Phase I / II, Multicenter Clinical trial to evaluate the safe dose range and confirm the effectiveness and safety of the maximum tolerated dose of Docetaxel In combination with SH003 in patients with solid tumor who are indicated for Docetaxel
- Conditions
- Neoplasms
- Registration Number
- KCT0004770
- Lead Sponsor
- Korea University Anam Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 110
1.Phase 1
1) Adults over 19
2) Patients with histologically and cytologically confirmed lung or breast cancer who failed previous treatment or did not respond to established treatment
3) A person whose previous treatment has terminated at least 4 weeks in advance and do not have persistent toxicity (Grade 1 or higher adverse events according to NCI CTCAE v 5.0) associated with previous treatment (Excluding a grade 2 or less hair loss or sensory neuropathy that is not considered a safety risk to the patient according to the investigator's judgment)
4) Patient whose Eastern Cooperative Oncology Group (ECOG) functional status index is 0-2
5) Patients who have a minimum life expectancy of 12 weeks or more from the expected initial dosing date
6) Person who can swallow pills
7) Patients with measurable lesions based on the RECIST 1.1 scale
8) Proper organ function
i. Bone marrow function : Hb = 8.0 g/dL, ANC = 1,500/?, PLT =100,000/?
ii. Liver Function : bilirubin = 2.5 times the upper limit of normal, AST / ALT = 2.5 times the upper limit of normal (with liver metastasis = 5 times the upper limit of normal)
iii. Kidney function : Serum creatinine = 1.5 times the upper limit or calculated CCr (Cockroft) = 60 ml / min
9) No chance of pregnancy in the case of female.(60 years old or older and have had no menstrual period for more than one year, or have had hysterectomy or bilateral ovarian resection) If there is a possibility of pregnancy, pregnancy test should be performed before participation in the study
10) male and female patients of childbearing age who can follow appropriate contraceptives during the study administration period and for at least eight weeks after discontinuation.
11) Applicants who have fully been explained of the test, the purpose, content, and characteristics of the test drug prior to participation and agreed to participate in the examination at their discretion
12) A person who can understand and follow the instructions and can participate in the whole process of the clinical trial.
2. Phase 2
1)Adults over 19
2) Patients with histologically and cytologically confirmed lung or breast cancer with docetaxel indication
3) Patient with indication of Docetaxel administration
- Patients without Taxane-based Treatment for Metastatic / Recurrent Cancer
- Patient who have a disease-free survival of at least one year after receiving taxane as an adjuvant
- Patients with two or less previous treatments in treatment of metastatic / recurring cancer (Excluding the history of previous hormonal combination therapies based on hormonal receptor-positive cancer
4) A person whose previous treatment has terminated at least 4 weeks in advance and do not have persistent toxicity (Grade 1 or higher adverse events according to NCI CTCAE v 5.0) associated with previous treatment (Excluding a grade 2 or less hair loss or sensory neuropathy that is not considered a safety risk to the patient according to the investigator's judgment)
5) Patient whose Eastern Cooperative Oncology Group (ECOG) functional status index is 0-2
6) Patients who have a minimum life expectancy of 12 weeks or more from the expected initial dosing date
7) Person who can swallow pills
8) Patients with measurable lesions based on the RECIST 1.1 scale
9) Proper organ function
i. Bone marrow function : Hb = 8.0 g/dL, ANC = 1,500/?, PLT =100,000/?
ii. Liver Function : bilirubin = 2.5 times the upper limit of normal, AST / ALT = 2.5 times the upper limit of normal (wi
1) Patients undergoing any topical chemotherapy, including systemic drug therapy or radiation therapy for cancer treatment (Steroid preparations are allowed at or below 10 mg of prednisolone, a physiological maintenance dose, Short-term use of steroids to prevent side effects is allowed, but further systemic steroid therapy is not allowed)
2) Person with known or suspected hypersensitivity or serious adverse events to material, material belonging to same kind(Astragalus, Angelica, Golse root, Cremophor R EL (polyoxyethylated castor oil) or docetaxel
3) Patients with a history of severe hypersensitivity to polysorbate 80
4) Subject with evidence of active infection (HBV, HCV, HIV, TB, etc.) that needs treatment
5) subjects with known past history of positive of immunodeficiency virus (HIV) infection test
6) Patients with Uncontrolled Cardiovascular Disease(patient with symptoms of unstable angina pectoris, heart failure, myocardial infarction, hypertension uncontrolled below 140/90 )
7) Patients with active CMV disease or infection within 4 weeks
8) Patients who have undergone major surgery requiring acute hepatic artery syndrome, cerebrovascular diseases such as stroke, or other assisted breathing devices within one year
9) Patient who is Pregnant or breastfeeding
10) Patient with Metastatic Brain Lesions accompanying Symptoms(Including meninges metastases, patient with no symptoms after previous surgery or radiation surgery and with no recent progress is permitted)
11) Participants in blood donation or other clinical trials of drugs and medical devices within one month prior to the start of the study
12) Organ-transplanted patients, including allogeneic stem-cell transplantation
13) Person who abused of substance which are considered to interfere with research participation and interpretation of research results and have neurological / medical / psychiatric / social diseases
14) Patients with a recent (within last year) severe abnormalities that may increase the risk due to the administration of the investigational drug and participation in the study by the discretion of the researcher, or may interfere with interpretation of the test results
15) Patients who are judged to have lost their ability to consent due to accompanying diseases including dementia
16) Patients with complications of infectious diseases
17) Patients suspected of infectious fever
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Phase 1 clinical trial - safety and tolerability assessment;Phase 2 - Objective Overall Response Rate by RECIST 1.1 criteria or PCWG3 of all cancers
- Secondary Outcome Measures
Name Time Method Phase 2 - Objective Overall Response Rate of each type of cancer;Phase 2 - frequency rate of Peripheral Neuritis and Fatigue among adverse events;Phase 2 - ECOG performance status change;Phase 2 - Progression Free Survival(PFS)