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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

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ClinicalTrials.gov Identifier: NCT00882973
Recruitment Status : Completed
First Posted : April 17, 2009
Last Update Posted : May 5, 2017
Sponsor:
Information provided by (Responsible Party):
Samyang Biopharmaceuticals Corporation

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.

Condition or disease Intervention/treatment Phase
Pancreatic Cancer Drug: Genexol-PM Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
Actual Study Start Date : September 2008
Primary Completion Date : August 2009
Study Completion Date : November 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Cohort 1
Genexol-PM 220 mg/m2 + Gemcitabine 1,250 mg/m2
Drug: Genexol-PM
Cremophor EL-free polymeric micelle of paclitaxel
Experimental: Cohort 2
Genexol-PM 260 mg/m2 + Gemcitabine 1,250 mg/m2
Drug: Genexol-PM
Cremophor EL-free polymeric micelle of paclitaxel
Experimental: Cohort 3
Genexol-PM 300 mg/m2 + Gemcitabine 1,250 mg/m2
Drug: Genexol-PM
Cremophor EL-free polymeric micelle of paclitaxel



Primary Outcome Measures :
  1. The maximum tolerated dose (MTD) of the combination therapy with Genexol-PM and gemcitabine [ Time Frame: 1 year ]
  2. The recommended phase II dose of the combination therapy with Genexol-PM and gemcitabine [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Objective response rate (complete response (CR) + partial response (PR)) [ Time Frame: 1 year ]
  2. Time to tumor progression [ Time Frame: 1 year ]
  3. Progression free survival [ Time Frame: 1 year ]
  4. Safety profiles [ Time Frame: 1 year ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Responsible Party: Samyang Biopharmaceuticals Corporation
ClinicalTrials.gov Identifier: NCT00882973     History of Changes
Other Study ID Numbers: GPMPC202
First Posted: April 17, 2009    Key Record Dates
Last Update Posted: May 5, 2017
Last Verified: May 2017

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Gemcitabine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs