Phase
Condition
Urologic Cancer
Prostate Disorders
Prostate Cancer
Treatment
INV-9956
Clinical Study ID
Ages > 18 Male
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Written informed consent obtained.
Male aged ≥ 18 years.
Histologically confirmed adenocarcinoma of the prostate.
Castration resistant prostate cancer with serum testosterone <50 ng/dL.
Metastatic disease.
Ongoing androgen deprivation therapy with GnRH analogue or antagonist, or have hadbilateral orchiectomy.
Received at least one prior line of taxane-based chemotherapy and at least one lineof hormonal AR targeted therapy (eg, abiraterone, enzalutamide). Patients who haverefused or were intolerant to taxane-based chemotherapy may be enrolled.
ECOG performance status 0-1.
Adequate marrow, liver and kidney function.
INR ≤1.5.
Able to swallow study treatment.
Has a life expectancy of > 3 months.
Exclusion
Exclusion Criteria:
Have a medical condition such as Crohn's disease or have undergone significantsurgery to the gastrointestinal tract that could impair absorption or that couldresult in short bowel syndrome with diarrhea due to malabsorption.
History of pituitary or adrenal dysfunction.
Poorly controlled diabetes mellitus.
Clinically significant abnormality in serum potassium and sodium.
Have a serious nonmalignant disease (eg, hydronephrosis, liver failure, or otherconditions) that could compromise protocol objectives in the opinion of theInvestigator and/or the Sponsor.
Active or unstable cardio-/cerebro-vascular disease, including thromboembolicevents.
History of congestive heart failure; cardiac disease, myocardial infarction within 6months prior to enrollment.
Prolonged QTcF interval.
Active infection or other medical condition that would make corticosteroidcontraindicated.
Study Design
Study Description
Connect with a study center
The First Affiliated Hospital of Fujian Medical University
Fuzhou 1810821, Fujian 1811017 350005
ChinaSite Not Available
He'nan Cancer Hospital
Zhengzhou 1784658, He'Nan 450000
ChinaActive - Recruiting
Hu'nan Cancer Hospital
Changsha 1815577, Hu'Nan 410006
ChinaSite Not Available
Nanjing Drum Tower Hospital
Nanjing 1799962, Jiangsu 1806260 210008
ChinaActive - Recruiting
Liaoning Cancer Hospital
Shenyang 2034937, Liaoning 2036115 110801
ChinaActive - Recruiting
Shandong Cancer Hospital
Ji'nan, Shandong 1796328 250000
ChinaActive - Recruiting
Fudan University Shanghai Cancer Center
Shanghai, Shanghai 200032
ChinaSite Not Available
Fudan University Shanghai Cancer Center
Shanghai 1796236, Shanghai Municipality 1796231 200032
ChinaSite Not Available
Tianjin Medical University Cancer Institute & Hospital
Tianjin 1792947, Tianjin Municipality 1792943 300202
ChinaActive - Recruiting
The First Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou 1808926, Zhejiang 1784764 310003
ChinaActive - Recruiting
Zhejiang Provincial People's Hospital
Hangzhou 1808926, Zhejiang 1784764 310014
ChinaSite Not Available
Honor Health
Scottsdale, Arizona 85258
United StatesSite Not Available
Honor Health
Scottsdale 5313457, Arizona 5551752 85258
United StatesActive - Recruiting
Hoag Family Cancer Institute
Newport Beach, California 92663
United StatesSite Not Available
UC Irvine Medical Center
Orange, California 92868
United StatesSite Not Available
Hoag Family Cancer Institute
Newport Beach 5376890, California 5332921 92663
United StatesSite Not Available
UC Irvine Medical Center
Orange 5379513, California 5332921 92868
United StatesActive - Recruiting
Next Oncology - Houston
Houston, Texas 77054
United StatesSite Not Available
NEXT Oncology
San Antonio, Texas 78229
United StatesSite Not Available
UT Health
San Antonio, Texas 78229
United StatesActive - Recruiting
Next Oncology - Houston
Houston 4699066, Texas 4736286 77054
United StatesActive - Recruiting
UT Health
San Antonio 4726206, Texas 4736286 78229
United StatesActive - Recruiting
NEXT Oncology
Fairfax, Virginia 22031
United StatesSite Not Available
NEXT Oncology
Fairfax 4758023, Virginia 6254928 22031
United StatesActive - Recruiting
Summit Cancer Centers
Spokane, Washington 99208
United StatesSite Not Available
Summit Cancer Centers
Spokane 5811696, Washington 5815135 99208
United StatesSite Not Available

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