AzTrials
AzTrials

Colorectal NeoplasmsPhase 3NCT00056446

Study of Oxaliplatin/5-FU/Leucovorin Plus Vatalanib Versus Oxaliplatin/5-FU/Leucovorin in Patients With Previously Treated Metastatic Colorectal Cancer

A Phase 3 study testing Vatalanib in people with Colorectal Neoplasms and Colonic Neoplasms, run by Novartis Pharmaceuticals at 251 sites in 18 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The purpose of this study is to compare treatment with oxaliplatin/5-FU/leucovorin plus vatalanib versus oxaliplatin/5-FU/leucovorin plus placebo in patients with colorectal cancer that has spread to other organs and whose disease has worsened after treatment with irinotecan. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Vatalanib
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
855 participants
Where
251 sitesin 18 countries
Study dates
Jan 2003to 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

  • Confirmed adenocarcinoma of the colon or rectum in patients with metastatic disease
  • One prior chemotherapy regimen with irinotecan and 5FU
  • Evidence of progressive disease within 6 months after last dose of irinotecan
  • WHO Performance Status of 0, 1, or 2
  • Measurable tumors
  • Adequate hematologic status, liver and kidney function
  • Life expectancy greater than 12 weeks
  • Written informed consent obtained

Who cannot join

  • History or presence of central nervous system disease
  • Patients with a history of another primary cancer within 5 years
  • Prior chemotherapy within 3 weeks before entry to study
  • Major surgery within 4 weeks or minor surgery within 2 weeks before entry to study
  • Investigational drugs within 4 weeks before entry to study
  • Prior therapy with oxaliplatin
Show all 12Show fewer
  • Peripheral neuropathy with functional impairment
  • Female patients who are pregnant or breast feeding
  • Any severe or uncontrolled medical condition which could prevent participation in study
  • Chronic kidney disease
  • Acute or chronic liver disease
  • Patients taking Coumadin

Trial locations and contacts

251 sites in 18 countries.

251 sites in 18 countries

United States143 sites

  • Hematology/Oncology Associates

    Albuquerque, New Mexico, 87102

  • New Mexico Oncology/Hematology

    Albuquerque, New Mexico, 87109

  • Cabrini Center for Cancer Care

    Alexandria, Louisiana, 71301

  • Harrington Cancer Center

    Amarillo, Texas, 79106

  • Alaska Oncology and Hematology

    Anchorage, Alaska, 99508

  • University of Michigan

    Ann Arbor, Michigan, 48109-0934

  • Comprehensive Blood and Cancer Center

    Bakersfield, California, 93309

  • St. Agnes Healthcare

    Baltimore, Maryland, 21229-5299

  • Franklin Square Hospital Center

    Baltimore, Maryland, 21237

  • Southwestern Vermont Health Care

    Bennington, Vermont, 05201

  • The Center for Hematology and Oncology

    Boca Raton, Florida, 33486

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263

  • Providence St. Joseph Medical Center

    Burbank, California, 91505

  • Nashat Gabrail, M.D.

    Canton, Ohio, 44718

  • Lineberger Comprehensive Cancer Center

    Chapel Hill, North Carolina, 27599-7305

  • Charleston Cancer Center

    Charleston, South Carolina, 29406

  • Carolinas Hematology/Oncology Associates

    Charlotte, North Carolina, 28203

  • Erlanger Health System

    Chattanooga, Tennessee, 37403

  • Center for Cancer and Hematologic Disease

    Cherry Hill, New Jersey, 08003

  • University of Chicago medical Center, Hematology/Oncology

    Chicago, Illinois, 60637

  • Clarksville Regional Hematology/Oncology

    Clarksville, Tennessee, 37043

  • Case Western Reserve University

    Cleveland, Ohio, 44106-5056

  • The Cleveland Clinic Foundation

    Cleveland, Ohio, 44195

  • North Idaho Cancer Center

    Coeur d'Alene, Idaho, 83814

  • South Carolina Oncology Associates

    Columbia, South Carolina, 29201

  • WJB Dom VAMC

    Columbia, South Carolina, 29209

  • Columbus CCOP

    Columbus, Ohio, 43206

  • Center for Oncology Research & Treatment

    Dallas, Texas, 75230

  • Clinical Hematology & Oncology

    Dallas, Texas, 75235

  • Mile High Oncology

    Denver, Colorado, 80210

  • Rocky Mountain Cancer Center

    Denver, Colorado, 80220

  • Consultants in Medical Oncology & Hematology

    Drexel Hill, Pennsylvania, 19026

  • Hematology & Oncology Associates of NE PA

    Dunmore, Pennsylvania, 18512

  • Hematology/Oncology Associates of Central NY

    East Syracuse, New York, 13057

  • Western Washington Clinic

    Everett, Washington, 98201

  • Florida Cancer Specialists

    Fort Myers, Florida, 33901

  • Fort Wayne Medical Oncology & Hematology, Inc.

    Fort Wayne, Indiana, 46815

  • Compassionate Cancer Care Medical Group, Inc.

    Fountain Valley, California, 92708

  • Queens Medical Associates, PC

    Fresh Meadows, New York, 11365

  • California Oncology of the Central Valley

    Fresno, California, 93710

  • Virginia K. Crosson Cancer Center

    Fullerton, California, 92835

  • The Jones Clinic

    Germantown, Tennessee, 38138

  • Glendale Adventist Medical Center

    Glendale, California, 91206

  • Charles R. Wood Cancer Center

    Glens Falls, New York, 12801

  • Spectrum Health -- Cook Research Dept.

    Grand Rapids, Michigan, 49503

  • North Central Montana Professional Building

    Great Falls, Montana, 59405

  • Cancer Center of the Carolinas

    Greenville, South Carolina, 29615

  • Penn State Hershey Medical Center

    Hershey, Pennsylvania, 17033-0850

  • NH Oncology-Hematology, PA

    Hooksett, New Hampshire, 03106

  • Oncology Consultants

    Houston, Texas, 77024

  • H. Alejandro Preti, M.D., PA

    Houston, Texas, 77030

  • M.D. Anderson Cancer Center

    Houston, Texas, 77030

  • Comprehensive Cancer Institute

    Huntsville, Alabama, 35801

  • Northeast Arkansas Clinic

    Jonesboro, Arkansas, 72401

  • Heartland Hematology

    Kansas City, Missouri, 64118

  • Cascade Cancer Center

    Kirkland, Washington, 98034

  • Baptist Regional Cancer Center

    Knoxville, Tennessee, 37920

  • Scripps Green Hospital

    La Jolla, California, 92037

  • Wilshire Oncology Medical Group

    La Verne, California, 91767

  • Hematology Oncology Associates

    Lake Worth, Florida, 33461-4710

  • Comprehensive Cancer Centers of Nevada

    Las Vegas, Nevada, 89109

  • Nevada Cancer Center

    Las Vegas, Nevada, 89109

  • Arkansas Cancer Research Center

    Little Rock, Arkansas, 72205

  • Little Rock Hematology & Oncology

    Little Rock, Arkansas, 72205

  • St. Barnabas Cancer Center

    Livingston, New Jersey, 07039

  • Pacific Shores Medical Group

    Long Beach, California, 90813

  • USC Norris Cancer Center

    Los Angeles, California, 90033

  • Synergy Hematology-Oncology Medical Associates

    Los Angeles, California, 90036

  • Novartis Investigative Site

    Los Angeles, California, 90095

  • UCLA School of Medicine

    Los Angeles, California, 90095

  • Vijay Raghaven, M.D.

    Louisville, Kentucky, 40215

  • Manchester Hematology/Oncology Assoc.

    Manchester, Connecticut, 06040

  • North Shore University Hospital

    Manhasset, New York, 11030

  • Atlanta Cancer Care

    Marietta, Georgia, 30060

  • University of Tennessee Cancer Institute

    Memphis, Tennessee, 38104

  • University of Miami School of Medicine

    Miami, Florida, 33136

  • Oncology/Hematology Group of South Florida

    Miami, Florida, 33176

  • Minnesota CGOP

    Minneapolis, Minnesota, 55407

  • Monongahela Valley Hospital

    Monongahela, Pennsylvania, 15063

  • Eddie Hong-Lung Hu, M.D.

    Monterey Park, California, 91754

  • West Virginia University Health Sciences Center

    Morgantown, West Virginia, 26506

  • Hematology Oncology Associates of Northern New Jersey

    Morristown, New Jersey, 07960

  • Munster Community Hospital

    Munster, Indiana, 46321

  • Sarah Cannon Cancer Center

    Nashville, Tennessee, 37203

  • Meharry Medical College

    Nashville, Tennessee, 37208

  • Vanderbilt-Ingram Cancer Center

    Nashville, Tennessee, 37212

  • Vanderbilt University School of Medicine

    Nashville, Tennessee, 37232-6307

  • LSU Medical Center

    New Orleans, Louisiana, 70112

  • Tulane University Health Sciences Center

    New Orleans, Louisiana, 70112

  • St. Vincent's Catholic Medical Centers of New York

    New York, New York, 10011

  • Virginia Oncology Associates

    Norfolk, Virginia, 23502

  • North Valley Hematology/Oncology Medical Group

    Northridge, California, 91328

  • Hematology-Oncology Associates of Rockland

    Nyack, New York, 10956

  • Northern Utah Cancer Associates

    Ogden, Utah, 84403

  • The University of Oklahoma Health Sciences Center

    Oklahoma City, Oklahoma, 73104

  • Medical Oncology Care Associates

    Orange, California, 92868

  • Owensboro Medical Health System

    Owensboro, Kentucky, 42303

  • Ventura County Hematology-Oncology Specialists

    Oxnard, California, 93030

  • Oncology Hematology Associates of Central Illinois, PC

    Peoria, Illinois, 61602

  • Thomas Jefferson University Hospital

    Philadelphia, Pennsylvania, 19107

  • Allegheny General Hospital

    Pittsburgh, Pennsylvania, 15212-4772

  • UPMC Cancer Pavillion

    Pittsburgh, Pennsylvania, 15232

  • Hematology Oncology Associates of Treasure Coast

    Port Saint Lucie, Florida, 34952

  • Sierra View District Hospital

    Porterville, California, 93257

  • Cancer Treatment Centers of America in Hampton Roads

    Portsmouth, Virginia, 23704

  • Rainier Oncology

    Puyallup, Washington, 98372

  • Cancer Care Associates Medical Group, Inc.

    Redondo Beach, California, 90277

  • Pluta Cancer Center

    Rochester, New York, 14623

  • James P. Wilmot Cancer Center

    Rochester, New York, 14642

  • Kaiser Permanente

    Rockville, Maryland, 20850

  • Missouri Cancer Care, PC

    Saint Charles, Missouri, 63301

  • Oncology Care Associates, PLLC

    Saint Joseph, Michigan, 49085

  • South Texas Oncology & Hematology

    San Antonio, Texas, 78207

  • Santa Clara Valley Medical Center

    San Jose, California, 95128

  • Sansum Santa Barbara Foundation Medical Clinic

    Santa Barbara, California, 93105

  • Santa Barbara Hematology Oncology Medical Group, Inc.

    Santa Barbara, California, 93105

  • Office of Research

    Savannah, Georgia, 31405

  • Coastal Hematology & Oncology

    Savannah, Georgia, 31406

  • Maine Center for Cancer Medicine & Blood Disorders

    Scarborough, Maine, 04074

  • Virginia Mason Medical Center

    Seattle, Washington, 98101

  • Swedish Cancer Institute

    Seattle, Washington, 98104

  • LSU Health Sciences Center

    Shreveport, Louisiana, 71130-3932

  • Northshore Cancer Research Association

    Skokie, Illinois, 60076

  • Midwest Cancer Research Group

    Skokie, Illinois, 60077

  • Providence Cancer Center

    Southfield, Michigan, 48075

  • Spartanburg Regional Medical Center

    Spartanburg, South Carolina, 29303

  • Highlands Oncology Group

    Springdale, Arkansas, 72764

  • Saint Louis University

    St Louis, Missouri, 63110

  • Washington University School of Medicine

    St Louis, Missouri, 63110

  • Missouri Baptist Cancer Center

    St Louis, Missouri, 63131

  • Arch Medical Services Incorporated

    St Louis, Missouri, 63141

  • Scott & White Hospital

    Temple, Texas, 76508

  • Lewis Hall Singletary Oncology Center

    Thomasville, Georgia, 31792

  • Cotton O'Neil Oncology Clinic

    Topeka, Kansas, 66606

  • Arizona Clinical Research Center

    Tucson, Arizona, 85712

  • Oklahoma Oncology, Inc.

    Tulsa, Oklahoma, 74104

  • San Diego Cancer Center Medical Group

    Vista, California, 92083

  • Cooper Cancer Center

    Voorhees Township, New Jersey, 08043

  • Washington Oncology/Hematology Center

    Washington D.C., District of Columbia, 20037

  • Waukesha Memorial Hospital

    Waukesha, Wisconsin, 53188

  • Kettle Morain Oncology

    West Bend, Wisconsin, 53095

  • Fallon Clinic at Worcester Medical Center

    Worcester, Massachusetts, 01605

  • Florida Medical Clinic

    Zephyrhills, Florida, 33542

Other trials in United States

Canada21 sites

  • Novartis Investigative Site

    Barrie, Ontario, L4M6M2

  • Novartis Investigative Site

    Brampton, Ontario, L6W 2Z8

  • Novartis Investigative Site

    Calgary, Alberta, T2N4N2

  • Novartis Investigative Site

    Greater Sudbury, Ontario, P3E 5J1

  • Novartis Investigative Site

    Greenfield Park, Quebec, J4V2H1

  • Novartis Investigative Site

    Hamilton, Ontario, L8V 5C2

  • Novartis Investigative Site

    Montreal, Quebec, H2L 4M1

  • Novartis Investigative Site

    Montreal, Quebec, H2W 1S6

  • Novartis Investigative Site

    Ottawa, Ontario, K1H 1C4

  • Novartis Investigative Site

    Penticton, British Columbia, V2A3G6

  • Novartis Investigative Site

    Sainte-Foy, Ontario, G1V 4G5

  • Novartis Investigative Site

    Saskatoon, Saskatchewan, S7N4H4

  • Novartis Investigative Site

    St. Catharines, Ontario, L2R5K3

  • Novartis Investigative Site

    Sydney, Nova Scotia, B1P 1P3

  • Novartis Investigative Site

    Thunder Bay, Ontario, P7A 7T1

  • Study site

    Toronto, Ontario, M4C 3E7

  • Novartis Investigative Site

    Toronto, Ontario, M4N3M5

  • Novartis Investigative Site

    Toronto, Ontario, M5G1X5

  • Novartis Investigative Site

    Toronto, Ontario

  • Novartis Investigative Site

    Windsor, Ontario, N8W 2X3

  • Novartis Investigative Site

    Winnepeg, Manitoba, R2H 2A6

Other trials in Canada

Germany19 sites

  • Novartis Investigative Site

    Augsburg, 86150

  • Novartis Investigative Site

    Berlin, 13585

  • Novartis Investigative Site

    Berlin, 14195

  • Novartis Investigative Site

    Bielefeld, 33604

  • Novartis Investigative Site

    Braunschweig, 38100

  • Novartis Investigative Site

    Cologne, 50677

  • Novartis Investigative Site

    Dessau, 6822

  • Novartis Investigative Site

    Dresden, 1307

  • Novartis Investigative Site

    Essen, 45122

  • Novartis Investigative Site

    Essen, 45136

  • Novartis Investigative Site

    Frankfurt, 60488

  • Novartis Investigative Site

    Hamburg, 22087

  • Novartis Investigative Site

    Hanover, 30625

  • Novartis Investigative Site

    Magdeburg, 39002

  • Novartis Investigative Site

    München, 81675

  • Novartis Investigative Site

    Neumünster, 24534

  • Novartis Investigative Site

    Trier, 54290

  • Novartis Investigative Site

    Ulm, 89081

  • Novartis Investigative Site

    Wiesbaden, 65199

Other trials in Germany

Italy12 sites

  • Novartis Investigative Site

    Ancona, 60020

  • Novartis Investigative Site

    Bergamo, 24128

  • Novartis Investigative Site

    Brescia, 25124

  • Novartis Investigative Site

    Cremona, 26100

  • Novartis Investigative Site

    Genova, 16132

  • Novartis Investigative Site

    Livorno, 57100

  • Novartis Investigative Site

    Milan, 20100

  • Novartis Investigative Site

    Milan, 20141

  • Novartis Investigative Site

    Reggio Emilia, 42100

  • Novartis Investigative Site

    Roma, 135

  • Novartis Investigative Site

    Roma, 149

  • Novartis Investigative Site

    Rozzano, 20089

Other trials in Italy

France10 sites

  • Novartis Investigative Site

    Avignon, 84000

  • Novartis Investigative Site

    Boulogne, 92104

  • Novartis Investigative Site

    Lille, 59020

  • Novartis Investigative Site

    Marseille, 13385

  • Novartis Investigative Site

    Montpellier, 34298

  • Novartis Investigative Site

    Nice, 6189

  • Novartis Investigative Site

    Rennes, 35042

  • Novartis Investigative Site

    Saint-Herblain, 44805

  • Novartis Investigative Site

    Strasbourg, 67000

  • Novartis Investigative Site

    Toulouse, 31052

Other trials in France

Spain8 sites

  • Novartis Investigative Site

    Córdoba, 14004

  • Novartis Investigative Site

    Elche, 3202

  • Novartis Investigative Site

    Madrid, 28007

  • Novartis Investigative Site

    Madrid, 28033

  • Novartis Investigative Site

    Madrid, 28040

  • Novartis Investigative Site

    Madrid, 8907

  • Novartis Investigative Site

    Málaga, 29010

  • Novartis Investigative Site

    Zaragoza, 5009

Other trials in Spain

Taiwan7 sites

  • Novartis Investigative Site

    Changhua

  • Novartis Investigative Site

    Kaohsiung City

  • Novartis Investigative Site

    Keelung

  • Novartis Investigative Site

    Taichung

  • Novartis Investigative Site

    Tainan

  • Novartis Investigative Site

    Taipei

  • Novartis Investigative Site

    Taoyuan

Other trials in Taiwan

Belgium6 sites

  • Novartis Investigative Site

    Antwerp, 2020

  • Novartis Investigative Site

    Brasschaat, 2930

  • Novartis Investigative Site

    Brussels, 1200

  • Novartis Investigative Site

    Leuven

  • Novartis Investigative Site

    Liège, 4000

  • Novartis Investigative Site

    Wilrijk, 2610

Other trials in Belgium

Brazil6 sites

  • Novartis Investigative Site

    Porto Alegre RS, CEP 90 610-000

  • Novartis Investigative Site

    Salvador - Ba, 41825-010

  • Novartis Investigative Site

    Salvador, Bahia, CEP 40170-070

  • Novartis Investigative Site

    São Paulo, 01236-000

  • Novartis Investigative Site

    São Paulo, 01308-050

  • Novartis Investigative Site

    São Paulo, 01406-100

Other trials in Brazil

United Kingdom5 sites

  • Novartis Investigative Site

    Belfast, BT9 7AB

  • Novartis Investigative Site

    Birmingham, B15 2TH

  • Novartis Investigative Site

    Cardiff, CF147TB

  • Novartis Investigative Site

    London, W1T 3AA

  • Novartis Investigative Site

    Manchester, M20 4BX

Other trials in United Kingdom

New Zealand3 sites

  • Novartis Investigative Site

    Auckland

  • Novartis Investigative Site

    Christchurch

  • Novartis Investigative Site

    Wellington

Other trials in New Zealand

Australia2 sites

  • Novartis Investigative Site

    Frankston, VIC

  • Novartis Investigative Site

    Woodville South, SA

Other trials in Australia

Portugal2 sites

  • Novartis Investigative Site

    Coimbra, 3000-076

  • Novartis Investigative Site

    Lisbon, 1649-035

Other trials in Portugal

Sweden2 sites

  • Novartis Investigative Site

    Gothenburg, SE-416 85

  • Novartis Investigative Site

    Stockholm, SE-118 83

Other trials in Sweden

Switzerland2 sites

  • Novartis Investigative Site

    Bern, 3010

  • Novartis Investigative Site

    Thun, 3600

Other trials in Switzerland

Austria1 site

  • Novartis Investigative Site

    Sankt Veit an der Glan, 9300

Other trials in Austria

Hong Kong1 site

  • Novartis Investigative Site

    Chai Wan

Other trials in Hong Kong

Slovakia1 site

  • Novartis Investigative Site

    Bratislava, 81250

Other trials in Slovakia

About this study

Official title: A Randomized, Double-blind, Placebo-controlled, Phase III Study of Oxaliplatin/5-fluorouracil/Leucovorin With PTK787/ZK 222584 or Placebo in Patients With Previously Treated Metastatic Adenocarcinoma of the Colon or Rectum

The purpose of this study is to compare treatment with oxaliplatin/5-FU/leucovorin plus vatalanib versus oxaliplatin/5-FU/leucovorin plus placebo in patients with colorectal cancer that has spread to other organs and whose disease has worsened after treatment with irinotecan.

Being tested
Vatalanib
Keywords
Colorectal Cancer, Oxaliplatin, VEGF inhibitor, Vatalanib, PTK787, Colon Cancer, Colorectal Carcinoma, Rectal Cancer, Colorectal Tumor
Medical subject headings
Colorectal Neoplasms, Colonic Neoplasms, Rectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • VatalanibDrug

    Also called PTK787/ZK 222584

Study groups in NCT00056446
Study groupRoleWhat they receive
1ExperimentalOxaliplatin/5-FU/LV and PTK787/ZK 222584
Receives: Drug: Vatalanib
2Placebo comparatorOxaliplatin/5-FU/LV and placebo
Receives: Drug: Vatalanib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall survival

    Measured: throughout duration of study

Secondary outcomes (5)

  1. Progression free survival

    Measured: throughout duration of study

  2. Time to progression

    Measured: throughout duration of study

  3. Time to treatment failure

    Measured: throughout duration of study

  4. Tumor response rate

    Measured: throughout duration of study

  5. Tolerability and safety profile

    Measured: throughout duration of study

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Mar 2003 (estimated)
  2. Study startJan 2003
  3. Primary completionJan 2007
  4. Study completionJan 2007

Resources

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
Double blind
Enrolment
855 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00056446
Sponsor's protocol ID
CPTK787 0133/304946
Status last verified
Jan 2016
First submitted
13 Mar 2003
Last updated
6 Mar 2017
Results posted
No
Data monitoring committee
No

Publications

  • Van Cutsem E, Bajetta E, Valle J, Kohne CH, Hecht JR, Moore M, Germond C, Berg W, Chen BL, Jalava T, Lebwohl D, Meinhardt G, Laurent D, Lin E. Randomized, placebo-controlled, phase III study of oxaliplatin, fluorouracil, and leucovorin with or without PTK787/ZK 222584 in patients with previously treated metastatic colorectal adenocarcinoma. J Clin Oncol. 2011 May 20;29(15):2004-10. doi: 10.1200/JCO.2010.29.5436. Epub 2011 Apr 4.

    PubMed 21464401

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Vatalanib in people with Colorectal Neoplasms and Colonic Neoplasms, run by Novartis Pharmaceuticals at 251 sites in 18 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 8 inclusion and 12 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 6 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 251 sites in United States, Canada, Germany, Italy, France and 13 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. Some participants in this study may receive a placebo. 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 (time frame: throughout duration of study). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00056446, which also lists 1 linked publication.

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 6 Mar 2017.

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