A study of DHP107, a novel oral paclitaxel formulation, to determine maximum tolerated dose
and recommended dose for phase II trial in patients with advanced solid cancer and explore
efficacy of DHP107 in patients with gastric cancer
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Full eligibility criteria for NCT02890511
Ages eligible for Study
18 Years to 70 Years
Genders eligible for Study
Accepts Healthy Volunteers
Patients between 18 and 70 years old
Patients prognosed with advanced or metastatic solid cancer by histopathology or cytology analysis who have no available standard therapy or who have failed at least once with the standard therapy
Adequate bone marrow function, liver function and adequate kidney function
Eastern Cooperative Oncology Group performance status ≤ 2
Life expectancy of 3 month or more
Written informed consent
Major infectious or neurological disease and bowel obstruction
Brain metastasis or hematologic malignancy
Patients who underwent surgery, radiation therapy, hormone or chemotherapy within 4 weeks prior to the beginning of investigational drug administration
Patients with the history of failure to the taxane line of chemotherapy (with the exception of when it was used before 6 month as adjuvant therapy or when the treatment was discontinued due to docetaxel related side effect)
Patients who are required to continuously take P-gp (P-glycoprotein) suppressor, immune suppressor, proton-pump inhibitor or H2-receptor antagonist during clinical trial period
Patients deemed by the investigator to suffer from severe heart disease (myocardial infarction, congestive heart failure, arrythmia accompanying drastic changes on ECG, severe or unstable angina pectoris, or other severe heart disease) or accompanying other severe internal diseases (such as uncontrollable diabetes, chronic obstructive pulmonary disease)
Patients with prior history of participating in a clinical trial within 30 days from registration for current clinical trial
Patient with history of alcohol or drug abuse in the recent 3 months
Pregnant women, nursing mothers, or patients of childbearing age who did not agree to contraception (both men and women)
Patients with (or suspected to have) abnormality in bile acid secretion (e.g.,. patients with resected gallbladder)
Patients who had a history of serious gastrointestinal bleeding, or with diseases that could affect the absorption of oral medication (malabsorption syndrome, active peptic ulcer)
Patients with history of severe hypersensitive reaction to active ingredient and excipient of the investigational drug
Patient who are in a state that is deemed inappropriate to participate in the clinical trial by the investigator
All locations for NCT02890511
Korea, Republic of (1)
Asan Medical Center
Seoul, Korea, Republic of, 138-736
View full eligibility
Tris trial is registered with FDA with number: NCT02890511. The sponsor of the trial is Daehwa Pharmaceutical Co., Ltd. and it is looking for 28 volunteers for the current phase.
Official trial title: A Study of DHP107, a Novel Oral Paclitaxel Formulation, to Determine Maximum Tolerated Dose and Recommended Dose for Phase II Trial in Patients With Advanced Solid Cancer
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