A Study of Oraxol® in Gastric Cancer Patients

December 11, 2011 updated by: Hanmi Pharmaceutical Company Limited

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Drug: Paclitaxel

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 Type

Interventional

Enrollment (Anticipated)

Phase

Phase 2
Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Korea, Republic of
- - Goyang, Korea, Republic of
    - Recruiting
    - National Cancer Center
    - Contact:
      
      Sook Ryun Park, M.D, Ph.D
  - Seoul, Korea, Republic of
    - Recruiting
    - Seoul National University Hospital
    - Contact:
      
      Yung-Jue Bang, M.D, Ph.D

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: N/A
Interventional Model: Single Group Assignment
Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	DLT will be assessed on 28days of 1 cycle
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.	Response will be evaluated every Cycle 2(8weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hanmi Pharmaceutical Company Limited

Investigators

Principal Investigator: Yung-Jue Bang, MD. Ph.D, Seoul National University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Lee KW, Lee KH, Zang DY, Park YI, Shin DB, Kim JW, Im SA, Koh SA, Yu KS, Cho JY, Jung JA, Bang YJ. Phase I/II Study of Weekly Oraxol for the Second-Line Treatment of Patients With Metastatic or Recurrent Gastric Cancer. Oncologist. 2015 Aug;20(8):896-7. doi: 10.1634/theoncologist.2015-0202. Epub 2015 Jun 25.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2009

Primary Completion (Anticipated)

March 1, 2012

Study Completion (Anticipated)

December 1, 2012

Study Registration Dates

First Submitted

December 5, 2011

First Submitted That Met QC Criteria

December 11, 2011

First Posted (Estimate)

December 13, 2011

Study Record Updates

Last Update Posted (Estimate)