A Study of Oraxol® in Gastric Cancer Patients

Phase 1

• Conditions: Advanced Metastatic Gastric Cancer; Recurrent Gastric Cancer

• Registration Number: NCT01491217
• Lead Sponsor: Hanmi Pharmaceutical Company Limited

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).

Study Timeline

• Study Start: 2009-05
• Status Verified: 2011-12
• Study First Submitted: 2011-12-05
• Study First Submitted QC: 2011-12-11
• Last Update Submitted: 2011-12-11
• Study First Posted: 2011-12-13
• Last Update Posted: 2011-12-13
• Primary Completion: 2012-03
• Study Completion: 2012-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 53

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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.
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).

Trial Locations

Locations (2)

National Cancer Center; 🇰🇷 Goyang, Korea, Republic of

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of