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A Phase I study of SH003 for evaluate safe dose range in patients with solid cancer.
The first dose group receives SH003 for 3 weeks. If the adverse events occur in less than one in six participants, the dose is escalated.
The second dose group receives SH003 for 3 weeks. If the adverse events occur in less than one in six participants, the dose is escalated.
The third dose group receives SH003 for 3 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SH003 | Experimental | Participant will take SH003 for 3 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SH003 | Drug | Herbal medicine for cancer treatment |
|
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events | Grade 3-4 adverse event using CTCAE v4.03 | 3 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ajou University Hospital | Suwon | 16499 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32186413 | Derived | Cheon C, Ko SG. A Phase I Study to Evaluate the Safety of the Herbal Medicine SH003 in Patients With Solid Cancer. Integr Cancer Ther. 2020 Jan-Dec;19:1534735420911442. doi: 10.1177/1534735420911442. | |
| 30082340 | Derived | Cheon C, Kang S, Ko Y, Kim M, Jang BH, Shin YC, Ko SG. Single-arm, open-label, dose-escalation phase I study to evaluate the safety of a herbal medicine SH003 in patients with solid cancer: a study protocol. BMJ Open. 2018 Aug 5;8(8):e019502. doi: 10.1136/bmjopen-2017-019502. |
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