---
title: Clinical Trial Evaluating Low Dose G-FLIP Plus Mitomycin C for Stage IV Pancreatic Cancer
nct_id: NCT06233877
overall_status: NOT_YET_RECRUITING
phase: PHASE2
sponsor: Hirschfeld Oncology
study_type: INTERVENTIONAL
primary_condition: Pancreatic Cancer
countries: United States
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT06233877.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT06233877"
ct_last_update_post_date: 2024-02-28
last_seen_at: "2026-05-12T07:14:16.385Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Clinical Trial Evaluating Low Dose G-FLIP Plus Mitomycin C for Stage IV Pancreatic Cancer

**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

**NCT ID:** [NCT06233877](https://clinicaltrials.gov/study/NCT06233877)

## Key Facts

- **Status:** NOT_YET_RECRUITING
- **Phase:** PHASE2
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 60
- **Lead Sponsor:** Hirschfeld Oncology
- **Conditions:** Pancreatic Cancer
- **Start Date:** 2024-03-15
- **Completion Date:** 2028-01-31
- **CT.gov Last Update:** 2024-02-28

## 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.

## Detailed 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.

## Eligibility

- **Minimum age:** 18 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
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
```

## Arms

- **G-GLIP plus Mitomycin C** (EXPERIMENTAL) — G-FLIP: Gemcitabine, Fluorouracil, Leucovorin, Irinotecan, and Oxaliplatin every 2 weeks plus Mitomycin C every 4 weeks

## Interventions

- **G-GLIP plus Mitomycin C** (DRUG) — G-FLIP: Gemcitabine, Fluorouracil, Leucovorin, Irinotecan, and Oxaliplatin plus Mitomycin C

## Primary Outcomes

- **Overall Survival** _(time frame: Baseline, 3 months, 6 months, 1 year, and then annually up to 5 years.)_ — This measure assesses the duration of time from the start of the study until death from any cause.
- **Response Rate** _(time frame: Baseline, 3 months, 6 months, 1 year, and then annually up to 5 years.)_ — 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."

## Locations (1)

- Hirscheld Oncology, Brooklyn, New York, United States

## Recent Field Changes (last 30 days)

- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.hirscheld oncology|brooklyn|new york|united states` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT06233877.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT06233877*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*