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
May 2, 2017 updated by: Samyang Biopharmaceuticals Corporation
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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
18
Phase
- Phase 1
Participation Criteria
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.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NON_RANDOMIZED
- Interventional Model: PARALLEL
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: Cohort 1
Genexol-PM 220 mg/m2 + Gemcitabine 1,250 mg/m2
|
Cremophor EL-free polymeric micelle of paclitaxel
|
|
EXPERIMENTAL: Cohort 2
Genexol-PM 260 mg/m2 + Gemcitabine 1,250 mg/m2
|
Cremophor EL-free polymeric micelle of paclitaxel
|
|
EXPERIMENTAL: Cohort 3
Genexol-PM 300 mg/m2 + Gemcitabine 1,250 mg/m2
|
Cremophor EL-free polymeric micelle of paclitaxel
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
The maximum tolerated dose (MTD) of the combination therapy with Genexol-PM and gemcitabine
Time Frame: 1 year
|
1 year
|
|
The recommended phase II dose of the combination therapy with Genexol-PM and gemcitabine
Time Frame: 1 year
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Progression free survival
Time Frame: 1 year
|
1 year
|
|
Time to tumor progression
Time Frame: 1 year
|
1 year
|
|
Objective response rate (complete response (CR) + partial response (PR))
Time Frame: 1 year
|
1 year
|
|
Safety profiles
Time Frame: 1 year
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
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 Major Dates
Study Start (ACTUAL)
September 1, 2008
Primary Completion (ACTUAL)
August 1, 2009
Study Completion (ACTUAL)
November 1, 2010
Study Registration Dates
First Submitted
April 16, 2009
First Submitted That Met QC Criteria
April 16, 2009
First Posted (ESTIMATE)
April 17, 2009
Study Record Updates
Last Update Posted (ACTUAL)
May 5, 2017
Last Update Submitted That Met QC Criteria
May 2, 2017
Last Verified
May 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- GPMPC202
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.