KCT0004770
Not yet recruiting
未知
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
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Korea University Anam Hospital
- Enrollment
- 110
- Status
- Not yet recruiting
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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)
Exclusion Criteria
- •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)
Outcomes
Primary Outcomes
Not specified
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