Clinical Trial Evaluating Low Dose G-FLIP Plus Mitomycin C for Stage IV Pancreatic Cancer

Pancreatic Cancer Clinical Trial

— GFLIPM  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06233877
• Other study ID #: G-FLIP-M Pancreatic
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: March 15, 2024
• Est. completion date: January 31, 2028

Study information

• Verified date: February 2024
• Source: Hirschfeld Oncology
• Contact: Azriel Hirschfeld, MD
• Phone: 7187324050
• Email: ah[@]honcology.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Objective: Evaluate the safety, tolerability, and efficacy of G-FLIP combined with Mitomycin C for advanced pancreatic cancer.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: January 31, 2028
• Est. primary completion date: January 31, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• • Known brain metastases.

• Significant cardiovascular or other uncontrolled diseases.

• Pregnant or breastfeeding women

Related Conditions & MeSH terms

• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

Drug:
• G-GLIP plus Mitomycin C
G-FLIP: Gemcitabine, Fluorouracil, Leucovorin, Irinotecan, and Oxaliplatin plus Mitomycin C

Locations

Country	Name	City	State
United States	Hirscheld Oncology	Brooklyn	New York

Sponsors (1)

Lead Sponsor	Collaborator
Hirschfeld Oncology

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.