Clinical Trial Evaluating Low Dose G-FLIP Plus Mitomycin C for Stage IV Pancreatic Cancer
GFLIPM
An Open Label Phase 2 Trial to Evaluate the Safety, Tolerability, and Efficacy of Low Dose G-FLIP in Combination With Mitomycin C in Patients With Stage IV Pancreatic Cancer Who Have Failed First-Line Treatment
1 other identifier
interventional
60
1 country
1
Brief Summary
The study focuses on advanced metastatic pancreatic cancer, testing a combination of low-dose anti-cancer drugs (G-FLIP: Gemcitabine, Fluorouracil, Leucovorin, Irinotecan, and Oxaliplatin) with the addition of Mitomycin C. The aim is to find a safer and more effective therapy for this devastating disease.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2 pancreatic-cancer
Started Mar 2024
1 active site
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
First Submitted
Initial submission to the registry
January 10, 2024
CompletedFirst Posted
Study publicly available on registry
January 31, 2024
CompletedStudy Start
First participant enrolled
March 15, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 31, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 31, 2028
February 28, 2024
February 1, 2024
2.9 years
January 10, 2024
February 26, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Overall Survival
This measure assesses the duration of time from the start of the study until death from any cause.
Baseline, 3 months, 6 months, 1 year, and then annually up to 5 years.
Response Rate
This measure assesses the rate of disease progression or worsening, as determined by changes in tumor size and appearance on radiological scans. The evaluation is conducted using the Response Evaluation Criteria in Solid Tumors (RECIST) guidelines, which provide a standardized method for measuring tumor size and categorizing response to treatment."
Baseline, 3 months, 6 months, 1 year, and then annually up to 5 years.
Study Arms (1)
G-GLIP plus Mitomycin C
EXPERIMENTALG-FLIP: Gemcitabine, Fluorouracil, Leucovorin, Irinotecan, and Oxaliplatin every 2 weeks plus Mitomycin C every 4 weeks
Interventions
G-FLIP: Gemcitabine, Fluorouracil, Leucovorin, Irinotecan, and Oxaliplatin plus Mitomycin C
Eligibility Criteria
You may qualify if:
- Histologically confirmed metastatic (Stage IV) pancreatic adenocarcinoma.
- 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.
You may not qualify if:
- Known brain metastases.
- Significant cardiovascular or other uncontrolled diseases.
- Pregnant or breastfeeding women
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hirscheld Oncology
Brooklyn, New York, 11206, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 10, 2024
First Posted
January 31, 2024
Study Start
March 15, 2024
Primary Completion (Estimated)
January 31, 2027
Study Completion (Estimated)
January 31, 2028
Last Updated
February 28, 2024
Record last verified: 2024-02