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Phase 1 Study of ACE-232 to Treat Patients With Metastatic Castration-Resistant Prostate Cancer

RecruitingPhase 1Ages 18 Years - anyMaleAcerand Therapeutics (Hong Kong) Limited
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In plain words

What the trial is, and whether it could suit you

This is an open label, phase I, multi-center study aiming to assess the safety and tolerability in patients with metastatic castration resistant prostate cancer (mCRPC).

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
Inclusion Criteria: * Provide written informed consent * Metastatic Castration-resistant Prostate Cancer with ongoing androgen - deprivation therapy (ADT) or have bilateral orchiectomy * Difficult to treat or intolerant to standard treatment (post at least 1 line of NHA and taxane-based chemo in mHSPC or mCRPC), suitable for investigational treatment; * Has Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 * Has a life expectancy of at least 6 months * Adequate organ function and bone marrow function Exclusion Criteria: * Receiving any anti-cancer drugs or other treatment, major surgery, extensive radiation therapy, or local radiation therapy within protocol-defined wash-out period; * Concomitant use of medications or herbal supplements known to be moderate to strong CYP3A4 inhibitors/inducers, or P-gp inhibitors, known to prolong the QT interval. * Any previous treatment-related toxicities have not recovered. * Spinal cord compression or known brain metastases or leptomeningeal carcinomatosis. * Severe cardiovascular disorders. * Known gastrointestinal (GI) disorder or GI procedure * History of gastric and duodenal perforation. * History of pituitary dysfunction. * Poorly controlled diabetes mellitus. * Active or uncontrolled autoimmune disease * Active infections, or a known history of HIV infection, or a known active hepatitis B or C, or a known active tuberculosis. * Other malignancies requiring treatment within 3 years prior to the first dose of study drug * Known allergy or hypersensitivity to any of the excipients of ACE-232. * Has other medical conditions that at the discretion of the investigator interfere with safety or efficacy evaluation, or treatment compliance.
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What it tests

  • ACE-232 tablets
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Where

13 sites
University of California San Diego, Moores Cancer Center
La Jolla, United States
Moffitt Cancer Center, Tampa
Tampa, United States
University of Maryland, Greenebaum Comprehensive Cancer Center
Baltimore, United States
Harvard Medical School-Massachusetts General Hospital
Boston, United States
M Health Fairview Clinics and Surgery Center
Minneapolis, United States
Xcancer (Urology Cancer Center)
Omaha, United States
Carolina Urologic Research Center
Myrtle Beach, United States
Fred Hutchinson Cancer Research Center
Seattle, United States

…and 5 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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