A Study of Oraxol® in Gastric Cancer Patients

Hanmi Pharmaceutical

Status and phase: Unknown; Phase 2; Phase 1

Conditions: Recurrent Gastric Cancer; Advanced Metastatic Gastric Cancer

Treatments: Drug: Paclitaxel

Study type: Interventional

Funder types: Industry

Identifiers

NCT01491217

HM-OXL-201

Details and patient eligibility

About

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.

Full 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).

Enrollment: 53 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)