A Study of Oraxol® in Gastric Cancer Patients

Study Overview
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Brief Summary
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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
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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).

Official Title
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A Phase I-II Clinical Trial to Determine Recommended Dose and to Assess the Efficacy, Safety and Pharmacokinetic Profile of Oral Paclitaxel(Oraxol®) in Patients With Advanced/Metastatic or Recurrent Gastric Cancer

Conditions
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Advanced Metastatic Gastric Cancer, Recurrent Gastric Cancer

Intervention / Treatment
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* Drug: Paclitaxel


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients must histologically or cytologically be diagnosed to have an advanced solid cancer. (phaseI) Advanced/metastatic/recurred gastric cancer(PhaseII) ECOG performance status ≤ 2 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: 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) Patients who have received bone marrow transplant or are to receive bone marrow transplant. 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.

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Paclitaxel|HM30181AK 15 mg tablet + Paclitaxel 10mg, 30mg capsules|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Toxicity evaluation (safety evaluation) | 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). | DLT will be assessed on 28days of 1 cycle | 
| Overall response rate(ORR) evaluation | It is measured up to confirmation of tumor response(CR, PR) Tumor response will be evaluated by RECIST v1.0. | Response will be evaluated every Cycle 2(8weeks) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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oral paclitaxel, Oraxol®, paclitaxel, HM30181A, MTD, DLT, RD