CancerPhase 1/2CH1701NCT04386343
CH1701 for Prevention and Treatment of Radiation Burns
A Phase 1/2 study testing CH1701 for prevention and treatment of radiation burns. and Safety assessment of CH1701 in people with Cancer, run by Vietlife Healthcare Corporation at 1 site in Vietnam.
Trial summary
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 Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Cancer
- What is being tested?
- CH1701 for prevention and treatment of radiation burns. and Safety assessment of CH1701
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 92 participants
- Where
- 1 siteVietnam
- Study dates
- 5 Jul 2019to 1 Dec 2020
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy volunteers, aged 18 and older at the time of enrollment
- Voluntarily participate in the study by signing a consent form to participate in the study
- Ability to adhere to treatment according to researchers' assessment
- Female patient, aged 18 to 60 years old
- Having been diagnosed with breast cancer with axillary lymph node metastasis, having radiation therapy for radiation therapy in the range of 45-50 Gy for a period of 5-6 weeks
- Treatment can be started within 3 days of signing the consent to participate in the study
- Agree to voluntarily sign the consent form to participate in the study
Who cannot join
- 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
- Phase II:
- The available skin lesions in the breast and chest and according to the researchers' judgment will affect the assessment of inflammation caused by radiation
- The patient had radiation therapy before the breast area
- History of connective tissue disorders
- The patient is incapable of complying with the research procedures or is unable to ensure compliance with the study medication as assessed by the researcher
- Participate in other clinical trial studies within 1 month before joining this study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
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
- Conditions
- Cancer
- Being tested
- CH1701 for prevention and treatment of radiation burns., Safety assessment of CH1701, Placebos
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
Safety assessment of CH1701Drug
Safety assessment of CH1701 after 14 days of use on volunteers
PlacebosDrug
The placebo was used on patients as a control for the doses of CH1701
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: Safety assessment of CH1701 |
| 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 Receives: Drug: Safety assessment of CH1701 |
| 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 Receives: Drug: Safety assessment of CH1701 |
| Placebo arm - Phase II | Placebo comparator | 20 Breast cancer patients will use Placebo in the radiation affected area right after radiation Receives: Drug: Placebos |
| 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 Receives: Drug: CH1701 for prevention and treatment of radiation burns. |
| 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 Receives: Drug: CH1701 for prevention and treatment of radiation burns. |
| 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 Receives: Drug: CH1701 for prevention and treatment of radiation burns. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Side effects by skin biopsy
Skin biopsy after 14 days of topical application, compared with healthy skin
Measured: 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
Measured: 63 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2020
- Study start5 Jul 2019
- Primary completionDec 2020 (estimated)
- Study completion1 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 92 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vietlife Healthcare Corporation
- Sponsor type
- Other government
- Collaborators
- Vietnam National Cancer Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04386343
- Sponsor's protocol ID
- CH1701
- Acronym
- CH1701
- Status last verified
- May 2020
- First submitted
- 25 Aug 2019
- Last updated
- 24 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04386343
- Acronym / sponsor ID
- CH1701 / CH1701
- Conditions
- Cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 92 participants (estimated)
- Lead sponsor
- Vietlife Healthcare CorporationOther government
- Collaborators
- Vietnam National Cancer Hospital
- Study start
- 5 Jul 2019 (actual)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- 1 Dec 2020 (estimated)
- First posted
- 13 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 7
- Model description
- 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
| Arm | Type | Receives |
|---|---|---|
| 50% dose level arm - Phase I | Placebo comparator | Drug: Safety assessment of CH17014 healthy volunteer will use 50% dose level for Phase I in the left hand side and use placebo in the right hand side |
| 100% dose level arm - Phase I | Placebo comparator | Drug: Safety assessment of CH17014 healthy volunteer will use 100% dose level for Phase I in the left hand side and use placebo in the right hand side |
| 167% dose level arm - Phase I | Active comparator | Drug: Safety assessment of CH17014 healthy volunteer will use 167% dose level for Phase I in the left hand side and use placebo in the right hand side |
| Placebo arm - Phase II | Placebo comparator | Drug: Placebos20 Breast cancer patients will use Placebo in the radiation affected area right after radiation |
| 50% dose level arm - Phase II | Placebo comparator | Drug: CH1701 for prevention and treatment of radiation burns.20 Breast cancer patients will use CH1701 with 50% of the expected dose level in the radiation affected area right after radiation |
| 100% dose level arm - Phase II | Placebo comparator | Drug: CH1701 for prevention and treatment of radiation burns.20 Breast cancer patients will use CH1701 with 100% of the expected dose level in the radiation affected area right after radiation |
| 167% dose level arm - Phase II | Placebo comparator | Drug: CH1701 for prevention and treatment of radiation burns.20 Breast cancer patients will use CH1701 with 167% of the expected dose level in the radiation affected area right after radiation |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Healthy volunteers, aged 18 and older at the time of enrollment
- Voluntarily participate in the study by signing a consent form to participate in the study
- Ability to adhere to treatment according to researchers' assessment
- Female patient, aged 18 to 60 years old
- Having been diagnosed with breast cancer with axillary lymph node metastasis, having radiation therapy for radiation therapy in the range of 45-50 Gy for a period of 5-6 weeks
Key exclusion criteria (8 listed)
- 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
- The available skin lesions in the breast and chest and according to the researchers' judgment will affect the assessment of inflammation caused by radiation
- The patient had radiation therapy before the breast area
- History of connective tissue disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CH1701 for prevention and treatment of radiation burns.Ch1701 is used for cancer patients who are treated with radiotherapy, then assess the safety and treatment effectiveness of the product. | Drug | 100% dose level arm - Phase II, 167% dose level arm - Phase II, 50% dose level arm - Phase II |
| Safety assessment of CH1701Safety assessment of CH1701 after 14 days of use on volunteers | Drug | 100% dose level arm - Phase I, 167% dose level arm - Phase I, 50% dose level arm - Phase I |
| PlacebosThe placebo was used on patients as a control for the doses of CH1701 | Drug | Placebo arm - Phase II |
Primary outcome
Side effects by skin biopsy
Time frame: 14 days
Skin biopsy after 14 days of topical application, compared with healthy skin
Degree of burns according to CTCAE 4.03 atlas
Time frame: 63 days
Take photograph of skin every week comparing with atlas CTCAE 4.03 to determine the degree of burns
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2020.
- Individual participant dataSharing planned: Undecided
Related trials for Cancer
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
RecruitingPhase 2
Tafasitamab With Acalabrutinib and Venetoclax for the Treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Chronic Lymphocytic Leukemia, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Active, not recruitingPhase 1/2
Selumetinib in Treating Young Patients With Recurrent or Refractory Low Grade Glioma
Low Grade Glioma, Recurrent Childhood Pilocytic Astrocytoma
Enrolling by invitationPhase 2
A Single-Arm Study of Nimotuzumab Combined With NALIRIFOX as First-Line Treatment for Pancreatic Cancer
Pancreatic Cancer Metastatic
Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing CH1701 for prevention and treatment of radiation burns. and Safety assessment of CH1701 in people with Cancer, run by Vietlife Healthcare Corporation at 1 site in Vietnam.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Side effects by skin biopsy (time frame: 14 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2020.