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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2009 by Samyang Biopharmaceuticals Corporation.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Samyang Biopharmaceuticals Corporation
ClinicalTrials.gov Identifier:
NCT00882973
First received: April 16, 2009
Last updated: NA
Last verified: April 2009
History: No changes posted
  Purpose

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 Intervention Phase
Pancreatic Cancer
Drug: Genexol-PM and gemcitabine
Phase 1
Phase 2

Study Type: Interventional

Resource links provided by NLM:


Further study details as provided by Samyang Biopharmaceuticals Corporation:

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00882973     History of Changes
Other Study ID Numbers: GPMPC202
Study First Received: April 16, 2009
Last Updated: April 16, 2009
Health Authority: Russia: Ethics Committee

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
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Radiation-Sensitizing Agents

ClinicalTrials.gov processed this record on August 21, 2014