Pancreatic CancerPhase 3NCT00099294
Study of the Efficacy and Safety of Glufosfamide Compared With Best Supportive Care in Metastatic Pancreatic Cancer
A Phase 3 study testing Glufosfamide in people with Pancreatic Cancer, run by Threshold Pharmaceuticals at 111 sites in 11 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Cancer
- What is being tested?
- Glufosfamide
- How many people
- 300 participants
- Where
- 111 sitesin 11 countries
- Study dates
- Sep 2004to Jan 2007
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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))
Trial locations and contacts
111 sites in 11 countries.
111 sites in 11 countries
United States23 sites
Cancer Outreach Association
Abingdon, Virginia, 24211
New Mexico Oncology Hematology Consultants
Albuquerque, New Mexico, 87109
Vita Hematology Oncology PC
Bethlehem, Pennsylvania, 18015
Deaconess Billings Clinic
Billings, Montana, 59101
Palm Beach Institute of Hematology and Oncology
Boynton Beach, Florida, 33435
The Family Cancer Center , PLLC
Collierville, Tennessee, 38017
Columbia Comprehensive Cancer Care Clinic
Columbia, Missouri, 65201
Center for Oncology Research and Treatment
Dallas, Texas, 75230
Mile High Oncology
Denver, Colorado, 80210
Fort Wayne Medical Oncology/Hem
Fort Wayne, Indiana, 46815
JPS Center for Cancer Care
Fort Worth, Texas, 76104
Hattiesburg Clinic Oncology
Hattiesburg, Mississippi, 39401
West Michigan Cancer Center
Kalamazoo, Michigan, 49007
Augusta Oncology Associates
Los Angeles, California, 90057
Kenmar Research Institute
Los Angeles, California, 90057
Norton Healthcare Center
Louisville, Kentucky, 40202
Marshfield Clinic Research Foundation
Marshfield, Wisconsin, 54449
Northern Utah Associates
Ogden, Utah, 84403
Office of Clinical Trials
Paramus, New Jersey, 07652
Bond Clinic
Rolla, Missouri, 65401
Hematology/Oncology of the North Shore
Skokie, Illinois, 60076
Northwestern Connecticut Oncology - Hematology Associates
Torrington, Connecticut, 06790
Hanover Medical Specialists
Wilmington, North Carolina, 28401
Russia17 sites
Cheliabinsk Regional Oncology Center
Chelyabinsk, 454087
Irkutsk Regional Oncology Center
Irkutsk, 664035
Clinical Oncology Center
Kazan', 420029
Krasnodar City Oncology Center
Krasnodar, 350040
Blokhin Cancer Research Center, Dept of Clinical Pharmacology and Chemotherapy
Moscow, 115478
Central Clinical Hospital of the presidentof the Russian Federation
Moscow, 121356
Hertzen Research Institute of Oncology
Moscow, 125284
Central Clinical Hospital of the Ministru of Transport n.a. Semashko
Moscow, 129128
Institute of Medical Radiology, Russian Academy of Medical Science
Obninsk, Kaluga Oblast, 249020
Orenburg, Regional Oncology Center
Orenburg, 460021
St. Petersburg, Central Research Institute of Radiology
Saint Petersburg, 189646
Medical Academy of Postgraduate Education
Saint Petersburg, 193015
Mechnikov State Medical Academy
Saint Petersburg, 195065
St. Petersburg Oncology Center
Saint Petersburg
Samara Oncology Center
Samara, 443066
Voronezh Regional Clinical Oncology Center
Voronezh, 394000
Yaroslavl Regional Oncology Center
Yaroslavl, 150054
Ukraine12 sites
Dnepropetrovsk City Clinical Hospital
Dnipro, 49102
Donetsk Regional Antitumor Center
Donetsk, 83092
State Communal Healthcare Institution: Kharkov Regional Clinical Oncological Center
Kharkiv, 61070
Institute of Oncology under the Academy of Medical Sciences of Ukraine
Kiev, 03022
Kiev Municipal Clinical Hospital #10, Kiev Center for Biliary, Biliary tracts and Pancreas Surgery
Kiev, 03039
Krivoy Rog City Oncology Center
Kryvyi Rih, 50048
Lugansk Regional Clinical Oncological Center
Luhansk, 91047
Nikolaev Regional Oncology Centre
Mykolayiv, 54044
Odessa Regional Clinical Hospital
Odesa, 65025
Vinnitsa Regional Clinical Oncology Center
Vinnitsa, 21029
Zaporozhye Medical Academy of Postgraduate Education
Zaporizhzhya, 69096
Zhitomir Regional Clinical Hospital n.a. O.F. Gerbachevsky
Zhytomyr, 10002
Brazil11 sites
Fundacao Pio XII - Hospital de Cancer de Barretos
Barretos, 14784-400
Fundação Pio XII - Hospital de Câncer de Barretos
Barretos, 14784-400
Hospital Vera Cruz - Clinica de Oncologia
Belo Horizonte, 30180-090
Hospital Luxemburgo
Belo Horizonte, 30380-490
Hospital de Clínicas da UFPR
Curitiba, 80060-900
Associacao de Combate ao Cancer em Goias, Hospital Araujo Jorge, Setor de Oncologia Clinica
Goiânia, 74605-070
Hospital Nossa Senhora da Conceicao
Porto Alegre, 91350-200
Instituto Nacional do Cancer - INCA
Rio de Janeiro, 20231-050
Grupo Paulista Oncologia Integrada
São Paulo, 01331-020
Clinica de Oncologia Medica S/C Ltda
São Paulo, 01406100
Hospital do Cancer - AC Camargo
São Paulo, 01509-900
Mexico11 sites
Hospital Clinica del Parque
Chihuahua City, Chihuahua, 31000
Centro Estatal de Cancerologia
Chihuahua City, 31000
Hospital regional ISSSTE "Merida"
Mérida, Yucatán, 97219
Centro Medico ISSEMYM
Metepec, 52410
Hospital general "5 de Diciembre" ISSSTE
Mexicali, 21100
Hospital Regional de Especialidades No. 30 IMSS
Mexicali, 21100
Hospital de Oncologia Centro Medico
Mexico City, 06720
Instituto Nacional de Ciencias Medicas u Nutricion "Salvador Zubiran"
Mexico City, 14000
Hospital y Clinica OCA S.A. De C.V.
Monterrey, Nuevo León, 64000
Hospital Central "Dr. Ignacio Morones Prieto" Departamento de Radioterapia.
San Luis Potosí City, San Luis Potosí, 78240
Hospital Universitario "Dr. Angel Leano"
Zapopan, Jalisco, 45200
Argentina8 sites
Hospital Interzonal General de Agudos
Buenos Aires, 1650
Hospital Posadas
Buenos Aires, 1706
Policlinica Privada Instituto de Medicina Nuclear
Buenos Aires, B8000FTS
Hospital Udaondo
Buenos Aires, C1120AAF
Hospital Alvarez
Buenos Aires, C1406FWY
Hospital Churruca - Visca
Buenos Aires, C1437JCP
Instituto Medico Alexander Fleming
Buenos Aires
Instituto CAICI
Santa Fe
Bulgaria8 sites
Department of Chemotherapy Dr. Georgi Stranski General Hospital of Pleven University
Pleven, 5800
First Internal Department Plovdiv Regional Oncology Center with In-patient Department
Plovdiv, 4004
Department of Chemotherapy Sofia Regional Oncology Center
Sofia, 1233
Chemotherapy Clinic Queen Joanna General Hospital
Sofia, 1527
Haematology and Oncology Clinic Military Medical Academy
Sofia, 1606
Chemotherapy Clinic Specialized Oncology Hospital
Sofia, 1756
Department of Medicinal Oncotherapy and Palliative Care Dr. Marko Markov Regional Oncology Center
Varna, 9010
Department of Chemotherapy Veliko Tarnovo Regional Oncology Center
Veliko Tarnovo, 5000
Hungary6 sites
National Institute of Oncology
Budapest
Szent Imre Korhaz Onkologia
Budapest
Szent László Kórház, Onkológia
Budapest
Vaszary Kolos Korhaz
Esztergom
Petz Aladar County Hospital, Department of Oncology
Győr
Baranya megyei Korhaz Onkologial osztaly
Rakoczi
Czechia5 sites
Fakultni nemocnice Brno Oddeleni Klinicke Onkologie
Brno
Masarykuv onkologicky Ustav
Brno
Krajska nemocnice Pardubice,oddeleni Radiacni Onkologie
Kyjevska
Onkologicka Klinika, Fakultni nemocnice Olomouc
Olomouc
Onkologicke Oddeleni, Batova krajska nemocnice Zlin
Zlín
India5 sites
Bangalore Institute of Oncology
Bangalore, 560027
Curie Centre of Oncology
Bangalore
Radhakrishan Birla Cancer Centre
Jaipur, 302004
Jaslok Hospital and Research Centre
Mumbai, 400026
Sir Ganga Ram Hospital
New Delhi
Romania5 sites
Fundeni Clinical Institute
Bucharest
Trestioreanu Institute of Oncology
Bucharest
"I. Chiricuta" Institute of Oncology
Cluj-Napoca
Craiova Emergency Clinical County Hospital
Craiova, 1100
Timisoara City Hospital
Timișoara
About this study
Official title: 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
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.
Read the detailed description
TH-CR-302 is a randomized Phase 3 study that will evaluate the efficacy and safety of glufosfamide plus best supportive care (BSC) compared to BSC alone for second line treatment of metastatic pancreatic cancer. BSC includes all medical or surgical interventions that a pancreatic cancer patient should receive to palliate the cancer but excludes treatment with systemic therapies intended to kill the cancer cells.
Study Hypothesis: Glufosfamide will provide benefits in survival to patients with metastatic pancreatic cancer over best supportive care.
Comparison: Glufosfamide versus best supportive care.
- Conditions
- Pancreatic Cancer
- Being tested
- Glufosfamide
- Keywords
- Pancreas, Cancer, Pancreatic Adenocarcinoma, Metastatic, Glufosfamide
- Medical subject headings
- Pancreatic Neoplasms, Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GlufosfamideDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Pain Intensity
Performance Status
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2004 (estimated)
- Study startSep 2004
- Primary completionJan 2007
- Study completionJan 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants
Sponsor and investigators
- Lead sponsor
- Threshold Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- PPD Development, LP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00099294
- Sponsor's protocol ID
- TH-CR-302
- Status last verified
- Apr 2009
- First submitted
- 10 Dec 2004
- Last updated
- 30 Apr 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT00099294
- Acronym / sponsor ID
- TH-CR-302
- Conditions
- Pancreatic Cancer
- Keywords
- Pancreas, Cancer, Pancreatic Adenocarcinoma, Metastatic, Glufosfamide
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants
- Lead sponsor
- Threshold PharmaceuticalsIndustry (pharma, biotech, devices)
- Collaborators
- PPD Development, LP
- Study start
- Sep 2004
- Primary completion
- Jan 2007 (actual)
- Study completion
- Jan 2007 (actual)
- First posted
- 10 Dec 2004 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
TH-CR-302 is a randomized Phase 3 study that will evaluate the efficacy and safety of glufosfamide plus best supportive care (BSC) compared to BSC alone for second line treatment of metastatic pancreatic cancer. BSC includes all medical or surgical interventions that a pancreatic cancer patient should receive to palliate the cancer but excludes treatment with systemic therapies intended to kill the cancer cells.
Study Hypothesis: Glufosfamide will provide benefits in survival to patients with metastatic pancreatic cancer over best supportive care.
Comparison: Glufosfamide versus best supportive care.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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)
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Glufosfamide | Drug | – |
Primary outcome
Overall Survival
7 secondary outcomes
Objective tumor response rate
Duration of objective tumor response rate
Progression-free survival
6 month and 12 month survival
Serum CA 19-9
Pain Intensity
Performance Status
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
111 sites in 11 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Glufosfamide in people with Pancreatic Cancer, run by Threshold Pharmaceuticals at 111 sites in 11 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Apr 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 111 sites in United States, Russia, Ukraine, Brazil, Mexico and 6 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Survival. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2009.