Utidelone Treated for the Recurrent or Metastatic Urothelial Carcinoma

NCT05895864 | Unknown Phase 2

• 1 other identifier: SYSKY-2022-515-02
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Metastatic Urothelial Carcinoma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Clinical Benefit Rate

  24 weeks

• Progression Free Survival (PFS)

  24 months

• Adverse Events and Serious Adverse Events Safety

  up to 3 years

Study Arms (1)

Utidelone

EXPERIMENTAL

Utidelone Injection: 35 mg/m2/day, IV on day 1-day 5 of each 21 day cycle, administered to enrolled patients with recurrent or metastatic urothelial carcinoma Number of Cycles: until progression or unacceptable toxicity develops or up to 8 cycles.

Drug: utidelone injection

Interventions

utidelone injection DRUG

utidelone monotherapy in patients with recurrent or metastatic urothelial carcinoma by utidelone

Also known as: UTD1 injection

Utidelone

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• 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
• 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.
• 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.

You may not qualify if:

• 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
• Patients with mental disorders or poor compliance
• 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
• Subjects with any other conditions were considered unfit for this study determined by the investigator

Sponsors & Collaborators

• Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University: lead

Study Sites (1)

Sun Yat-sen Memorial Hospital, Sun Yat-sen University

Guangzhou, Guangdong, 510120, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Transitional Cell

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms

Study Officials

• Herui Yao

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

  PRINCIPAL INVESTIGATOR

• Tianxin Lin, MD

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Herui Yao, MD

CONTACT

+86-02034071337; yaoherui@163.com

Tianxin Lin, MD

CONTACT

+86-020-34071337; ltxgcp2017@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Drug: Utidelone

Study Record Dates

• First Submitted: February 19, 2023
• First Posted: June 9, 2023
• Study Start: June 7, 2023
• Primary Completion: December 31, 2024
• Study Completion: December 13, 2025
• Last Updated: June 9, 2023

Record last verified: 2023-02

Locations

CN (1)