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This is a multicenter, open-label, single-arm, phase II study to evaluate the efficacy, safety, and pharmacokinetics of NHWD-870 HCl in adults and adolescents with advanced NUT cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adult:NHWD-870 HCl 2mg ; Adolescent:NHWD-870 HCl 1.5mg/2mg | Experimental | Take a fixed dose of NHWD-870 HCl tablets orally. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NHWD-870 HCl | Drug | Administered P.O. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate (ORR) | Completed at least four weeks of treatment, the curative effect evaluation of CR, PR and maintain at least 4 weeks, the proportion of the subjects,up to 5 months; |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of response (DoR) | Completed at least four weeks of treatment,first time participants from CR or PR to onset of disease (PD),up to 5 months; | |
| Disease control rate (DCR) | Completed at least four weeks of treatment,tumor curative effect evaluation of CR, PR and SD proportion of subjects,up to 5 months; |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chao Deng, Doctor | Contact | +86 023-58103064 | cqsxyyll@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Three Gorges Hospital Affiliated to Chongqing University | Recruiting | Chongqing | 404100 | China |
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| Progression-free survival (PFS) | From start studying drug therapy to the disease progression or any reason for the first time the time of death,up to 12 months; |
| time to remission (TTR) | From the beginning the study drug therapy to ease for the first time (including patients with CR and PR),up to 5 months. |