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
Information provided by:
Samyang Biopharmaceuticals Corporation
First received: April 16, 2009
Last updated: NA
Last verified: April 2009
History: No changes posted
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.
Drug: Genexol-PM and gemcitabine
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
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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
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No publications provided
History of Changes
|Other Study ID Numbers:
|Study First Received:
||April 16, 2009
||April 16, 2009
||Russia: Ethics Committee
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on May 04, 2015
Digestive System Diseases
Digestive System Neoplasms
Endocrine Gland Neoplasms
Endocrine System Diseases
Neoplasms by Site
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs