Solid TumorPhase 1NCT04360317
Safety of the Combination of SH003 and Docetaxel in Patients With Solid Cancer
A Phase 1 study testing Combination of SH003 and Docetaxel in people with Solid Tumor, run by Kyunghee University Medical Center.
Trial summary
The study is designed as a single Group, Dose Elevating trial which evaluates safety to confirm the final maximum tolerated dose by the combination of oral administration of SH003 to docetaxel administered patients. Firstly, 3 subjects is recruited and administered for 21 days for the starting dose of 2,400 mg / day. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Solid Tumor
- What is being tested?
- Combination of SH003 and Docetaxel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- No sites listed yet
- Study dates
- Jun 2020to Aug 2021
- Phase
- Phase 1
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged above 19 years
- Patients with histologically or cytologically confirmed lung cancer or breast cancer for which standard curative measures do not exist or are no longer effective
- Patients who have not received chemotherapy, radiotherapy or surgery within the last 4 weeks and no residual toxicity associated with the previous treatment (Grade 1 or higher adverse event according to Common Terminology Criteria for Adverse Events (CTCAE) ver 5.0 from the National Cancer Institute (NCI)
- ECOG Performance Status ≤ 2
- Life expectancy estimated to be at least 12 weeks
- Patients with the ability to swallow tablets
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- Patients with measurable lesions according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
- Patients with proper organ function as follows i. Bone marrow function: haemoglobin ≥8 g/dL, absolute neutrophil count ≥1,500/uL, and platelets ≥ 100,000/uL ii. Liver function: total bilirubin, aspartate aminotransferase (AST), or alanine aminotransferase (ALT) ≤ 2.5 times the upper limit of normal (ULN) (if patients with liver metastasis, ≤ 5 times the ULN) iii. Renal function: Serum creatinine ≤ 1.5 times the ULN or creatinine clearance according to the Cockroft-Gault equation ≥ 60 ml/min
- No possibility of pregnancy if the participant is female (over 60 years of age, without menstruation for more than one year, or underwent hysterectomy or bilateral oophorectomy). If there is a possibility of pregnancy, pregnancy test should be conducted prior to participation in the study to prove that it is not pregnancy
- Patients who agree to use effective means of contraception during the trial and up to 8 weeks after final administration
- Patients with the ability to understand the study and who are willing to sign a written informed consent document
Who cannot join
- Patients undergoing any systemic therapy or regional therapy including radiotherapy, for the purpose of treating cancer
- Participants with known hypersensitivity to any study drug component, including Astragalus membranaceus, Angelica gigas, Trichosanthes Kirilowii Maximowicz, and polysorbate 80
- Patients with active infections requiring treatment (active hepatitis A, B, and C viruses, human immunodeficiency virus, tuberculosis)
- Patients with history of human immunodeficiency virus infection
- Patients with uncontrolled cardiovascular diseases (unstable angina, heart failure, myocardial infarction, hypertension that remains uncontrolled: 140/90 mm Hg or higher)
- Patients with active cytomegalovirus infection within the past 4 weeks
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- Patients who have experienced major surgery on cerebrovascular disease such as acute coronary syndrome, stroke, etc., within the past year
- pregnant or lactating females
- Patient with metastatic encephalopathy with symptoms
- Patients who have donated blood or participated in other clinical trials of medicine or medical devices within the past month
- Patient underwent organ transplantation including allogenic stem cell transplantation
- Patients with complications of infectious diseases
- Patients with suspected fever caused by infection
- Patients with substance abuse or any neurological, medical, psychological, or sociological conditions that could potentially interfere with their compliance to the study protocol or interpretation of study results
- Patients who are judged inappropriate for the study by investigator
- Patients who are judged to have lost their ability to consent due to accompanying disease such as dementia
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Phase I Study to Evaluate the Maximum Tolerated Dose of the Combination of SH003 and Docetaxel in Patients With Solid Cancer
The study is designed as a single Group, Dose Elevating trial which evaluates safety to confirm the final maximum tolerated dose by the combination of oral administration of SH003 to docetaxel administered patients.
Firstly, 3 subjects is recruited and administered for 21 days for the starting dose of 2,400 mg / day. If no DLT occurs, raise the dose to a secondary dose of 3,600 mg / day. If DLT occurs, additional 3 subjects are recruited and administered for 2,400mg / day. After, If two or more of the six subjects shows DLT, stop the capacity increase, whereas if DLT occurs in less than 1 person, increase the dose to 3,600 mg / day. Next, 3 subjects is recruited and administered for 21 days for a dose of 3,600 mg / day. If no DLT occurs, raise the dose to 4,800 mg / day. If DLT occurs, 3 subjects are additionally recruited and administered for 3,600 mg / day. After, If two or more of the six subjects shows DLT, stop the capacity increase, whereas if DLT occurs in less than 1 person, increase the dose to 4,800 mg / day. Finally, 3 subjects is recruited and administered for a dose of 4,800 mg / day. If no DLT occurs, complete the study. If DLT occurs, additional 3 subjects are recruited and administered for 4,800mg / day and complete the study after observation.
- Conditions
- Solid Tumor
- Being tested
- Combination of SH003 and Docetaxel
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combination of SH003 and DocetaxelDrug
Combination of SH003 and Docetaxel
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Not described Receives: Drug: Combination of SH003 and Docetaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose limiting toxicity
adverse event according to CTCAE
Measured: up to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2020
- Study startJun 2020 (estimated)
- Primary completionMay 2021 (estimated)
- Study completionAug 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Solid TumorStudies 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kyunghee University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Seong-Gyu Ko, Kyunghee University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04360317
- Sponsor's protocol ID
- ISEE_2018_SH003
- Status last verified
- Apr 2020
- First submitted
- 20 Apr 2020
- Last updated
- 24 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cheon C, Ko SG. Phase I study to evaluate the maximum tolerated dose of the combination of SH003 and docetaxel in patients with solid cancer: A study protocol. Medicine (Baltimore). 2020 Sep 18;99(38):e22228. doi: 10.1097/MD.0000000000022228.
PubMed 32957363
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Study to Evaluate the Maximum Tolerated Dose of the Combination of SH003 and Docetaxel in Patients With Solid Cancer
- ClinicalTrials.gov ID
- NCT04360317
- Acronym / sponsor ID
- ISEE_2018_SH003
- Conditions
- Solid Tumor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 9 participants (estimated)
- Lead sponsor
- Kyunghee University Medical CenterUniversity, hospital or other
- Study start
- Jun 2020 (estimated)
- Primary completion
- May 2021 (estimated)
- Study completion
- Aug 2021 (estimated)
- First posted
- 24 Apr 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.
The study is designed as a single Group, Dose Elevating trial which evaluates safety to confirm the final maximum tolerated dose by the combination of oral administration of SH003 to docetaxel administered patients.
Firstly, 3 subjects is recruited and administered for 21 days for the starting dose of 2,400 mg / day. If no DLT occurs, raise the dose to a secondary dose of 3,600 mg / day. If DLT occurs, additional 3 subjects are recruited and administered for 2,400mg / day. After, If two or more of the six subjects shows DLT, stop the capacity increase, whereas if DLT occurs in less than 1 person, increase the dose to 3,600 mg / day. Next, 3 subjects is recruited and administered for 21 days for a dose of 3,600 mg / day. If no DLT occurs, raise the dose to 4,800 mg / day. If DLT occurs, 3 subjects are additionally recruited and administered for 3,600 mg / day. After, If two or more of the six subjects shows DLT, stop the capacity increase, whereas if DLT occurs in less than 1 person, increase the dose to 4,800 mg / day. Finally, 3 subjects is recruited and administered for a dose of 4,800 mg / day. If no DLT occurs, complete the study. If DLT occurs, additional 3 subjects are recruited and administered for 4,800mg / day and complete the study after observation.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Drug: Combination of SH003 and Docetaxel |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Patients aged above 19 years
- Patients with histologically or cytologically confirmed lung cancer or breast cancer for which standard curative measures do not exist or are no longer effective
- Patients who have not received chemotherapy, radiotherapy or surgery within the last 4 weeks and no residual toxicity associated with the previous treatment (Grade 1 or higher adverse event according to Common Terminology Criteria for Adverse Events (CTCAE) ver 5.0 from the National Cancer Institute (NCI)
- ECOG Performance Status ≤ 2
- Life expectancy estimated to be at least 12 weeks
Key exclusion criteria (16 listed)
- Patients undergoing any systemic therapy or regional therapy including radiotherapy, for the purpose of treating cancer
- Participants with known hypersensitivity to any study drug component, including Astragalus membranaceus, Angelica gigas, Trichosanthes Kirilowii Maximowicz, and polysorbate 80
- Patients with active infections requiring treatment (active hepatitis A, B, and C viruses, human immunodeficiency virus, tuberculosis)
- Patients with history of human immunodeficiency virus infection
- Patients with uncontrolled cardiovascular diseases (unstable angina, heart failure, myocardial infarction, hypertension that remains uncontrolled: 140/90 mm Hg or higher)
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 |
|---|---|---|
| Combination of SH003 and DocetaxelCombination of SH003 and Docetaxel | Drug | Experimental group |
Primary outcome
Dose limiting toxicity
Time frame: up to 4 weeks
adverse event according to CTCAE
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2020.
- Derived from this study: PubMed 32957363Cheon C, Ko SG. Phase I study to evaluate the maximum tolerated dose of the combination of SH003 and docetaxel in patients with solid cancer: A study protocol. Medicine (Baltimore). 2020 Sep 18;99(38):e22228. doi: 10.1097/MD.0000000000022228.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Combination of SH003 and Docetaxel in people with Solid Tumor, run by Kyunghee University Medical Center.
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 11 inclusion and 16 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 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this 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.
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?
Contact Chunhoo Cheon, Dr. (8229619278, hreedom35@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose limiting toxicity (time frame: up to 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04360317, which also lists 1 linked publication.
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 Apr 2020.