Advanced Metastatic Gastric Cancer, Recurrent Gastric Cancer
Conditions
Keywords
Oraxol®, oral paclitaxel, paclitaxel, HM30181A, MTD, DLT, RD
Brief summary
The main objectives of this study are to determine the maximum tolerated dose (MTD) and recommend dose (RD) of Oraxol® in Phase I and to determine the objective response rate of Oraxol® in Phase II.
Detailed description
Administration Schedule: 1 cycle of Oraxol® is 28 days and Oraxol® is administrated twice a week, total 6 times per cycle (day 1,2,8,9,15 and 16).
Interventions
DRUGPaclitaxel
HM30181AK 15 mg tablet + Paclitaxel 10mg, 30mg capsules
Sponsors
Hanmi Pharmaceutical Company Limited
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patients must histologically or cytologically be diagnosed to have an advanced solid cancer. (phaseI) 2. Advanced/metastatic/recurred gastric cancer(PhaseII) 3. ECOG performance status ≤ 2 4. Patients have proper bone marrow, kidney, liver function and patients do not have remarkable dysfunction of heart and lung: WBC≥4000/mm3; Platelet ≥100,000/mm3; Hemoglobin≥9.0g/dL; ANC≥ 1,500 /mm3; Creatinine ≤ 1.5mg/dL; AST/ALT/ALP ≤ 3 X the upper limit of normal; Total bilirubin ≤2.0mg/dL \*AST/ALT/ALP ≤ 3 X the upper limit of normal but \<5 if liver or bone metastasis is present
Exclusion criteria
1. Patients with blood tumor (ex, leukemia), uncontrolled infectious disease, neurologic disorders, metastasis to CNS or ileus (patients requiring non-oral administration of anti-biotics to treat active bacterial infection are nor eligible, but patients can participate in the trial after complete eradication or control of the infection) 2. Patients who have received bone marrow transplant or are to receive bone marrow transplant. 3. Patients who had the medical history of atrial or ventricular arrhythmia or congestive heart failure or received medical treatment for myocardial infarction within 6 months.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Toxicity evaluation (safety evaluation) | DLT will be assessed on 28days of 1 cycle | Toxicity will be evaluated by medical history, vital signs, physical examination and laboratory tests performed during the screening period (D-28 to D0) and treatment period based on NCI-CTCAE (version 3.0). |
| Overall response rate(ORR) evaluation | Response will be evaluated every Cycle 2(8weeks) | It is measured up to confirmation of tumor response(CR, PR) Tumor response will be evaluated by RECIST v1.0. |
Countries
South Korea
Contacts
Primary ContactKyung-Mi Park, Ph.D
Outcome results
None listed