2008-09
2009-08
2010-11
18
NCT00882973
Samyang Biopharmaceuticals Corporation
Samyang Biopharmaceuticals Corporation
INTERVENTIONAL
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.
N/A
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2009-04-16 | N/A | 2017-05-02 |
2009-04-16 | N/A | 2017-05-05 |
2009-04-17 | N/A | 2017-05 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Treatment
Allocation:
Non Randomized
Interventional Model:
Parallel
Masking:
N/A
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| EXPERIMENTAL: Cohort 1 Genexol-PM 220 mg/m2 + Gemcitabine 1,250 mg/m2 | DRUG: Genexol-PM
|
| EXPERIMENTAL: Cohort 2 Genexol-PM 260 mg/m2 + Gemcitabine 1,250 mg/m2 | DRUG: Genexol-PM
|
| EXPERIMENTAL: Cohort 3 Genexol-PM 300 mg/m2 + Gemcitabine 1,250 mg/m2 | DRUG: Genexol-PM
|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| The maximum tolerated dose (MTD) of the combination therapy with Genexol-PM and gemcitabine | 1 year | |
| The recommended phase II dose of the combination therapy with Genexol-PM and gemcitabine | 1 year |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Objective response rate (complete response (CR) + partial response (PR)) | 1 year | |
| Time to tumor progression | 1 year | |
| Progression free survival | 1 year | |
| Safety profiles | 1 year |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
No publications available
NPCF was founded on May 29, 2009 and is a 501(c)(3) organization. All donations are tax deductible.
The information and services provided by the National Pancreatic Cancer Foundation are for informational purposes only. The information and services are not intended to be substitutes for professional medical advice, diagnosis or treatment. The National Pancreatic Cancer Foundation does not recommend nor endorse any specific physicians, products or treatments even though they may be mentioned on this site.
Copyright © 2024 – National Pancreatic Cancer Foundation | All Rights Reserved
