Utidelone Treated for the Recurrent or Metastatic Urothelial Carcinoma

Metastatic Urothelial Carcinoma Clinical Trial

Official title:

Utidelone Treated for the Recurrent or Metastatic Urothelial Carcinoma After Prior Chemotherapy: a Open-label, Multicenter Phase II Study (UTRUST)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05895864
• Other study ID #: SYSKY-2022-515-02
• Status: Recruiting
• Phase: Phase 2
• Start date: June 7, 2023
• Est. completion date: December 13, 2025

Study information

• Verified date: February 2023
• Source: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
• Contact: Herui Yao, MD
• Phone: +86-02034071337
• Email: yaoherui[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 34
• Est. completion date: December 13, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

1. Patients aged 18-70 years

2. Histologically confirmed urothelial carcinoma (pelvis, ureter, bladder, urethra)

3. 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

4. At least one measurable disease according to the response evaluation criteria in solid tumor (RECIST 1.1)

5. Eastern Cooperative Oncology Group (ECOG) performance status between 0 and 2

6. The results of patient's laboratory biochemistry tests are as follows:

• Normal blood routine within 1 week before enrollment (no blood transfusion or hematopoietic stimulating factor therapy within 14 days) :Hemoglobin(Hb) = 90g/L; Neutrophil count (ANC) > 1.5x109 / L; Platelet count (PLT) = 75×109/L

• Renal function: serum creatinine = normal upper limit (ULN)

• Liver and renal function:

Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT)= 3 x ULN, total bilirubin =1.5 x ULN, Serum creatinine :=1.5× ULN or creatinine clearance (Ccr)=50 ml/min

7. Life expectancy = 3 months

8. 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.

9. Females of childbearing potential must have a negative serum pregnancy test at screening and must agree to use double barrier contraception, oral contraceptives, or avoidance of pregnancy measures during the study and for 6 months after the last day of treatment.

Exclusion Criteria:

1. Pregnant or lactating women

2. Suitable for radical means with a chance of cure

3. Patients had received radiation therapy, TKI, or immune checkpoint inhibitor within 2 weeks after the initiation of the study

4. Major organ surgery (excluding needle biopsy) or significant trauma within 4 weeks prior to initial use of the study drug

5. 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;

6. Known active infection with human immunodeficiency virus (HIV), hepatitis B, virus (HBV) or hepatitis C; virus (HCV)

7. Prior allergies to castor oil

8. 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

9. Patients with mental disorders or poor compliance

10. A history of severe cardiovascular and cerebrovascular diseases, including but not limited to severe cardiac rhythm or conduction abnormalities, such as ventricular arrhythmia requiring clinical intervention, degree II-III atrioventricular block, etc. The mean QTcF obtained from three 12-lead ECG examinations at rest was >470ms. Acute coronary syndrome, congestive heart failure, aortic dissection, stroke, or other grade 3 or higher cardiovascular events occurred within 6 months before the first dose of dose. Clinically uncontrolled hypertension

11. Subjects with any other conditions were considered unfit for this study determined by the investigator

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Transitional Cell
• Metastatic Urothelial Carcinoma

Intervention

Drug:
• utidelone injection
utidelone monotherapy in patients with recurrent or metastatic urothelial carcinoma by utidelone

Locations

Country	Name	City	State
China	Sun Yat-sen Memorial Hospital, Sun Yat-sen University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective Response Rate	Reflected by percentage of tumor size reduction or regression, assessed by imaging techniques and expressed as Objective Response Rate (ORR)	24 months
Secondary	Clinical Benefit Rate	CR,PR and SD greater than or equal to 24 weeks	24 weeks
Secondary	Progression Free Survival (PFS)	Time from date of administration of Utidelone to progression or death	24 months
Secondary	Adverse Events and Serious Adverse Events Safety	The incidence of grade =3 adverse reactions and the improvement of quality of life were observed	up to 3 years