A Study of Oraxol® in Gastric Cancer Patients
The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2011 by Hanmi Pharmaceutical Company Limited.
Recruitment status was Recruiting
Information provided by (Responsible Party):
Hanmi Pharmaceutical Company Limited
First received: December 5, 2011
Last updated: December 11, 2011
Last verified: December 2011
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.
Advanced Metastatic Gastric Cancer
Recurrent Gastric Cancer
||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||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
Primary Outcome Measures:
- Toxicity evaluation (safety evaluation) [ Time Frame: DLT will be assessed on 28days of 1 cycle ] [ Designated as safety issue: Yes ]
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).
- Overall response rate(ORR) evaluation [ Time Frame: Response will be evaluated every Cycle 2(8weeks) ] [ Designated as safety issue: No ]
It is measured up to confirmation of tumor response(CR, PR)
Tumor response will be evaluated by RECIST v1.0.
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||March 2012 (Final data collection date for primary outcome measure)
HM30181AK 15 mg tablet + Paclitaxel 10mg, 30mg capsules
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).
|Ages Eligible for Study:
||19 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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
- 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.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01491217
|National Cancer Center
|Goyang, Korea, Republic of |
|Contact: Sook Ryun Park, M.D, Ph.D |
|Seoul National University Hospital
|Seoul, Korea, Republic of |
|Contact: Yung-Jue Bang, M.D, Ph.D |
Hanmi Pharmaceutical Company Limited
||Yung-Jue Bang, MD. Ph.D
||Seoul National University Hospital
No publications provided
||Hanmi Pharmaceutical Company Limited
History of Changes
|Other Study ID Numbers:
|Study First Received:
||December 5, 2011
||December 11, 2011
||Korea: Food and Drug Administration
Keywords provided by Hanmi Pharmaceutical Company Limited:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on October 20, 2014
Digestive System Diseases
Digestive System Neoplasms
Neoplasms by Site
Antineoplastic Agents, Phytogenic
Molecular Mechanisms of Pharmacological Action