A Phase 1 and Phase 2, Multi-Center, Open-Label Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Preliminary Evidence of Antitumor Activity of INV-9956 in Adult Patients With Advanced Metastatic Castration Resistant Prostate Cancer
Status: Recruiting
Location: See all (17) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
SUMMARY
This is a Phase 1 and Phase 2 study to evaluate the safety and antitumor activity of INV-9956 in adult patients with advanced metastatic Castration Resistant Prostate Cancer.
Eligibility
Participation Requirements
Sex: Male
Minimum Age: 18
Healthy Volunteers: f
View:
• 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 had bilateral orchiectomy.
• Received at least one prior line of taxane-based chemotherapy and at least one line of hormonal AR targeted therapy (eg, abiraterone, enzalutamide). Patients who have refused 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.
Locations
United States
Arizona
Honor Health
RECRUITING
Scottsdale
California
Hoag Family Cancer Institute
NOT_YET_RECRUITING
Newport Beach
UC Irvine Medical Center
RECRUITING
Orange
Texas
Next Oncology - Houston
RECRUITING
Houston
UT Health
RECRUITING
San Antonio
Virginia
NEXT Oncology
RECRUITING
Fairfax
Washington
Summit Cancer Centers
NOT_YET_RECRUITING
Spokane
Other Locations
China
Hu'nan Cancer Hospital
NOT_YET_RECRUITING
Changsha
The First Affiliated Hospital of Fujian Medical University
NOT_YET_RECRUITING
Fuzhou
The First Affiliated Hospital, School of Medicine, Zhejiang University
RECRUITING
Hangzhou
Zhejiang Provincial People's Hospital
NOT_YET_RECRUITING
Hangzhou
Shandong Cancer Hospital
RECRUITING
Ji'nan
Nanjing Drum Tower Hospital
RECRUITING
Nanjing
Fudan University Shanghai Cancer Center
NOT_YET_RECRUITING
Shanghai
Liaoning Cancer Hospital
RECRUITING
Shenyang
Tianjin Medical University Cancer Institute & Hospital