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Trial Title:
A Study of Oraxol® in Gastric Cancer Patients
NCT ID:
NCT01491217
Condition:
Advanced Metastatic Gastric Cancer
Recurrent Gastric Cancer
Conditions: Official terms:
Stomach Neoplasms
Paclitaxel
Conditions: Keywords:
Oraxol®
oral paclitaxel
paclitaxel
HM30181A
MTD
DLT
RD
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Unknown status
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Paclitaxel
Description:
HM30181AK 15 mg tablet + Paclitaxel 10mg, 30mg capsules
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).
Criteria for eligibility:
Criteria:
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.
Gender:
All
Minimum age:
19 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
National Cancer Center
Address:
City:
Goyang
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Last name:
Sook Ryun Park, M.D, Ph.D
Facility:
Name:
Seoul National University Hospital
Address:
City:
Seoul
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Last name:
Yung-Jue Bang, M.D, Ph.D
Start date:
May 2009
Completion date:
December 2012
Lead sponsor:
Agency:
Hanmi Pharmaceutical Company Limited
Agency class:
Industry
Source:
Hanmi Pharmaceutical Company Limited
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT01491217
