NCT01491217

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
53

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started May 2009

Typical duration for phase_1

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2009

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

December 5, 2011

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 13, 2011

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2012

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

December 13, 2011

Status Verified

December 1, 2011

Enrollment Period

2.8 years

First QC Date

December 5, 2011

Last Update Submit

December 11, 2011

Conditions

Advanced Metastatic Gastric CancerRecurrent Gastric Cancer

Keywords

Oraxol®oral paclitaxelpaclitaxelHM30181AMTDDLTRD

Outcome Measures

Primary Outcomes (2)

  • 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).

    DLT will be assessed on 28days of 1 cycle

  • 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.

    Response will be evaluated every Cycle 2(8weeks)

Interventions

PaclitaxelDRUG

HM30181AK 15 mg tablet + Paclitaxel 10mg, 30mg capsules

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

National Cancer Center

Goyang, South Korea

RECRUITING

Seoul National University Hospital

Seoul, South Korea

RECRUITING

Related Publications (1)

  • 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.

    PMID: 26112004DERIVED

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

Paclitaxel

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Intervention Hierarchy (Ancestors)

TaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenes

Study Officials

  • Yung-Jue Bang, MD. Ph.D

    Seoul National University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Kyung-Mi Park, Ph.D

CONTACT

kmpark@hanmi.co.kr

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 5, 2011

First Posted

December 13, 2011

Study Start

May 1, 2009

Primary Completion

March 1, 2012

Study Completion

December 1, 2012

Last Updated

December 13, 2011

Record last verified: 2011-12

Locations

KR(2)