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| Name | Class |
|---|---|
| Chengdu Biostar Pharmaceuticals | INDUSTRY |
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To assess the effectiveness and safety of utidelone injection in patients with advanced or metastatic NSCLC as a phase II trial
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| utidelone | Experimental | Utidelone Injection: 30 mg/m2/day, IV on day 1-day 5 of each 21 day cycle, administered to enrolled patients with advanced NSCLC |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| utidelone injection | Drug | utidelone monotherapy in patients with advanced NSCLC by utidelone |
|
| Measure | Description | Time Frame |
|---|---|---|
| Tumor response to utidelone treatment | Reflected by percentage of tumor size reduction or regression, assessed by imaging techniques and expressed as Objective Response Rate (ORR)ORR is defined as the proportion of patients with a best overall response of Complete Response (CR) or Partial Response (PR) according to RECIST. 1.1. | 6 months from first study treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Progression free survival (PFS) | PFS is defined as the duration of time from first study treatment to disease progression or death from any cause as documented by the investigator | 1 year from first study treatment |
| Overall survival (OS) |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| YUANKAI SHI, MD, PhD | National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences, Beijing, China | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cancer Hospital, Chinese Academy of Medical Sciences | Beijing | Beijing Municipality | 100021 | China | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38601485 | Derived | Shi Y, Chen G, Zhao Y, Zhao J, Lin L. Efficacy and safety of utidelone for the treatment of patients with locally advanced or metastatic non-small-cell lung cancer who have failed standard second-line treatment: A phase 2 clinical trial (BG01-1801). Cancer Pathog Ther. 2023 Oct 29;2(2):103-111. doi: 10.1016/j.cpt.2023.10.006. eCollection 2024 Apr. |
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OS is defined as the duration of time from first study treatment until death from any cause.
| 2 year from enrolment |
| Incidence of treatment-emergent adverse events based the Common Terminology Criteria for Adverse Events (CTCAE) version 4·03 | Observe and record incidence of adverse events and severe adverse events associated with utidelone treatment, assessed by investigators according to CTCAE version 4·03 | 1 year from first study treatment |
| Peking Union Hospital |
| Beijing |
| Beijing Municipality |
| China |
| Harbin Medical University Cancer Hospital | Harbin | Heilongjiang | 150081 | China |
| Tianjin People's Hospital | Tianjin | Tianjin Municipality | China |