evaluated by RECIST 1.1 and PCWG3.
Time Frame
Randomization up to 30 months
Title
Cohort A + B: Radiographic progression-free survival (rPFS) by investigator assessment
Description
Time from date of randomization to the date of first disease radiographic progression or death for any reason. Radiographic progression disease will be evaluated by RECIST 1.1 and PCWG3.
Time Frame
Randomization up to 30 months
Title
Cohort A: Progression-free survival (PFS) by investigator assessment
Description
Time from date of randomization to the date of first disease radiographic progression, clinical progression, or death for any reason. Radiographic progression of disease will be evaluated by RECIST 1.1 and PCWG3 by investigator assessment. Clinical progression is significant pain increase or clinical deterioration that requires initiating another line of treatment.
Time Frame
Randomization up to 30 months
Title
Cohort A + B: Progression-free survival (PFS) by investigator assessment
Description
Time from date of randomization to the date of first disease radiographic progression, clinical progression, or death for any reason. Radiographic progression of disease will be evaluated by RECIST 1.1 and PCWG3 by investigator assessment. Clinical progression is significant pain increase or clinical deterioration that requires initiating another line of treatment.
Time Frame
Randomization up to 30 months
Title
Cohort A: Overall survival (OS)
Description
Time from date of randomization to the date of death from any cause
Time Frame
Randomization up to 30 months
Title
Cohort A + B: Overall survival (OS)
Description
Time from date of randomization to the date of death from any cause
Time Frame
Randomization up to 30 months
Title
Cohort A: PSA50 response rate
Description
PSA response is a reduction in serum PSA concentration of ≥50% from baseline.
Time Frame
Randomization up to 30 months
Title
Cohort A + B: PSA50 response rate
Description
PSA response is a reduction in serum PSA concentration of ≥50% from baseline.
Time Frame
Randomization up to 30 months
Title
Objective response rate (ORR)
Description
Proportion of the patients who have either a complete response (CR) or partial response (PR) by RECIST 1.1 criteria who have measurable disease at baseline.
Time Frame
Randomization up to 30 months
Title
Patient-reported health status and quality of life (QoL) measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)
Description
EORTC QLQ-C30: cancer-specific instrument with 30 questions to assess the participant QoL. First 28 questions used to evaluate 5 functional scales (physical, role, cognitive, emotional, social), 3 symptom scales (fatigue, nausea and vomiting, pain) and other single items (dyspnea, appetite loss, insomnia, constipation, diarrhea, financial difficulties). Each question assessed on a 4-point scale (1= not at all, 2= a little, 3= quite a bit, 4= very much); functional scales: higher score = better level of functioning; symptom scale: higher score = more severe symptoms; for single items: higher score= more severe problem. Last 2 questions used to evaluate global health status (GHS)/QoL. Each question was assessed on 7-point scale (1= very poor to 7= excellent). Scores averaged, transformed to 0-100 scale; higher score=better quality of life/better level of functioning.
Time Frame
Screening and Day 1 of every 28-day Cycle up to 30 months
Title
Patient-reported health status and quality of life (QoL) measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Prostate Module (EORTC QLQ-PR25).
Description
EORTC QLQ-PR25: prostate cancer specific instrument with 25 questions used in conjunction with EORTC QLQ-C30 to assess the participant QoL. Used to evaluate 5 multi-item scales (urinary, bowel, and hormonal treatment-related symptoms, sexual activity, and sexual functioning) and one single item (problems due to incontinence aid use). Each question assessed on a 4-point scale (1= not at all, 2= a little, 3= quite a bit, 4= very much). Scores averaged, transformed to 0-100 scale; higher score=better quality of life/better level of functioning.
Time Frame
Screening and Day 1 of every 28-day Cycle up to 30 months
Title
Time to initiation of chemotherapy
Description
Time from date of randomization to the first dose of chemotherapy.
Time Frame
Randomization up to 30 months
Title
Time to first skeletal related event (SRE)
Description
Time from date of randomization to the first SRE such as pathological fracture, surgery/radiotherapy for pain/prevention of fracture, hypercalcemia, and spinal cord compression.
Time Frame
Randomization up to 30 months
Title
Measure plasma concentrations of ZEN003694 and the active metabolite ZEN003791
Description
Plasma concentrations of ZEN003694 and the active metabolite ZEN003791 will be measured.
Time Frame
Cycle 1 Day 1: Pre-dose, 1 hour, 2 hours, and 4 hours post-dose; Cycle 2 Day1: Pre-dose, 1 hour, 2 hours, and 4 hours post-dose
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Males age ≥ 18 years
Metastatic, castration-resistant, histologically confirmed prostate cancer
Surgical castration or continuous medical castration for ≥ 8 weeks prior to screening; serum testosterone < 50 ng/dL confirmed within 4 weeks of first administration of study drug
Have progressed on prior abiraterone treatment by PCWG3 criteria
Patients who are not candidates for chemotherapy in the opinion of the investigator or patients who decline chemotherapy
Cohort A only - Patient must meet definition of poor responder to abiraterone by one of the following:
Abiraterone started in hormone-sensitive prostate cancer (HSPC) disease setting: < 12 months duration on abiraterone or failure to achieve PSA nadir of 0.2 ng/mL while taking abiraterone
Abiraterone started in castrate-resistant prostate cancer (CRPC) disease setting: < 6 months duration on abiraterone or failure to achieve a PSA50 response
Cohort B only - Patient must meet definition of responder to abiraterone by one of the following:
Abiraterone started in hormone-sensitive prostate cancer (HSPC) disease setting: ≥ 12 months duration on abiraterone and nadir PSA < 0.2 ng/mL
Abiraterone started in castrate-resistant prostate cancer (CRPC) disease setting: ≥ 6 months duration on abiraterone and PSA50 response
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Exclusion Criteria:
Any history of brain metastases, prior seizure, conditions predisposing to seizure activity
Have previously received an investigational BET inhibitor (including previous participation in this study or a study of ZEN003694)
Receipt of prior second-generation androgen receptor inhibitors (e.g. enzalutamide, apalutamide, darolutamide, proxalutamide). Receipt of first-generation AR antagonists (e.g. bicalutamide, nilutamide, flutamide) does not count towards this limit.
Have received prior chemotherapy in the metastatic castration-resistant setting (prior chemotherapy in the hormone-sensitive setting is allowed provided last dose was at least 6 months prior to first dose of study drug)
Have received prior systemic anti-cancer therapy within 2 weeks or five half-lives, whichever is shorter, prior to the first administration of study drug
Have received exogenous administration of testosterone therapy since discontinuation of abiraterone.
Failure to recover to Grade 1 or lower toxicity related to prior systemic therapy (excluding alopecia and neuropathy) prior to study entry
Radiation therapy within 2 weeks of the first administration of study drug
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zenith Study Team
Phone
587-390-7865
Email
ZEN003694-201@zenithepigenetics.com
Facility Information:
Facility Name
University of California, San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94158
Country
United States
Individual Site Status
Recruiting
Facility Name
Innovative Clinical Research Institute
City
Whittier
State/Province
California
ZIP/Postal Code
90603
Country
United States
Individual Site Status
Recruiting
Facility Name
Colorado Urology
City
Lakewood
State/Province
Colorado
ZIP/Postal Code
80228
Country
United States
Individual Site Status
Recruiting
Facility Name
BRCR Global
City
Plantation
State/Province
Florida
ZIP/Postal Code
33322
Country
United States
Individual Site Status
Recruiting
Facility Name
Hematology Oncology Clinic
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70809
Country
United States
Individual Site Status
Withdrawn
Facility Name
University of Michigan Rogel Cancer Center
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Individual Site Status
Recruiting
Facility Name
Weill Cornell Medical College - New York Presbyterian Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Individual Site Status
Completed
Facility Name
Messino Cancer Center
City
Asheville
State/Province
North Carolina
ZIP/Postal Code
28806
Country
United States
Individual Site Status
Recruiting
Facility Name
Seattle Cancer Care Alliance
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States
Individual Site Status
Recruiting
Facility Name
Anhui Provincial Hospital
City
Hefei
State/Province
Anhui
ZIP/Postal Code
230002
Country
China
Individual Site Status
Recruiting
Facility Name
Chongqing Cancer Hospital
City
Chongqing
State/Province
Chongqing
ZIP/Postal Code
400030
Country
China
Individual Site Status
Recruiting
Facility Name
The First Affiliated Hospital of Xiamen University
City
Xiamen
State/Province
Fujian
ZIP/Postal Code
361003
Country
China
Individual Site Status
Recruiting
Facility Name
Henan Cancer Hospital
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
450000
Country
China
Individual Site Status
Recruiting
Facility Name
Tongji Hospital of Tongji Medical College, Huazhong University of Science & Technology
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430030
Country
China
Individual Site Status
Recruiting
Facility Name
Hubei Cancer Hospital
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430079
Country
China
Individual Site Status
Recruiting
Facility Name
Hunan Cancer Hospital
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410006
Country
China
Individual Site Status
Recruiting
Facility Name
Nanjing Drum Tower Hospital
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210008
Country
China
Individual Site Status
Recruiting
Facility Name
Liaoning Cancer Hospital
City
Shenyang
State/Province
Liaoning
ZIP/Postal Code
110042
Country
China
Individual Site Status
Not yet recruiting
Facility Name
The First Affiliated Hospital of Xi'an Jiaotang University
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
71000
Country
China
Individual Site Status
Recruiting
Facility Name
Fudan University Shanghai Cancer Center
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China
Individual Site Status
Recruiting
Facility Name
Shanghai Tenth People's Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200072
Country
China
Individual Site Status
Recruiting
Facility Name
First Hospital of Shanxi Medical University
City
Taiyuan
State/Province
Shanxi
ZIP/Postal Code
030001
Country
China
Individual Site Status
Recruiting
Facility Name
Sichuan Provincial People's Hospital
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610072
Country
China
Individual Site Status
Recruiting
Facility Name
Zhejiang Provincial People's Hospital
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310014
Country
China
Individual Site Status
Recruiting
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
ZEN003694 and Enzalutamide Versus Enzalutamide Monotherapy in Metastatic Castration-Resistant Prostate Cancer
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