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Completed

NCT Number: NCT00882973

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

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.

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Key information

Conditions

Pancreatic Cancer Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Neoplasms Neoplasms by Site Pancreatic Diseases Pancreatic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Genexol-PM

Drug

Cremophor EL-free polymeric micelle of paclitaxel

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Samyang Biopharmaceuticals Corporation

Industry

Registry information

Important dates

Study start
2008
Primary completion
2009
Study completion
2010
First posted
Apr 17, 2009
Registry last updated
May 5, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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