Overview

This trial is active, not recruiting.

Condition pancreatic cancer
Treatment genexol-pm and gemcitabine
Phase phase 1/phase 2
Sponsor Samyang Biopharmaceuticals Corporation
Trial identifier NCT00882973, GPMPC202

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.

United States No locations recruiting
Other Countries No locations recruiting

Primary Outcomes

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

Secondary Outcomes

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

Eligibility Criteria

Male or female participants at least 18 years old.

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

Trial information was received from ClinicalTrials.gov and was last updated in April 2009.
Information provided to ClinicalTrials.gov by Samyang Biopharmaceuticals Corporation.