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Safety and efficacy of histone deacetylase inhibitors (chidamide) in combination with abiraterone in the treatment of metastatic castration-resistant prostate cancer (mCRPC): a single-arm, open phase, Ib clinical study study

Safety and efficacy of histone deacetylase inhibitors (chidamide) in combination with abiraterone in the treatment of metastatic castration-resistant prostate cancer (mCRPC): a single-arm, open phase, Ib clinical study study

Status
Recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200058569
Enrollment
Unknown
Registered
2022-04-11
Start date
2021-08-01
Completion date
Unknown
Last updated
2024-01-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

prostatic cancer

Interventions

Experimental group 3:Citabenamine (30mg) in combination with abiraterone
Experimental group 1:Citabenamine (20mg) in combination with abiraterone
Experimental group 2:Citabenamine (25mg) in combination with abiraterone

Sponsors

Sun Yat-sen University Cancer Center
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Aged >=18 years and =3 months.

Exclusion criteria

Exclusion criteria: 1. Treatment with histone deacetylase inhibitors within 1 year prior to drug administration. 2. Severe allergy to histone deacetylase inhibitors. 3. Those currently receiving other antitumor therapies. 4. Patients with clinically significant mental or central nervous system diseases. 5. Patients with clinical symptoms of brain metastases. 6. Major surgery within 28 days prior to the start of the study, or radiation therapy within 90 days prior. 7. Received Chinese herbal or proprietary medicine treatment within 7 days before starting the study treatment.

Design outcomes

Primary

MeasureTime frame
maximum tolerated dose;dose-limiting toxicities;recommended phase ? dose;adverse event, AE;—

Countries

China

Contacts

Public ContactShi Yanxia

Cancer Center, Sun Yat-sen University

shiyx@sysucc.org.cn+86 13609058827

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026