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
1 other identifier
interventional
18
0 countries
N/A
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1 pancreatic-cancer
Started Sep 2008
Shorter than P25 for phase_1 pancreatic-cancer
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2008
CompletedFirst Submitted
Initial submission to the registry
April 16, 2009
CompletedFirst Posted
Study publicly available on registry
April 17, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2010
CompletedMay 5, 2017
May 1, 2017
11 months
April 16, 2009
May 2, 2017
Conditions
Outcome Measures
Primary Outcomes (2)
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 Outcomes (4)
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
Study Arms (3)
Cohort 1
EXPERIMENTALGenexol-PM 220 mg/m2 + Gemcitabine 1,250 mg/m2
Cohort 2
EXPERIMENTALGenexol-PM 260 mg/m2 + Gemcitabine 1,250 mg/m2
Cohort 3
EXPERIMENTALGenexol-PM 300 mg/m2 + Gemcitabine 1,250 mg/m2
Interventions
Eligibility Criteria
You may qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 16, 2009
First Posted
April 17, 2009
Study Start
September 1, 2008
Primary Completion
August 1, 2009
Study Completion
November 1, 2010
Last Updated
May 5, 2017
Record last verified: 2017-05