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Anti-metabolites

Glufosfamide vs Fluorouracil for Pancreatic Cancer

Phase 3
Recruiting
Research Sponsored by Eleison Pharmaceuticals LLC.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
All women of childbearing potential and all men must agree to use effective means of contraception (surgical sterilization or the use of barrier contraception with either a condom or diaphragm in conjunction with spermicidal gel or an IUD) from entry into the study through 6 months after the last dose of chemotherapy
Pancreatic adenocarcinoma proven either by histology (surgical biopsy) or cytology (CT- or endoscopic-guided)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up approximately 3-6 months
Awards & highlights

Study Summary

This trial is testing whether a different chemotherapy drug may help people with pancreatic cancer who have already tried and failed one gemcitabine-based chemotherapy regimen.

Who is the study for?
This trial is for adults with metastatic pancreatic cancer who have not responded to gemcitabine-based treatment. They must be in good physical condition, able to consent, and agree to use contraception. Exclusions include symptomatic brain metastases, active infections or other cancers, recent major surgery without recovery, significant lab abnormalities, pregnancy or breastfeeding, insulin-dependent diabetes, and certain heart conditions.Check my eligibility
What is being tested?
The study compares the effectiveness of glufosfamide versus fluorouracil (5-FU) in improving survival for patients with advanced pancreatic cancer after first-line therapy failure. Participants will receive either glufosfamide or bolus 5-FU as a second-line treatment option.See study design
What are the potential side effects?
Potential side effects may include reactions at the infusion site, nausea and vomiting from chemotherapy drugs like fluorouracil (5-FU), low blood counts leading to increased infection risk or bleeding tendencies, liver enzyme alterations suggesting liver stress or damage.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I agree to use effective contraception during and for 6 months after the study.
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My pancreatic cancer was confirmed through a biopsy.
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I am 18 years old or older.
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I am fully active or can carry out light work.
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My cancer has spread from the pancreas to other parts of my body.
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My condition worsened despite treatment with gemcitabine.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~approximately 3-6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately 3-6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Overall Survival

Side effects data

From 2008 Phase 2 trial • 22 Patients • NCT00441467
50%
Nausea
50%
Vomiting
23%
Fatigue
23%
Renal failure
23%
Alopecia
18%
Neutropenia
18%
Anorexia
14%
Fatigue aggravated
14%
Anemia aggravated
14%
Insomnia
14%
Nausea aggravated
9%
Weakness
9%
Pain aggravated
9%
Shoulder pain
9%
Dehydration
9%
Anemia
9%
Thrombocytopenia
9%
Hypokalemia
9%
Hypophosphatemia
9%
Depression aggravated
9%
Dizziness
9%
Headache
9%
Cough
9%
Dyspnea
9%
Dyspnea exacerbated
9%
Sore throat
9%
Abdominal bloating
9%
Abdominal pain
9%
Constipation
9%
Constipation agravated
9%
Diarrhea
9%
Mucositis oral
9%
Back pain aggravated
9%
General body pain
5%
Intractable nausea and vomiting
5%
Sarcoma site hemorrhage
100%
80%
60%
40%
20%
0%
Study treatment Arm
Glufosfamide

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: glufosfamideExperimental Treatment1 Intervention
Glufosfamide: 4500 mg/m2 IV over 6 hours on Day 1 of each 21-day cycle
Group II: 5-FUActive Control1 Intervention
Fluorouracil (5-FU): 600 mg/m2 IV over 30 minutes on Day 1 of each week
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Glufosfamide
Not yet FDA approved

Find a Location

Who is running the clinical trial?

Eleison Pharmaceuticals LLC.Lead Sponsor
3 Previous Clinical Trials
67 Total Patients Enrolled
Edwin ThomasStudy DirectorEleison Pharmaceuticals

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are people with the required medical conditions still able to join this clinical trial?

"According to the information available on clinicaltrials.gov, this study is still looking for participants. This trial was first advertised on April 1st, 2014 and received its most recent update on May 6th, 2021."

Answered by AI

What medical conditions typically respond best to Glufosfamide treatment?

"Glufosfamide can be used to target actinic keratosis, superficial basal cell carcinoma, rectal carcinoma, and malignant neoplasm of colon."

Answered by AI

Is this clinical trial widely available in the United States?

"You may want to consider enrolling in this clinical trial as it is currently recruiting patients from 19 different sites, which are based in locations including Arlington, Riverside and Louisville. To reduce travel-related stress, try to select the location closest to you."

Answered by AI

Are there any life-threatening risks associated with Glufosfamide?

"There is both efficacy and safety data available from Phase 3 trials, so Glufosfamide was given a score of 3 for safety."

Answered by AI

Are there other published papers on Glufosfamide's efficacy?

"As of right now, there are a total of 331 trials for Glufosfamide that are still recruiting patients. 106 of these studies have reached Phase 3. Additionally, while several clinical trials for Glufosfamide are based in Woolloongabba, Queensland, there are actually 18810 locations running trials related to this medication."

Answered by AI

How many people are allowed to participate in this clinical trial at one time?

"That is correct. The clinical trial, which was initially posted on 4/1/2014 and updated on 5/6/2021, is recruiting 480 patients from 19 different locations."

Answered by AI

Who else is applying?

What state do they live in?
California
How old are they?
18 - 65
What site did they apply to?
Comprehensive Cancer Care Medical Group, Inc.
Hao Wei Zhang MD, Inc.
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria

Why did patients apply to this trial?

Want to try whatever is available to treat my cancer.
PatientReceived no prior treatments
Recent research and studies
clinicaltrials.govStudy
Glufosfamide Versus 5-FU in Second Line Metastatic Pancreatic Cancer
2014. "Glufosfamide Versus 5-FU in Second Line Metastatic Pancreatic Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01954992.
All > Adenocarcinoma > Paid Studies Delaware
~47 spots leftby Jun 2025
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