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A Study of Oraxol® in Gastric Cancer Patients

Primary Purpose

Advanced Metastatic Gastric Cancer, Recurrent Gastric Cancer

Status
Unknown status
Phase
Phase 1
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Paclitaxel
Sponsored by
Hanmi Pharmaceutical Company Limited
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Advanced Metastatic Gastric Cancer focused on measuring Oraxol®, oral paclitaxel, paclitaxel, HM30181A, MTD, DLT, RD

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • National Cancer CenterRecruiting
  • Seoul National University HospitalRecruiting

Outcomes

Primary Outcome Measures

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).
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.

Secondary Outcome Measures

Full Information

First Posted
December 5, 2011
Last Updated
December 11, 2011
Sponsor
Hanmi Pharmaceutical Company Limited
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1. Study Identification

Unique Protocol Identification Number
NCT01491217
Brief Title
A Study of Oraxol® in Gastric Cancer Patients
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 Type
Interventional

2. Study Status

Record Verification Date
December 2011
Overall Recruitment Status
Unknown status
Study Start Date
May 2009 (undefined)
Primary Completion Date
March 2012 (Anticipated)
Study Completion Date
December 2012 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hanmi Pharmaceutical Company Limited

4. Oversight

Data Monitoring Committee
No

5. 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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced Metastatic Gastric Cancer, Recurrent Gastric Cancer
Keywords
Oraxol®, oral paclitaxel, paclitaxel, HM30181A, MTD, DLT, RD

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
53 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Paclitaxel
Intervention Description
HM30181AK 15 mg tablet + Paclitaxel 10mg, 30mg capsules
Primary Outcome Measure Information:
Title
Toxicity evaluation (safety evaluation)
Description
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).
Time Frame
DLT will be assessed on 28days of 1 cycle
Title
Overall response rate(ORR) evaluation
Description
It is measured up to confirmation of tumor response(CR, PR) Tumor response will be evaluated by RECIST v1.0.
Time Frame
Response will be evaluated every Cycle 2(8weeks)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kyung-Mi Park, Ph.D
Email
kmpark@hanmi.co.kr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yung-Jue Bang, MD. Ph.D
Organizational Affiliation
Seoul National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Cancer Center
City
Goyang
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sook Ryun Park, M.D, Ph.D
Facility Name
Seoul National University Hospital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yung-Jue Bang, M.D, Ph.D

12. IPD Sharing Statement

Citations:
PubMed Identifier
26112004
Citation
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.
Results Reference
derived

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A Study of Oraxol® in Gastric Cancer Patients

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