Utidelone Treated for the Recurrent or Metastatic Urothelial Carcinoma

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

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.

Study Overview

• Status: Recruiting
• Conditions: Metastatic Urothelial Carcinoma
• Intervention / Treatment: Drug: utidelone injection

• Study Type: Interventional
• Enrollment (Estimated): 34
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Herui Yao, MD; Phone Number: +86-02034071337; Email: yaoherui@163.com
• Study Contact Backup: Name: Tianxin Lin, MD; Phone Number: +86-020-34071337; Email: ltxgcp2017@163.com

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510120
      • Recruiting
      • Sun Yat-sen Memorial Hospital, Sun Yat-sen University
      • Contact: Tao Qin, MD; Phone Number: +86-020-34071337; Email: qintao5471@163.com
      • Sub-Investigator: Tao Qin, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Utidelone; 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; utidelone monotherapy in patients with recurrent or metastatic urothelial carcinoma by utidelone; Other Names: UTD1 injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical Benefit Rate	CR,PR and SD greater than or equal to 24 weeks	24 weeks
Progression Free Survival (PFS)	Time from date of administration of Utidelone to progression or death	24 months
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

Collaborators and Investigators

• Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
• Investigators: Principal Investigator: Tianxin Lin, MD, Sun Yat-sen Memorial Hospital，Sun Yat-sen University; Principal Investigator: Herui Yao, Sun Yat-sen Memorial Hospital，Sun Yat-sen University

Study record dates

Study Major Dates

• Study Start (Estimated): June 7, 2023
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 13, 2025

Study Registration Dates

• First Submitted: February 19, 2023
• First Submitted That Met QC Criteria: May 29, 2023
• First Posted (Actual): June 9, 2023

Study Record Updates

• Last Update Posted (Actual): June 9, 2023
• Last Update Submitted That Met QC Criteria: May 29, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Carcinoma; Carcinoma, Transitional Cell
• Other Study ID Numbers: SYSKY-2022-515-02

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No