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| Name | Class |
|---|---|
| Vietnam National Cancer Hospital | INDIV |
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A combined Phase I&II, randomized, double-blind, placebo-controlled clinical trial to evaluate efficacy and safety for prevention and treatment of radiation therapy burn of CH1701
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 50% dose level arm - Phase I | Placebo Comparator | 4 healthy volunteer will use 50% dose level for Phase I in the left hand side and use placebo in the right hand side |
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| 100% dose level arm - Phase I | Placebo Comparator | 4 healthy volunteer will use 100% dose level for Phase I in the left hand side and use placebo in the right hand side |
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| 167% dose level arm - Phase I | Active Comparator | 4 healthy volunteer will use 167% dose level for Phase I in the left hand side and use placebo in the right hand side |
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| Placebo arm - Phase II | Placebo Comparator | 20 Breast cancer patients will use Placebo in the radiation affected area right after radiation |
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| 50% dose level arm - Phase II | Placebo Comparator | 20 Breast cancer patients will use CH1701 with 50% of the expected dose level in the radiation affected area right after radiation |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CH1701 for prevention and treatment of radiation burns. | Drug | Ch1701 is used for cancer patients who are treated with radiotherapy, then assess the safety and treatment effectiveness of the product. |
| Measure | Description | Time Frame |
|---|---|---|
| Side effects by skin biopsy | Skin biopsy after 14 days of topical application, compared with healthy skin | 14 days |
| Degree of burns according to CTCAE 4.03 atlas | Take photograph of skin every week comparing with atlas CTCAE 4.03 to determine the degree of burns | 63 days |
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*Phase I:
Inclusion Criteria:
Exclusion Criteria:
Subjects with other acute or chronic diseases need to be treated
It is not possible to comply with the research or studied drug treatment process in the opinion of the researcher
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vietlife Healthcare Corporation | Hanoi | Vietnam |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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Phase I: Three dose level - 50%, 100% and 167% of the expected dose level Phase II: Four dose level - 0% (Placebo), 50%, 100% and 167% of the expected dose level
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Participants and investigator are blinded to the treatment
| 100% dose level arm - Phase II | Placebo Comparator | 20 Breast cancer patients will use CH1701 with 100% of the expected dose level in the radiation affected area right after radiation |
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| 167% dose level arm - Phase II | Placebo Comparator | 20 Breast cancer patients will use CH1701 with 167% of the expected dose level in the radiation affected area right after radiation |
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| Safety assessment of CH1701 | Drug | Safety assessment of CH1701 after 14 days of use on volunteers |
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| Placebos | Drug | The placebo was used on patients as a control for the doses of CH1701 |
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