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A Study of Oraxol® in Gastric Cancer Patients

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ClinicalTrials.gov Identifier: NCT01491217
Recruitment Status : Unknown
Verified December 2011 by Hanmi Pharmaceutical Company Limited.
Recruitment status was:  Recruiting
First Posted : December 13, 2011
Last Update Posted : December 13, 2011
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Advanced Metastatic Gastric Cancer Recurrent Gastric Cancer Drug: Paclitaxel Phase 1 Phase 2

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 Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 53 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : May 2009
Estimated Primary Completion Date : March 2012
Estimated Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stomach Cancer
Drug Information available for: Paclitaxel
U.S. FDA Resources

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :
  1. Toxicity evaluation (safety evaluation) [ Time Frame: 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).

  2. Overall response rate(ORR) evaluation [ Time Frame: 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.



Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01491217


Contacts
Contact: Kyung-Mi Park, Ph.D kmpark@hanmi.co.kr

Locations
Korea, Republic of
National Cancer Center Recruiting
Goyang, Korea, Republic of
Contact: Sook Ryun Park, M.D, Ph.D         
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of
Contact: Yung-Jue Bang, M.D, Ph.D         
Sponsors and Collaborators
Hanmi Pharmaceutical Company Limited
Investigators
Principal Investigator: Yung-Jue Bang, MD. Ph.D Seoul National University Hospital
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Hanmi Pharmaceutical Company Limited
ClinicalTrials.gov Identifier: NCT01491217     History of Changes
Other Study ID Numbers: HM-OXL-201
First Posted: December 13, 2011    Key Record Dates
Last Update Posted: December 13, 2011
Last Verified: December 2011

Keywords provided by Hanmi Pharmaceutical Company Limited:
Oraxol®
oral paclitaxel
paclitaxel
HM30181A
MTD
DLT
RD

Additional relevant MeSH terms:
Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Paclitaxel
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action