UnknownPhase 2

Utidelone Treated for the Recurrent or Metastatic Urothelial Carcinoma

China34 participantsStarted 2023-06-07

Plain-language summary

This study is a open-label, multicenter, phase II study to evaluate the efficacy and safety of utidelone in the recurrent or metastatic urothelial carcinoma after prior chemotherapy.

Who can participate

Age range18 Years – 70 Years

SexALL

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Inclusion criteria

✓. Patients aged 18-70 years
✓. Histologically confirmed urothelial carcinoma (pelvis, ureter, bladder, urethra)
✓. Recurrent (unresectable) or metastatic urothelial carcinoma, Patients with primary urothelial carcinoma, mixed with other tissue components, failed or intolerant to standard treatment, and failed to receive neoadjuvant chemotherapy combined with immunotherapy for 12 months were allowed
✓. At least one measurable disease according to the response evaluation criteria in solid tumor (RECIST 1.1)
✓. Eastern Cooperative Oncology Group (ECOG) performance status between 0 and 2
✓. The results of patient's laboratory biochemistry tests are as follows:
✓. Life expectancy ≥ 3 months
✓. Male or female patients of child-producing potential must agree to use double barrier contraception, oral contraceptives, or avoidance of pregnancy measures during the study and for 3 months after the last day of treatment.

Exclusion criteria

✕. Pregnant or lactating women
✕. Suitable for radical means with a chance of cure
✕. Patients had received radiation therapy, TKI, or immune checkpoint inhibitor within 2 weeks after the initiation of the study
✕. Major organ surgery (excluding needle biopsy) or significant trauma within 4 weeks prior to initial use of the study drug
✕. Received an investigational agent, chemotherapy, biological therapy, hormonal therapy, targeted therapy, or radiotherapy within 30 days prior to commencing study treatment, or have not recovered from all treatment-related toxicities to Common Toxicity Criteria (CTC) Grade less than or equal to 1, except for alopecia.CTCAE v.5.0 Grade greater than or equal to 2 peripheral neuropathy;
✕. Known active infection with human immunodeficiency virus (HIV), hepatitis B, virus (HBV) or hepatitis C; virus (HCV)
✕. Prior allergies to castor oil
✕. Patients with symptomatic central nervous system metastases are not permitted, except for those with stable and asymptomatic brain metastases who have completed cranial irradiation, and have at least one measurable lesion outside the brain. Radiotherapy should be completed within 4 weeks prior to the registration

What they're measuring

Objective Response Rate

Timeframe: 24 months

Trial details

NCT IDNCT05895864

SponsorSun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-12-31

Contact for this trial

Herui Yao, MD

+86-02034071337 yaoherui@163.com

View on ClinicalTrials.gov More Metastatic Urothelial Carcinoma trials