Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
61 participants
OBSERVATIONAL
2013-07-31
2014-04-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
The PFS (estimated from Kaplan-Meier estimate) will be the primary endpoints. In addition, the effects of sunitinib at the 2 periods of treatment (i.e. first line sunitinib vs. rechallenge) will be compared by Wilcoxon signed-rank test for PFS values and by McNemar test for overall response rate (ORR).
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
RETROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Non-Interventional Study
sunitinib: observational study
Observational study evaluating patients who were treated with sunitinib in 1st line and in 3rd line
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
sunitinib: observational study
Observational study evaluating patients who were treated with sunitinib in 1st line and in 3rd line
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Previously received sunitinib in first line, 2 or more antitumor therapies subsequently and then received sunitinib for a second time.
* At least 1 cycle of sunitinib rechallenge (1 cycle= 4 weeks on/2 weeks off).
* At least 1 measurable lesion that can be accurately measured in at least 1 dimension with the longest diameter (LD) ³ 10 mm when measured by spiral computerized tomography (CT) (5-mm slice thickness contiguous) or ³ 20 mm when measured by conventional CT (10-mm slice thickness contiguous). The lesion must be ³ 2 times the size of the slice thickness per RECIST criteria.
* Life expectancy of at least 3 months.
Exclusion Criteria
* Patient who received less than one line of treatment .
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Pfizer
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
CHU de la Timone
Marseille, Cedex 5, France
Hopital albert Michalon
Grenoble, Cedex 9, France
Departement d'Oncologie Medicale-Institut de Cancerologie de la Loire
Saint-Priest-en-Jarez, France, France
Centre Paul Papin
Angers, , France
Hôpital Saint-André
Bordeaux, , France
Centre Catalan Urologie Andrologie
Cabestany, , France
Centre Oscar Lambret - Cancérologie Urologie Digestive
Lille, , France
clinique de la Louvière
Lille, , France
Hopital Dupuytren - Oncologie Medicale
Limoges, , France
Centre Leon Berard, Service d'Oncologie Medicale
Lyon, , France
Institut Paoli-Calmettes / Hôpital de jour
Marseille, , France
Hopital Timone Adultes
Marseille, , France
Hopital Europeen Georges Pompidou
Paris, , France
Centre Eugene Marquis
Rennes, , France
CHU Charles Nicolle
Rouen, , France
Centre Rene Gauducheau - Service Oncologie Medicale
Saint-Herblain, , France
Institut Claudius Regaud
Toulouse, , France
Centre Alexis Vautrin
Vandœuvre-lès-Nancy, , France
Countries
Review the countries where the study has at least one active or historical site.
Related Links
Access external resources that provide additional context or updates about the study.
To obtain contact information for a study center near you, click here.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
ETUDE RESUME
Identifier Type: OTHER
Identifier Source: secondary_id
A6181211
Identifier Type: -
Identifier Source: org_study_id