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Glufosfamide Versus 5-FU in Second Line Metastatic Pancreatic Cancer

Information source: Eleison Pharmaceuticals LLC.
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Metastatic Pancreatic Adenocarcinoma

Intervention: Glufosfamide (Drug); Fluorouracil (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Eleison Pharmaceuticals LLC.

Official(s) and/or principal investigator(s):
Forrest Anthony, MD, PhD, Study Director, Affiliation: Eleison Pharmaceuticals

Overall contact:
Forrest Anthony, MD, PhD, Phone: 215-554-3530, Email: forrest.anthony@eleison-pharma.com

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.

Clinical Details

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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Overall Survival

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

- 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

Locations and Contacts

Forrest Anthony, MD, PhD, Phone: 215-554-3530, Email: forrest.anthony@eleison-pharma.com

Comprehensive Cancer Care Medical Group, Inc., Corona, California 92879, United States; Recruiting
Elsa Honorio, Phone: 951-276-2760, Email: ehonorio@compcareresearch.com
Rehana Baqai, Principal Investigator

Compassionate Care Research Group, Inc., Fountain Valley, California 92708, United States; Recruiting
Catherine Etheredge, Phone: 714-698-0300, Ext: 206, Email: cetheredge@compcareresearch.com
Haresh S Jhangiani, Principal Investigator

Hao Wei Zhang MD, Inc., Los Angeles, California 90033, United States; Recruiting
Eryn Ferdman, Phone: 424-208-8866, Email: Eryn@TRMLLC.com
Hao Wei Zhang, MD, Principal Investigator

Compassionate Cancer Care Medical Group, Inc., Riverside, California 92501, United States; Recruiting
Corina King, Phone: 951-276-2760, Email: cking@compcareresearch.com
Brian Choi, Principal Investigator

Innovative Clinical Research Institute, Whittier, California 90603, United States; Recruiting
Kirsten Bettino, Phone: 562-652-6532, Email: kbettino@airesearch.us
Richy Agajanian, MD, Principal Investigator

Christina Care Health System, Newark, Delaware 19713, United States; Recruiting
Kathy Combs, Phone: 302-623-4638, Email: kcombs@christinacare.org
Michael Guarino, Principal Investigator

Lakeland Regional Cancer Center, Lakeland, Florida 33805, United States; Recruiting
Robin Stewart, Phone: 863-904-1877, Email: robin.stewart@lrmc.com
Madhavi Venigalla, MD, Principal Investigator

Moffitt Cancer Center, Tampa, Florida 33612, United States; Recruiting
Michael Rowland, Phone: 813-745-1157, Email: michael.rowland@moffitt.org
Richard Kim, MD, Principal Investigator

Simmons Cancer Institute, Springfield, Illinois 62702, United States; Recruiting
Kathy Robinson, Phone: 217-545-7969, Email: krobinson@siumed.edu
Meghna Desai, MD, Principal Investigator

Investigative Clinical Research of Indiana, LLC, Indianapolis, Indiana 46260, United States; Recruiting
Heather Rather, Phone: 317-297-2208, Email: admin@investigativeicr.com
Robert F Manges, Principal Investigator

RHHP/Hope Center, Terre Haute, Indiana 47802, United States; Recruiting
Jacquelyn Bradfield, Phone: 812-234-0098, Email: Jacquelyn.bradfield@hcahealthcare.com
Ashis K Chakrabarti, MD, Principal Investigator

McFarland Clinic Oncology, Ames, Iowa 50010, United States; Recruiting
Sheri Gatchel, Phone: 515-239-2684, Email: gatchel@MGMC.com
Debra Prow, Principal Investigator

CBC Group Consulting in Blood Disorders and Cancer, PSC, Louisville, Kentucky 40207, United States; Recruiting
Kelly O'neill Richey, Phone: 502-897-1166, Ext: 1420, Email: kelly.oneillrichey@bhsi.com
Wanjian Zhong, Principal Investigator

Crescent City Research Consortium, Marrero, Louisiana 70072, United States; Recruiting
MaryAnn Ostroske, Phone: 594-885-8220, Email: Maryann.ostroske@wjmc.org
Vijay Patel, MD, Principal Investigator

Center for Cancer and Blood Disorders, Bethesda, Maryland 20817, United States; Recruiting
Natalie Bongiorno, Phone: 301-571-2016, Email: NBongiorno@CCBDMD.com
Ralph Boccia, MD, Principal Investigator

Reliant Medical Group, Worcester, Massachusetts 01608, United States; Recruiting
Marcia Kirkpatrick, RN, BSN, Phone: 508-556-5429, Email: marcia.kirkpatrick@reliantmedicalgroup.org
Amr Hassan, MD, Principal Investigator

Saint Louis University Cancer Center, St. Louis, Missouri 63110, United States; Recruiting
Stephanie Kalbouneh, Phone: 314-577-8916, Email: kalbousl@slu.edu
Nishant Poddar, MD, Principal Investigator

Dartmouth-Hitchcock Norris Cotton Cancer Center, Lebanon, New Hampshire 03756, United States; Recruiting
Maureen Stannard, Phone: 603-650-9474, Email: Maureen.G.Stannard@hitchcock.org
Greggory Ripple, MD, Principal Investigator

Regional Cancer Care Associates, Cherry Hill, New Jersey 08003, United States; Recruiting
Diane German, RN, BSN, Phone: 856-424-7983, Ext: 1703, Email: dgerman@regionalcancercare.org
Richard Greenberg, MD, Principal Investigator

Regional Cancer Care Associates, Pompton Plains, New Jersey 07444, United States; Recruiting
Danielle Schillen, RN, BSN, Phone: 917-690-7108, Email: dschillen@regionalcancercare.org
Andrew Bernstein, DO, Principal Investigator

Regional Cancer Care Associates, Somerville, New Jersey 08876, United States; Recruiting
Danielle Schillen, RN, BSN, Phone: 917-690-7108, Email: dschillen@regionalcancercare.org
Steven Young, MD, Principal Investigator

Regional Cancer Care Associates, Sparta, New Jersey 07871, United States; Recruiting
Marie Felix, RN, Phone: 973-729-8801, Email: mfelix@regionalcancercare.org
Bohdan E Halibey, MD, Principal Investigator

University of Rochester, Rochester, New York 14642, United States; Recruiting
Laurie Koek, CRC, Phone: 585-276-4448, Email: laurie_koek@urmc.rochester.edu
Marcus Noel, MD, Principal Investigator

SUNY Upstate Medical University, Syracuse, New York 13210, United States; Recruiting
Diane Gould, CCRP, Phone: 315-464-8235, Email: gouldd@upstate.edu
Rahul Seth, DO, Principal Investigator

Gabrail Cancer Center Research, Canton,, Ohio 44718, United States; Recruiting
Carrie Smith, Phone: 330-417-8231, Email: csmith@gabrailcancercenter.com
Nashat Gabrail, MD, Principal Investigator

Allegheny Singer Research Institute- West Penn, PIttsburgh, Pennsylvania 15212, United States; Recruiting
Susan Hebda, Phone: 412-491-1384, Email: shebda@wpahs.org
Moses Raj, Principal Investigator

The Jones Clinic, Germantown, Tennessee 38138, United States; Recruiting
Lori J Lynch, Phone: 901-685-5969, Ext: 322, Email: llynch@jonescancerclinic.com
Clyde Michael Jones, Principal Investigator

Center for Biomedical Research, Knoxville, Tennessee 37909, United States; Recruiting
Susie Owenby, Phone: 865-934-2672, Email: sowenby@biomed-research.com
David R Schumaker, Principal Investigator

Texas Health Physicians Group, Arlington, Texas 76012, United States; Recruiting
Lisa Carson, Phone: 972-755-8076, Email: lisacarson@texashealth.org
Lee Knox, Phone: 214-570-2334, Email: leeknox@texashealth.org
Alfred DiStefano, Principal Investigator

Texas Tech University Health Sciences Center, El Paso, Texas 79905, United States; Recruiting
Jacqueline Marek-Gamez, Phone: 915-215-4810, Ext: 3, Email: jacqueline.marek@ttuhsc.edu
Corral Javier, MD, Principal Investigator

Westchase Clinical Associates/Westchase Oncology Center, Houston, Texas 77042, United States; Recruiting
Reza Amerinia, Phone: 713-781-6200, Ext: 3204
Tannaz Armaghany, Principal Investigator

Additional Information

Starting date: September 2013
Last updated: February 23, 2015

Page last updated: August 20, 2015

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