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Phase II clinical study of Utidelone UTD1 in metastatic castration-resistant prostate cancer (mCRPC) after standard treatment failure

Phase II clinical study of Utidelone UTD1 in metastatic castration-resistant prostate cancer (mCRPC) after standard treatment failure

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200061635
Enrollment
Unknown
Registered
2022-06-29
Start date
2022-03-01
Completion date
Unknown
Last updated
2023-04-03

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

Conditions

prostatic cancer

Interventions

one-armed:Utidelone

Sponsors

Cancer Center, Sun Yat-sen University
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. The subjects voluntarily joined the study and signed the informed consent; 2. Aged 18 - 75 years at the date of signature of the informed consent; 3. Patients with histologically or cytologically proven adenocarcinoma of the prostate, excluding small cell carcinoma or other specific types of prostate cancer (non-acinar cell carcinoma); 4. Progression of disease after standard treatment (according to the Prostate Cancer Clinical Trial Working Group 3 criteria), patients must be considered for metastatic castration-resistant prostate cancer (mCRPC) for at least one third-generation antiandrogen (e.g. abiraterone or anthracelul) and docetaxel treatment failure or unsuitable for docetaxel treatment; 5. ECOG score of 0~2; 6. The expected survival >= 3 months.

Exclusion criteria

Exclusion criteria: 1. Had received epomycin within 1 year before administration of the study drug; 2. Severe allergic to epomycin; 3. Patients with grade 3 or above peripheral neurotoxicity during previous chemotherapy; 4. Currently receiving other anti-tumor therapy; 5. Clinically significant mental or central nervous system disorders; 6. Brain metastases with clinical symptoms; 7. Major surgery, or radiotherapy, within 28 days prior to study initiation, or elective surgery required during the study period; 8. Received Chinese herbal or proprietary medicine treatment within 7 days prior to the start of study treatment.

Design outcomes

Primary

MeasureTime frame
PSA remission rate;

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: May 29, 2026