Clinical trial NCT00443534: A Treatment Protocol For Patients Continuing From A Prior SU011248 Protocol.
Official title: A Treatment Protocol For Patients Continuing From A Prior SU011248 Protocol.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neoplasms
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2007-03-06
Enrollment: 123
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This protocol allows subjects who have participated in a previous SU011248 protocol the ability to continue to receive SU011248 after their study has ended.


Eligibility criteria: Inclusion Criteria:

* Participation in a previous SU011248 protocol and are judged by the investigator to have the potential to derive clinical benefit by remaining on SU011248 after the prior protocol ends.

Exclusion Criteria:

* Severe acute or chronic medical or psychiatric condition, or laboratory abnormality that may increase the risk associated with study participation or study drug administration, or may interfere with the interpretation of study results, and in the judgment of the investigator would make the patient inappropriate for entry into this study.

Primary outcomes:
measure: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: Baseline up to Day 28 after last dose of study treatment
Secondary outcomes:
Other outcomes:
measure: Overall Survival (OS)
timeFrame: Baseline, every 2 months until death or up to 2 years after the last dose of study treatment
measure: Progression-Free Survival (PFS)
timeFrame: Baseline, every 2 months until objective tumor progression or death or up to 2 years after the last dose of study medication
measure: Time to Tumor Progression (TTP)
timeFrame: Baseline, every 2 months until objective tumor progression or up to 2 years after the last dose of study medication
Locations:
city: Aurora
country: United States
facility: Pfizer Investigational Site
state: Colorado
city: Littleton
country: United States
facility: Pfizer Investigational Site
state: Colorado
city: Orlando
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Atlanta
country: United States
facility: Pfizer Investigational Site
state: Georgia
city: Harvey
country: United States
facility: Pfizer Investigational Site
state: Illinois
city: Harvey
country: United States
facility: Pfizer Investigational Site
state: Illinois
city: Maywood
country: United States
facility: Pfizer Investigational Site
state: Illinois
city: Tinley Park
country: United States
facility: Pfizer Investigational Site
state: Illinois
city: Zion
country: United States
facility: Pfizer Investigational Site
state: Illinois
city: Munster
country: United States
facility: Pfizer Investigational Site
state: Indiana
city: Baltimore
country: United States
facility: Pfizer Investigational Site
state: Maryland
city: Grand Rapids
country: United States
facility: Pfizer Investigational Site
state: Michigan
city: Creve Coeur
country: United States
facility: Pfizer Investigational Site
state: Missouri
city: St. Louis
country: United States
facility: Pfizer Investigational Site
state: Missouri
city: St. Peters
country: United States
facility: Pfizer Investigational Site
state: Missouri
city: Las Vegas
country: United States
facility: Pfizer Investigational Site
state: Nevada
city: Hackensack
country: United States
facility: Pfizer Investigational Site
state: New Jersey
city: Chapel Hill
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Clinton
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Goldsboro
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Hickory
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Wilson
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Oklahoma City
country: United States
facility: Pfizer Investigational Site
state: Oklahoma
city: Tulsa
country: United States
facility: Pfizer Investigational Site
state: Oklahoma
city: Tulsa
country: United States
facility: Pfizer Investigational Site
state: Oklahoma
city: Tulsa
country: United States
facility: Pfizer Investigational Site
state: Oklahoma
city: Hershey
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Greenville
country: United States
facility: Pfizer Investigational Site
state: South Carolina
city: Greer
country: United States
facility: Pfizer Investigational Site
state: South Carolina
city: Spartanburg
country: United States
facility: Pfizer Investigational Site
state: South Carolina
city: Bedford
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Dallas
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Fort Worth
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Houston
country: United States
facility: Pfizer Investigational Site
state: Texas
city: San Antonio
country: United States
facility: Pfizer Investigational Site
state: Texas
city: San Antonio
country: United States
facility: Pfizer Investigational Site
state: Texas
city: San Antonio
country: United States
facility: Pfizer Investigational Site
state: Texas
city: San Antonio
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Edmonton
country: Canada
facility: Pfizer Investigational Site
state: Alberta
city: Ottawa
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Montreal
country: Canada
facility: Pfizer Investigational Site
state: Quebec
city: Montreal
country: Canada
facility: Pfizer Investigational Site
state: Quebec
city: Montreal
country: Canada
facility: Pfizer Investigational Site
state: Quebec
city: Lyon Cedex 08
country: France
facility: Pfizer Investigational Site
city: Marseille Cedex 20
country: France
facility: Pfizer Investigational Site
city: Villejuif
country: France
facility: Pfizer Investigational Site
city: Berlin
country: Germany
facility: Pfizer Investigational Site
city: Grosshansdorf
country: Germany
facility: Pfizer Investigational Site
city: Hamburg
country: Germany
facility: Pfizer Investigational Site
city: Wiesbaden
country: Germany
facility: Pfizer Investigational Site
city: Bologna
country: Italy
facility: Pfizer Investigational Site
city: Cremona
country: Italy
facility: Pfizer Investigational Site
city: Genova
country: Italy
facility: Pfizer Investigational Site
city: Milano
country: Italy
facility: Pfizer Investigational Site
city: Orbassano (TO)
country: Italy
facility: Pfizer Investigational Site
city: Rozzano (MI)
country: Italy
facility: Pfizer Investigational Site
city: Elche
country: Spain
facility: Pfizer Investigational Site
state: Alicante
city: Barcelona
country: Spain
facility: Pfizer Investigational Site
city: Cordoba
country: Spain
facility: Pfizer Investigational Site
city: Sutton
country: United Kingdom
facility: Pfizer Investigational Site
state: Surrey
city: London
country: United Kingdom
facility: Pfizer Investigational Site
city: Manchester
country: United Kingdom
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: