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The goal of this clinical trial is to evaluate the efficacy and safety of WX390 in patients with advanced solid tumors. The main questions it aims to answer are:
This study will be an open-label, multicenter phase II clinical trial. After being informed about the study and potential risks, all patients giving written informed consent will undergo a 4-week screening period to determine eligibility for study entry. And then patents will be administered for 12 cycles treatment and 30 days safety follow up after the last dose of treatment. The efficacy and safety measures will be conducted and collected every cycle.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| WX390 | Experimental | Participants will receive WX390 continuous oral dosing (1.1 mg once a day). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| WX390 | Drug | WX390 tablet, 1.1 mg once a day |
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| Measure | Description | Time Frame |
|---|---|---|
| Progression-Free Survival (PFS) | PFS, time from the first dose of trial medication to the first occurrence of disease progression or death due to any cause on study, whichever occurs first. | Week 48 |
| Overall Survival (OS) | OS, time from first dose of trial medication to death due to any cause. | Week 48 |
| Duration of Response (DOR) | DoR, the time from the first occurrence of objective response until disease progression or death from any cause, whichever occurs first. | Week 48 |
| Progression-free survival rate (PFSR) | PFSR, Percentage of patients alive without progression from baseline. | Week 24 and Week 48 |
| Objective Response Rate (ORR) | ORR, proportion of patients with complete response (CR) or partial response (PR). | Week 24 and Week 48 |
| Disease control rate (DCR) | DCR, proportion of patients with CR or PR or SD. | Week 24 and Week 48 |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence, nature, and severity of adverse events (AEs) | Incidence, nature, and severity of adverse events (AEs) refer to the frequency, type, and level of harm of undesirable effects in clinical trials. Incidence shows how often AEs occur. Nature describes the specific characteristics of AEs, while severity indicates the extent of harm caused. | Week 24 and Week 48 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jiajia Li | Contact | 008621-64175590 | doc_lijiajia@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Xiaohua Wu, PhD | Fudan University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fudan University Shanghai Cancer Center | Recruiting | Shanghai | Shanghai Municipality | 200000 | China |
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