Status:
UNKNOWN
Safety of the Combination of SH003 and Docetaxel in Patients With Solid Cancer
Lead Sponsor:
Kyunghee University Medical Center
Conditions:
Solid Tumor
Eligibility:
All Genders
19+ years
Phase:
PHASE1
Brief 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 adminis...
Eligibility Criteria
Inclusion
- 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
- 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
Exclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2021
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT04360317
Start Date
June 1 2020
End Date
August 1 2021
Last Update
April 24 2020
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