Trials / Recruiting
RecruitingNCT01954992
Glufosfamide Versus 5-FU in Second Line Metastatic Pancreatic Cancer
A Randomized Phase 3 Study of the Efficacy and Safety of Glufosfamide Compared With Fluorouracil (5-FU) in Patients With Metastatic Pancreatic Adenocarcinoma Previously Treated With Gemcitabine
- Status
- Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 480 (estimated)
- Sponsor
- Eleison Pharmaceuticals LLC. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The study is designed to assess whether glufosfamide provides additional survival benefit as compared to bolus 5-FU in patients with metastatic pancreatic cancer who have already progressed or failed therapy on a gemcitabine based first line regimen.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Glufosfamide | Glufosfamide: 4500 mg/m2 IV over 6 hours (¼ dose over 30 minutes, ¾ dose over remaining 5.5 hours) on Day 1 of each 21-day cycle. |
| DRUG | Fluorouracil | Fluorouracil (5-FU): 600 mg/m2 IV over 30 minutes on Day 1 of each week |
Timeline
- Start date
- 2014-04-01
- Primary completion
- 2026-06-01
- Completion
- 2026-12-01
- First posted
- 2013-10-07
- Last updated
- 2024-12-31
Locations
3 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT01954992. Inclusion in this directory is not an endorsement.