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Trial to Determine the Maximum Tolerated Dose of Genexol-PM Plus Gemcitabine and Evaluate Efficacy and Safety of Genexol-PM Regimens in Subjects With Advanced Pancreatic Cancer

Primary Purpose

Pancreatic Cancer

Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Genexol-PM
Sponsored by
Samyang Biopharmaceuticals Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pancreatic Cancer

Eligibility Criteria

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

Inclusion Criteria:

  1. Subjects who aged 18 years or older
  2. Subjects whose written informed consent was obtained complying with the local regulatory requirements prior to their participation in the trial
  3. Subjects who have histologically or cytologically confirmed unresectable or metastatic epithelial cancer of the exocrine pancreas. High-quality contrast-enhanced CT scanning is required to evaluate resectability. Measurable disease is not required.

  4. Subjects with no other malignancy diagnosed within past five years except for:

    • Cured non-melanoma skin cancer
    • Cured cervical intraepithelial neoplasia (CIN)
    • Cured In-situ cervical cancer (CIS)
  5. Subjects who are ECOG performance status of ≤ 1

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    Experimental

    Arm Label

    Cohort 1

    Cohort 2

    Cohort 3

    Arm Description

    Genexol-PM 220 mg/m2 + Gemcitabine 1,250 mg/m2

    Genexol-PM 260 mg/m2 + Gemcitabine 1,250 mg/m2

    Genexol-PM 300 mg/m2 + Gemcitabine 1,250 mg/m2

    Outcomes

    Primary Outcome Measures

    The maximum tolerated dose (MTD) of the combination therapy with Genexol-PM and gemcitabine
    The recommended phase II dose of the combination therapy with Genexol-PM and gemcitabine

    Secondary Outcome Measures

    Objective response rate (complete response (CR) + partial response (PR))
    Time to tumor progression
    Progression free survival
    Safety profiles

    Full Information

    First Posted
    April 16, 2009
    Last Updated
    May 2, 2017
    Sponsor
    Samyang Biopharmaceuticals Corporation
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00882973
    Brief Title
    Trial to Determine the Maximum Tolerated Dose of Genexol-PM Plus Gemcitabine and Evaluate Efficacy and Safety of Genexol-PM Regimens in Subjects With Advanced Pancreatic Cancer
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    September 2008 (Actual)
    Primary Completion Date
    August 2009 (Actual)
    Study Completion Date
    November 2010 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Samyang Biopharmaceuticals Corporation

    4. Oversight

    5. Study Description

    Brief Summary
    This is a phase I/II trial to determine the maximum tolerated dose and recommended phase II dose of the combination therapy with Genexol-PM and gemcitabine (hereafter Genexol-PM plus gemcitabine) and to evaluate the efficacy and safety of Genexol-PM regimens (monotherapy and combination with gemcitabine) and gemcitabine monotherapy in subjects with locally advanced or metastatic pancreatic cancer.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Pancreatic Cancer

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1
    Interventional Study Model
    Parallel Assignment
    Allocation
    Non-Randomized
    Enrollment
    18 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Cohort 1
    Arm Type
    Experimental
    Arm Description
    Genexol-PM 220 mg/m2 + Gemcitabine 1,250 mg/m2
    Arm Title
    Cohort 2
    Arm Type
    Experimental
    Arm Description
    Genexol-PM 260 mg/m2 + Gemcitabine 1,250 mg/m2
    Arm Title
    Cohort 3
    Arm Type
    Experimental
    Arm Description
    Genexol-PM 300 mg/m2 + Gemcitabine 1,250 mg/m2
    Intervention Type
    Drug
    Intervention Name(s)
    Genexol-PM
    Intervention Description
    Cremophor EL-free polymeric micelle of paclitaxel
    Primary Outcome Measure Information:
    Title
    The maximum tolerated dose (MTD) of the combination therapy with Genexol-PM and gemcitabine
    Time Frame
    1 year
    Title
    The recommended phase II dose of the combination therapy with Genexol-PM and gemcitabine
    Time Frame
    1 year
    Secondary Outcome Measure Information:
    Title
    Objective response rate (complete response (CR) + partial response (PR))
    Time Frame
    1 year
    Title
    Time to tumor progression
    Time Frame
    1 year
    Title
    Progression free survival
    Time Frame
    1 year
    Title
    Safety profiles
    Time Frame
    1 year

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Subjects who aged 18 years or older Subjects whose written informed consent was obtained complying with the local regulatory requirements prior to their participation in the trial Subjects who have histologically or cytologically confirmed unresectable or metastatic epithelial cancer of the exocrine pancreas. High-quality contrast-enhanced CT scanning is required to evaluate resectability. Measurable disease is not required. Subjects with no other malignancy diagnosed within past five years except for: Cured non-melanoma skin cancer Cured cervical intraepithelial neoplasia (CIN) Cured In-situ cervical cancer (CIS) Subjects who are ECOG performance status of ≤ 1

    12. IPD Sharing Statement

    Learn more about this trial

    Trial to Determine the Maximum Tolerated Dose of Genexol-PM Plus Gemcitabine and Evaluate Efficacy and Safety of Genexol-PM Regimens in Subjects With Advanced Pancreatic Cancer

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