Metastatic Urothelial CarcinomaPhase 2NCT05895864
Utidelone Treated for the Recurrent or Metastatic Urothelial Carcinoma
A Phase 2 study testing utidelone injection in people with Metastatic Urothelial Carcinoma, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Metastatic Urothelial Carcinoma
- What is being tested?
- utidelone injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteChina
- Study dates
- 7 Jun 2023to 13 Dec 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
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- 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.
Who cannot join
- 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)
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- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, Guangdong, 510120
Tao Qin, MD, +86-020-34071337, qintao5471@163.com
Tao Qin, MD
About this study
Official title: 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.
- Conditions
- Metastatic Urothelial Carcinoma
- Being tested
- utidelone injection
- Medical subject headings
- Carcinoma, Transitional Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
utidelone injectionDrug
Also called UTD1 injection
utidelone monotherapy in patients with recurrent or metastatic urothelial carcinoma by utidelone
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: utidelone injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate
Reflected by percentage of tumor size reduction or regression, assessed by imaging techniques and expressed as Objective Response Rate (ORR）
Measured: 24 months
Secondary outcomes (3)
Clinical Benefit Rate
CR,PR and SD greater than or equal to 24 weeks
Measured: 24 weeks
Progression Free Survival (PFS)
Time from date of administration of Utidelone to progression or death
Measured: 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
Measured: up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2023
- Study start7 Jun 2023 (estimated)
- Primary completion31 Dec 2024 (estimated)
- Study completion13 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Urothelial CarcinomaStudies of the same condition, open and under way.
- More trials run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Drug: Utidelone
- Masking
- None (open label)
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Herui Yao, Principal investigator, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityTianxin Lin, MD, Principal investigator, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05895864
- Sponsor's protocol ID
- SYSKY-2022-515-02
- Status last verified
- Feb 2023
- First submitted
- 19 Feb 2023
- Last updated
- 9 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Utidelone Treated for the Recurrent or Metastatic Urothelial Carcinoma After Prior Chemotherapy: a Open-label, Multicenter Phase II Study (UTRUST)
- ClinicalTrials.gov ID
- NCT05895864
- Acronym / sponsor ID
- SYSKY-2022-515-02
- Conditions
- Metastatic Urothelial Carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- 7 Jun 2023 (estimated)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 13 Dec 2025 (estimated)
- First posted
- 9 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Drug: Utidelone
| Arm | Type | Receives |
|---|---|---|
| Utidelone | Experimental | Drug: utidelone injectionUtidelone 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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
Key exclusion criteria (11 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| utidelone injectionAlso: UTD1 injectionutidelone monotherapy in patients with recurrent or metastatic urothelial carcinoma by utidelone | Drug | Utidelone |
Primary outcome
Objective Response Rate
Time frame: 24 months
Reflected by percentage of tumor size reduction or regression, assessed by imaging techniques and expressed as Objective Response Rate (ORR）
3 secondary outcomes
Clinical Benefit Rate
Time frame: 24 weeks
Progression Free Survival (PFS)
Time frame: 24 months
Adverse Events and Serious Adverse Events Safety
Time frame: up to 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Herui Yao principal investigator
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Tianxin Lin, MD principal investigator
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing utidelone injection in people with Metastatic Urothelial Carcinoma, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Herui Yao, MD (+86-02034071337, yaoherui@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2023.