Text Size

A Study of Oraxol® in Gastric Cancer Patients

This study is currently recruiting participants.
Verified December 2011 by Hanmi Pharmaceutical Company Limited
Sponsor:
Information provided by (Responsible Party):
Hanmi Pharmaceutical Company Limited
ClinicalTrials.gov Identifier:
NCT01491217
First received: December 5, 2011
Last updated: December 11, 2011
Last verified: December 2011
History of Changes
  Purpose

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 Intervention Phase
Advanced Metastatic Gastric Cancer
Recurrent Gastric Cancer
 Drug: Paclitaxel
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

Drug Information available for: Paclitaxel
U.S. FDA Resources

Further study details as provided by Hanmi Pharmaceutical Company Limited:

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: 53
Study Start Date: May 2009
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Paclitaxel
    HM30181AK 15 mg tablet + Paclitaxel 10mg, 30mg capsules
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).

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Hanmi Pharmaceutical Company Limited
ClinicalTrials.gov Identifier: NCT01491217     History of Changes
Other Study ID Numbers: HM-OXL-201
Study First Received: December 5, 2011
Last Updated: December 11, 2011
Health Authority: Korea: Food and Drug Administration

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
 Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 21, 2013