Study of the Efficacy and Safety of Glufosfamide Compared With Best Supportive Care in Metastatic Pancreatic Cancer
A Randomized Phase 3 Study of the Efficacy and Safety of Glufosfamide Compared With Best Supportive Care in Metastatic Pancreatic Adenocarcinoma Previously Treated With Gemcitabine
1 other identifier
interventional
300
11 countries
111
Brief Summary
The primary objectives of the study is to evaluate the effectiveness and safety of glufosfamide in subjects with pancreatic cancer who have been previously treated with gemcitabine as measured by overall survival compared with best supportive care.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3 pancreatic-cancer
Started Sep 2004
Shorter than P25 for phase_3 pancreatic-cancer
111 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2004
CompletedFirst Submitted
Initial submission to the registry
December 10, 2004
CompletedFirst Posted
Study publicly available on registry
December 10, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2007
CompletedApril 30, 2009
April 1, 2009
2.3 years
December 10, 2004
April 28, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Overall Survival
Secondary Outcomes (7)
Objective tumor response rate
Duration of objective tumor response rate
Progression-free survival
6 month and 12 month survival
Serum CA 19-9
- +2 more secondary outcomes
Interventions
Eligibility Criteria
You may qualify if:
- 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) for advanced/metastatic pancreatic cancer
- Measurable or nonmeasurable disease by RECIST criteria (at least one target or nontarget lesion)
- Recovered from reversible toxicities of prior therapy
- Karnofsky performance status ≥70
- 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
- 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
You may not qualify if:
- More than one prior systemic therapy regimen for metastatic/locally advanced pancreatic cancer (radiosensitizing doses of 5FU 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 study start
- Symptomatic brain metastases (baseline CT scan is not required in asymptomatic subjects)
- 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))
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Threshold Pharmaceuticalslead
- PPD Development, LPcollaborator
Study Sites (111)
Augusta Oncology Associates
Los Angeles, California, 90057, United States
Kenmar Research Institute
Los Angeles, California, 90057, United States
Mile High Oncology
Denver, Colorado, 80210, United States
Northwestern Connecticut Oncology - Hematology Associates
Torrington, Connecticut, 06790, United States
Palm Beach Institute of Hematology and Oncology
Boynton Beach, Florida, 33435, United States
Hematology/Oncology of the North Shore
Skokie, Illinois, 60076, United States
Fort Wayne Medical Oncology/Hem
Fort Wayne, Indiana, 46815, United States
Norton Healthcare Center
Louisville, Kentucky, 40202, United States
West Michigan Cancer Center
Kalamazoo, Michigan, 49007, United States
Hattiesburg Clinic Oncology
Hattiesburg, Mississippi, 39401, United States
Columbia Comprehensive Cancer Care Clinic
Columbia, Missouri, 65201, United States
Bond Clinic
Rolla, Missouri, 65401, United States
Deaconess Billings Clinic
Billings, Montana, 59101, United States
Office of Clinical Trials
Paramus, New Jersey, 07652, United States
New Mexico Oncology Hematology Consultants
Albuquerque, New Mexico, 87109, United States
Hanover Medical Specialists
Wilmington, North Carolina, 28401, United States
Vita Hematology Oncology PC
Bethlehem, Pennsylvania, 18015, United States
The Family Cancer Center , PLLC
Collierville, Tennessee, 38017, United States
Center for Oncology Research and Treatment
Dallas, Texas, 75230, United States
JPS Center for Cancer Care
Fort Worth, Texas, 76104, United States
Northern Utah Associates
Ogden, Utah, 84403, United States
Cancer Outreach Association
Abingdon, Virginia, 24211, United States
Marshfield Clinic Research Foundation
Marshfield, Wisconsin, 54449, United States
Hospital Interzonal General de Agudos
Buenos Aires, 1650, Argentina
Hospital Posadas
Buenos Aires, 1706, Argentina
Policlinica Privada Instituto de Medicina Nuclear
Buenos Aires, B8000FTS, Argentina
Hospital Udaondo
Buenos Aires, C1120AAF, Argentina
Hospital Alvarez
Buenos Aires, C1406FWY, Argentina
Hospital Churruca - Visca
Buenos Aires, C1437JCP, Argentina
Instituto Medico Alexander Fleming
Buenos Aires, Argentina
Instituto CAICI
Santa Fe, Argentina
Fundacao Pio XII - Hospital de Cancer de Barretos
Barretos, 14784-400, Brazil
Fundação Pio XII - Hospital de Câncer de Barretos
Barretos, 14784-400, Brazil
Hospital Vera Cruz - Clinica de Oncologia
Belo Horizonte, 30180-090, Brazil
Hospital Luxemburgo
Belo Horizonte, 30380-490, Brazil
Hospital de Clínicas da UFPR
Curitiba, 80060-900, Brazil
Associacao de Combate ao Cancer em Goias, Hospital Araujo Jorge, Setor de Oncologia Clinica
Goiânia, 74605-070, Brazil
Hospital Nossa Senhora da Conceicao
Porto Alegre, 91350-200, Brazil
Instituto Nacional do Cancer - INCA
Rio de Janeiro, 20231-050, Brazil
Grupo Paulista Oncologia Integrada
São Paulo, 01331-020, Brazil
Clinica de Oncologia Medica S/C Ltda
São Paulo, 01406100, Brazil
Hospital do Cancer - AC Camargo
São Paulo, 01509-900, Brazil
Department of Chemotherapy Dr. Georgi Stranski General Hospital of Pleven University
Pleven, 5800, Bulgaria
First Internal Department Plovdiv Regional Oncology Center with In-patient Department
Plovdiv, 4004, Bulgaria
Department of Chemotherapy Sofia Regional Oncology Center
Sofia, 1233, Bulgaria
Chemotherapy Clinic Queen Joanna General Hospital
Sofia, 1527, Bulgaria
Haematology and Oncology Clinic Military Medical Academy
Sofia, 1606, Bulgaria
Chemotherapy Clinic Specialized Oncology Hospital
Sofia, 1756, Bulgaria
Department of Medicinal Oncotherapy and Palliative Care Dr. Marko Markov Regional Oncology Center
Varna, 9010, Bulgaria
Department of Chemotherapy Veliko Tarnovo Regional Oncology Center
Veliko Tarnovo, 5000, Bulgaria
Fakultni nemocnice Brno Oddeleni Klinicke Onkologie
Brno, Czechia
Masarykuv onkologicky Ustav
Brno, Czechia
Krajska nemocnice Pardubice,oddeleni Radiacni Onkologie
Kyjevska, Czechia
Onkologicka Klinika, Fakultni nemocnice Olomouc
Olomouc, Czechia
Onkologicke Oddeleni, Batova krajska nemocnice Zlin
Zlín, Czechia
National Institute of Oncology
Budapest, Hungary
Szent Imre Korhaz Onkologia
Budapest, Hungary
Szent László Kórház, Onkológia
Budapest, Hungary
Vaszary Kolos Korhaz
Esztergom, Hungary
Petz Aladar County Hospital, Department of Oncology
Győr, Hungary
Baranya megyei Korhaz Onkologial osztaly
Rakoczi, Hungary
Bangalore Institute of Oncology
Bangalore, 560027, India
Curie Centre of Oncology
Bangalore, India
Radhakrishan Birla Cancer Centre
Jaipur, 302004, India
Jaslok Hospital and Research Centre
Mumbai, 400026, India
Sir Ganga Ram Hospital
New Delhi, India
Hospital Clinica del Parque
Chihuahua City, Chihuahua, 31000, Mexico
Hospital Universitario "Dr. Angel Leano"
Zapopan, Jalisco, 45200, Mexico
Hospital y Clinica OCA S.A. De C.V.
Monterrey, Nuevo León, 64000, Mexico
Hospital Central "Dr. Ignacio Morones Prieto" Departamento de Radioterapia.
San Luis Potosí City, San Luis Potosí, 78240, Mexico
Hospital regional ISSSTE "Merida"
Mérida, Yucatán, 97219, Mexico
Centro Estatal de Cancerologia
Chihuahua City, 31000, Mexico
Centro Medico ISSEMYM
Metepec, 52410, Mexico
Hospital general "5 de Diciembre" ISSSTE
Mexicali, 21100, Mexico
Hospital Regional de Especialidades No. 30 IMSS
Mexicali, 21100, Mexico
Hospital de Oncologia Centro Medico
Mexico City, 06720, Mexico
Instituto Nacional de Ciencias Medicas u Nutricion "Salvador Zubiran"
Mexico City, 14000, Mexico
Fundeni Clinical Institute
Bucharest, Romania
Trestioreanu Institute of Oncology
Bucharest, Romania
"I. Chiricuta" Institute of Oncology
Cluj-Napoca, Romania
Craiova Emergency Clinical County Hospital
Craiova, 1100, Romania
Timisoara City Hospital
Timișoara, Romania
Institute of Medical Radiology, Russian Academy of Medical Science
Obninsk, Kaluga Oblast, 249020, Russia
Cheliabinsk Regional Oncology Center
Chelyabinsk, 454087, Russia
Irkutsk Regional Oncology Center
Irkutsk, 664035, Russia
Clinical Oncology Center
Kazan', 420029, Russia
Krasnodar City Oncology Center
Krasnodar, 350040, Russia
Blokhin Cancer Research Center, Dept of Clinical Pharmacology and Chemotherapy
Moscow, 115478, Russia
Central Clinical Hospital of the presidentof the Russian Federation
Moscow, 121356, Russia
Hertzen Research Institute of Oncology
Moscow, 125284, Russia
Central Clinical Hospital of the Ministru of Transport n.a. Semashko
Moscow, 129128, Russia
Orenburg, Regional Oncology Center
Orenburg, 460021, Russia
St. Petersburg, Central Research Institute of Radiology
Saint Petersburg, 189646, Russia
Medical Academy of Postgraduate Education
Saint Petersburg, 193015, Russia
Mechnikov State Medical Academy
Saint Petersburg, 195065, Russia
St. Petersburg Oncology Center
Saint Petersburg, Russia
Samara Oncology Center
Samara, 443066, Russia
Voronezh Regional Clinical Oncology Center
Voronezh, 394000, Russia
Yaroslavl Regional Oncology Center
Yaroslavl, 150054, Russia
Dnepropetrovsk City Clinical Hospital
Dnipro, 49102, Ukraine
Donetsk Regional Antitumor Center
Donetsk, 83092, Ukraine
State Communal Healthcare Institution: Kharkov Regional Clinical Oncological Center
Kharkiv, 61070, Ukraine
Institute of Oncology under the Academy of Medical Sciences of Ukraine
Kiev, 03022, Ukraine
Kiev Municipal Clinical Hospital #10, Kiev Center for Biliary, Biliary tracts and Pancreas Surgery
Kiev, 03039, Ukraine
Krivoy Rog City Oncology Center
Kryvyi Rih, 50048, Ukraine
Lugansk Regional Clinical Oncological Center
Luhansk, 91047, Ukraine
Nikolaev Regional Oncology Centre
Mykolayiv, 54044, Ukraine
Odessa Regional Clinical Hospital
Odesa, 65025, Ukraine
Vinnitsa Regional Clinical Oncology Center
Vinnitsa, 21029, Ukraine
Zaporozhye Medical Academy of Postgraduate Education
Zaporizhzhya, 69096, Ukraine
Zhitomir Regional Clinical Hospital n.a. O.F. Gerbachevsky
Zhytomyr, 10002, Ukraine
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
December 10, 2004
First Posted
December 10, 2004
Study Start
September 1, 2004
Primary Completion
January 1, 2007
Study Completion
January 1, 2007
Last Updated
April 30, 2009
Record last verified: 2009-04