A Study of Oraxol® in Gastric Cancer Patients

Recurrent Gastric Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Unknown status

Administrative data

• NCT number: NCT01491217
• Other study ID #: HM-OXL-201
• Status: Unknown status
• Phase: Phase 1/Phase 2
• First received: December 5, 2011
• Last updated: December 11, 2011
• Start date: May 2009
• Est. completion date: December 2012

Study information

• Verified date: December 2011
• Source: Hanmi Pharmaceutical Company Limited
• Contact: Kyung-Mi Park, Ph.D
• Email: kmpark[@]hanmi.co.kr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Unknown status
• Enrollment: 53
• Est. completion date: December 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Advanced Metastatic Gastric Cancer
• Recurrent Gastric Cancer
• Stomach Neoplasms

Intervention

Drug:
• Paclitaxel
HM30181AK 15 mg tablet + Paclitaxel 10mg, 30mg capsules

Locations

Country	Name	City	State
Korea, Republic of	National Cancer Center	Goyang
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Hanmi Pharmaceutical Company Limited

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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)