Clinical Trial Evaluating Low Dose G-FLIP Plus Mitomycin C for Stage IV Pancreatic Cancer
NCT ID: NCT06233877
Last Updated: 2024-02-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE2
60 participants
INTERVENTIONAL
2024-03-15
2028-01-31
Brief Summary
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Detailed Description
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Design: Open-label study with 60 evaluable subjects. Treatments: G-FLIP administered every 2 weeks, with Mitomycin administered every 4 weeks.
Efficacy Assessments: Based on response criteria (Complete Response, Partial Response, Stable Disease, Progressive Disease), Response Rate, Progression-Free-Survival, Overall Survival, and 12-Month Survival Rate.
Safety Assessments: Include physical exams, symptom evaluation, vital signs, ECOG performance status, clinical pathology, urinalysis, and Quality of Life assessments.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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G-GLIP plus Mitomycin C
G-FLIP: Gemcitabine, Fluorouracil, Leucovorin, Irinotecan, and Oxaliplatin every 2 weeks plus Mitomycin C every 4 weeks
G-GLIP plus Mitomycin C
G-FLIP: Gemcitabine, Fluorouracil, Leucovorin, Irinotecan, and Oxaliplatin plus Mitomycin C
Interventions
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G-GLIP plus Mitomycin C
G-FLIP: Gemcitabine, Fluorouracil, Leucovorin, Irinotecan, and Oxaliplatin plus Mitomycin C
Eligibility Criteria
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Inclusion Criteria
* Failed first-line chemotherapy.
* ECOG performance status of 0-2.
* Expected survival of more than 3 months.
* Adequate organ function as indicated by lab values.
* Age 18 or older.
* Signed informed consent.
Exclusion Criteria
* Significant cardiovascular or other uncontrolled diseases.
* Pregnant or breastfeeding women
18 Years
ALL
No
Sponsors
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Hirschfeld Oncology
OTHER_GOV
Responsible Party
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Locations
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Hirscheld Oncology
Brooklyn, New York, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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G-FLIP-M Pancreatic
Identifier Type: -
Identifier Source: org_study_id
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