Glufosfamide Versus 5-FU in Second Line Metastatic Pancreatic Cancer
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT01954992 |
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Recruitment Status :
Recruiting
First Posted : October 7, 2013
Last Update Posted : May 10, 2021
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Sponsor:
Eleison Pharmaceuticals LLC.
Information provided by (Responsible Party):
Eleison Pharmaceuticals LLC.
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Brief 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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Metastatic Pancreatic Adenocarcinoma | Drug: Glufosfamide Drug: Fluorouracil | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 480 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | 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 |
| Study Start Date : | April 2014 |
| Estimated Primary Completion Date : | December 2022 |
| Estimated Study Completion Date : | March 2023 |
Resource links provided by the National Library of Medicine
Drug Information available for:
Fluorouracil
| Arm | Intervention/treatment |
|---|---|
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Experimental: glufosfamide
Glufosfamide: 4500 mg/m2 IV over 6 hours on Day 1 of each 21-day cycle
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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. |
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Active Comparator: 5-FU
Fluorouracil (5-FU): 600 mg/m2 IV over 30 minutes on Day 1 of each week
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Drug: Fluorouracil
Fluorouracil (5-FU): 600 mg/m2 IV over 30 minutes on Day 1 of each week
Other Name: 5-FU |
Primary Outcome Measures :
- Overall Survival [ Time Frame: Approximately 3-6 months ]Time from Randomization to death from any cause
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- At least 18 years of age
- Pancreatic adenocarcinoma proven either by histology (surgical biopsy) or cytology (CT- or endoscopic-guided)
- Metastatic pancreatic cancer
- Disease progression during or after treatment with gemcitabine (alone or in combination with other agents; at regular, not radiosensitizing, doses)
- Measurable or nonmeasurable disease by RECIST criteria (at least one target or nontarget lesion)
- Recovered from reversible toxicities of prior therapy
- ECOG performance status 0-1
- 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
- Ability to understand the purposes and risks of the study and has signed a written informed consent form approved by the investigator's IRB/Ethics Committee
Exclusion Criteria:
- More than one prior systemic therapy regimen for metastatic pancreatic cancer (radiosensitizing doses of 5-FU or gemcitabine at the time of initial radiotherapy do not count as a prior systemic therapy regimen)
- Hormonal therapy, radiation therapy, biologic therapy, chemotherapy or other systemic antitumor therapy for pancreatic cancer within 14 days prior to Cycle 1 Day 1
- Insulin-dependent diabetes mellitus (patients with type 2 diabetes controlled with oral glucose lowering agents and the occasional use of insulin are permitted in the study)
- Symptomatic brain metastases (baseline CT scan is not required in asymptomatic patients)
- Active clinically significant infection requiring antibiotics
- Known HIV positive or active hepatitis B or C
- Recent (one year) history or symptoms of cardiovascular disease (NYHA Class 2, 3, or 4), particularly coronary artery disease, arrhythmias or conduction defects with risk of cardiovascular instability, uncontrolled hypertension, clinically significant pericardial effusion, or congestive heart failure
- No other active malignancies (other than treated non-melanoma skin cancer or treated in situ cancer) within the past year
- Major surgery within 3 weeks of the start of study treatment, without complete recovery
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Clinically significant abnormalities in laboratory test results (including complete blood count, chemistry panel including electrolytes, and urinalysis)
- Hemoglobin <9 g/dL (may receive transfusion or erythropoietin to maintain)
- ANC <1500/μL
- Platelet count <100,000/μL
- Total bilirubin > 1.5×ULN
- AST/ALT > 2.5-fold above ULN (>5-fold above ULN if liver metastases)
- Phosphorus < LLN
- Potassium < LLN
- Serum creatinine > 2 mg/dL
- Creatinine clearance < 60 mL/min (calculated by Cockcroft-Gault formula)
- Females who are pregnant or breast-feeding
- Participation in an investigational drug or device study within 14 days of the first day of dosing on this study
- Concomitant disease or condition that could interfere with the conduct of the study, or that would, in the opinion of the investigator, pose an unacceptable risk to the patient in this study
- Any medical history, concurrent disease or concomitant medication which could reasonably predispose the patient to renal insufficiency while on study treatment
- Contraindication or unwillingness to undergo multiple CT scans
- Unwillingness or inability to comply with the study protocol for any other reason
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01954992
Contacts
| Contact: Edwin Thomas | 215 554 3530 | clinical@eleison-pharma.com |
Locations
Show 22 study locations
Sponsors and Collaborators
Eleison Pharmaceuticals LLC.
Investigators
| Study Director: | Edwin Thomas | Eleison Pharmaceuticals |
| Responsible Party: | Eleison Pharmaceuticals LLC. |
| ClinicalTrials.gov Identifier: | NCT01954992 |
| Other Study ID Numbers: |
EP-GF-301 |
| First Posted: | October 7, 2013 Key Record Dates |
| Last Update Posted: | May 10, 2021 |
| Last Verified: | May 2021 |
Keywords provided by Eleison Pharmaceuticals LLC.:
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glufosfamide 5-FU metastatic pancreatic adenocarcinoma |
Additional relevant MeSH terms:
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Adenocarcinoma Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Fluorouracil Antimetabolites |
Molecular Mechanisms of Pharmacological Action Antimetabolites, Antineoplastic Antineoplastic Agents Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs |